Surekha Gangakhedkar — Direct/Cross
1,185 linesDIRECT EXAMINATION BY MR. LEACH:
MR. LEACH: THANK YOU. GOOD MORNING, MS. GANGAKHEDKAR. ARE YOU COMFORTABLE REMOVING YOUR MASK?
SUREKHA GANGAKHEDKAR: YES, I AM.
MR. LEACH: THANK YOU SO MUCH. ARE YOU APPEARING HERE TODAY PURSUANT TO A SUBPOENA TO TESTIFY?
JUDGE DAVILA: COULD YOU GET A LITTLE CLOSER TO THE MICROPHONE. IT MOVES. I THINK YOU CAN PULL IT TOWARDS YOU ALSO I BELIEVE. THERE WE ARE. THANK YOU VERY MUCH.
SUREKHA GANGAKHEDKAR: OKAY.
BY MR. LEACH:
MR. LEACH: I'VE PLACED BEFORE YOU A BINDER OF DOCUMENTS, AND I'D LIKE TO PLEASE DRAW YOUR ATTENTION TO WHAT HAS BEEN MARKED FOR IDENTIFICATION PURPOSES AS EXHIBIT 5402. IT SHOULD BE IN THE BACK.
MR. LEACH: DO YOU HAVE THAT IN FRONT OF YOU?
SUREKHA GANGAKHEDKAR: I DO.
MR. LEACH: IS THIS A DOCUMENT ENTITLED ORDER WITH A DATE ON PAGE 2 OF SEPTEMBER 14TH, 2021?
MR. LEACH: HAVE YOU SEEN THIS DOCUMENT BEFORE?
SUREKHA GANGAKHEDKAR: I HAVE.
MR. LEACH: OKAY. DO YOU UNDERSTAND THAT THE COURT HAS ISSUED AN ORDER THAT YOU SHALL TESTIFY UNDER OATH IN THIS CASE?
MR. LEACH: AND DO YOU UNDERSTAND THAT THE COURT HAS ORDERED THAT THE TESTIMONY AND OTHER INFORMATION COMPELLED FROM YOU PURSUANT TO THE ORDER MAY NOT BE USED AGAINST YOU IN A CRIMINAL CASE?
MR. LEACH: AND DO YOU UNDERSTAND THAT JUDGE DAVILA'S ORDER ALSO PROVIDES THAT ANY INFORMATION DIRECTLY OR INDIRECTLY DERIVED FROM YOUR TESTIMONY CANNOT BE USED AGAINST YOU IN A CRIMINAL CASE?
MR. LEACH: WOULD YOU PLEASE DESCRIBE YOUR EDUCATIONAL BACKGROUND FOR US?
SUREKHA GANGAKHEDKAR: YES. I COMPLETED MY BACHELOR'S OF SCIENCE IN INDIA, IN THE CITY OF HYDERABAD. AND WHEN I CAME TO THE U.S. I COMPLETED MY MASTER'S OF SCIENCE FROM SAN JOSE STATE UNIVERSITY. MOST RECENTLY I DO HAVE AN MBA FROM THE UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL.
MR. LEACH: THE UNIVERSITY OF NORTH CAROLINA?
MR. LEACH: OKAY. AND THE MASTER'S DEGREE FROM SAN JOSE STATE THAT YOU DESCRIBED, APPROXIMATELY WHEN DID YOU GET THAT?
SUREKHA GANGAKHEDKAR: I GRADUATED IN 1999.
MR. LEACH: AND I THINK YOU DESCRIBED IT AS A MASTER'S IN SCIENCE. WAS THERE A PARTICULAR FOCUS WITHIN THE SCIENCES THAT YOUR DEGREE IS IN?
SUREKHA GANGAKHEDKAR: IT'S IN CHEMISTRY.
MR. LEACH: CHEMISTRY. OKAY. AFTER YOU OBTAINED YOUR MASTER'S DEGREE IN CHEMISTRY FROM SAN JOSE STATE, WHAT DID YOU DO FOR A LIVING?
SUREKHA GANGAKHEDKAR: SO I WAS EMPLOYED AT A STARTUP COMPANY CALLED ACLARA BIOSCIENCES.
MR. LEACH: COULD YOU SPELL THAT FOR US?
SUREKHA GANGAKHEDKAR: YES. A-C-L-A-R-A, ACLARA, AND THEN BIOSCIENCES. IT IS ONE WORD, B-I-O-S-C-I-E-N-C-E-S.
MR. LEACH: THANK YOU SO MUCH. WHAT DID YOU DO AT ACLARA BIOSCIENCES?
SUREKHA GANGAKHEDKAR: SO MY JOB WAS TO DEVELOP ENZYME IMMUNOASSAYS ON THE PROPRIETARY SYSTEMS THAT THEY WERE BUILDING.
MR. LEACH: AND HOW LONG DID YOU WORK AT ACLARA BIOSCIENCES?
SUREKHA GANGAKHEDKAR: SO I WAS EMPLOYED THERE UNTIL 2005.
MR. LEACH: 2005?
MR. LEACH: OKAY. AND WHAT DID YOU DO IN 2005?
SUREKHA GANGAKHEDKAR: SO THE COMPANY, ACLARA BIOSCIENCES, MERGED WITH ANOTHER ORGANIZATION, AND THEY RELOCATED FROM MOUNTAIN VIEW TO SOUTH SAN FRANCISCO. SO THE COMMUTE WAS REALLY LONG FOR ME SO I RESIGNED FROM THAT POSITION, AND I WAS AT THAT POINT SEEKING FOR ADDITIONAL WORK.
MR. LEACH: OKAY. AND DID YOU FIND ADDITIONAL WORK SOMEWHERE?
SUREKHA GANGAKHEDKAR: YES, I DID. SO I JOINED THERANOS IN 2005.
MR. LEACH: IN 2005?
MR. LEACH: HOW BIG WAS THE COMPANY AT THAT POINT IN TIME IN 2005?
SUREKHA GANGAKHEDKAR: I WOULD THINK IT WAS APPROXIMATELY -- THERE WERE ABOUT LIKE 20 INDIVIDUALS, EMPLOYEES AT THAT TIME.
MR. LEACH: SO YOU WERE WITHIN ONE OF THE FIRST 25 PEOPLE TO START WORKING AT THERANOS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: OKAY. AND WHAT WERE YOU HIRED TO DO AT THERANOS?
SUREKHA GANGAKHEDKAR: I WAS HIRED TO DEVELOP ASSAYS AS A SENIOR SCIENTIST.
MR. LEACH: AND WHEN YOU SAY "DEVELOP ASSAYS," WHAT DO YOU MEAN BY THAT?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY DEVELOP TESTS THAT ARE ABLE TO DETECT CERTAIN LEVELS OF, SAY, LIKE PROTEINS IN SAMPLES.
MR. LEACH: AND DID YOU FOCUS ON A PARTICULAR AREA OF ASSAY DEVELOPMENT?
SUREKHA GANGAKHEDKAR: YES, THE FOCUS WAS ON A PARTICULAR TYPE OF ASSAY CALLED IMMUNOASSAYS.
MR. LEACH: IS THERE ANOTHER WORD THAT IS USED TO DESCRIBE IMMUNOASSAYS SUCH AS THE ONES THAT YOU WERE WORKING ON?
SUREKHA GANGAKHEDKAR: ALSO CALLED ELISA'S.
MR. LEACH: AND IS THAT E-L-I-S-A-S?
MR. LEACH: FOR PLURAL. AND YOU WERE A SENIOR SCIENTIST WHEN YOU STARTED?
MR. LEACH: AND OVER TIME WERE YOU PROMOTED WITHIN THERANOS?
SUREKHA GANGAKHEDKAR: YES. IN A FEW YEARS I WAS PROMOTED TO BE THE TEAM LEAD FOR THE GROUP AND EVENTUALLY I WAS PROMOTED TO BE THE MANAGER FOR THE ASSAY SYSTEMS.
MR. LEACH: AND ROUGHLY, WHEN DID YOU BECOME THE MANAGER OF SIEMENS ADVIA SYSTEMS WITHIN THERANOS?
SUREKHA GANGAKHEDKAR: I WOULD THINK APPROXIMATELY 2009.
MR. LEACH: AT THAT TIME PERIOD IN 2009, WHO DID YOU REPORT TO?
SUREKHA GANGAKHEDKAR: TO GARY FRENZEL.
MR. LEACH: OKAY. DID THAT CHANGE AT SOME POINT?
SUREKHA GANGAKHEDKAR: YES, IN THE NEXT FEW YEARS.
MR. LEACH: OKAY. AND WHO DID YOU REPORT TO AFTER THAT?
SUREKHA GANGAKHEDKAR: TO MS. ELIZABETH HOLMES.
MR. LEACH: AND WHAT WERE THE CIRCUMSTANCES THAT CAUSED YOU TO START REPORTING TO MS. HOLMES AS OPPOSED TO MR. FRENZEL?
SUREKHA GANGAKHEDKAR: SO I THINK GARY FRENZEL WAS GOING THROUGH SOME HEALTH ISSUES AND HE COULDN'T BE IN THE OFFICE AS FREQUENTLY, SO THAT WAS ONE OF THE REASONS THAT I WAS -- THAT THE REPORTING STRUCTURE CHANGED.
MR. LEACH: OKAY. AND DID YOU MEET WITH MS. HOLMES ON A REGULAR BASIS AS THE MANAGER OF ASSAY SYSTEMS?
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. LEACH: ALL RIGHT. AND DID SHE HAVE THE RIGHT TO DIRECT AND CONTROL YOUR WORK?
MR. LEACH: DID YOU -- HOW LONG DID YOU STAY AT THERANOS?
SUREKHA GANGAKHEDKAR: UNTIL 2013.
MR. LEACH: WHEN IN 2013 DID YOU LEAVE THERANOS?
SUREKHA GANGAKHEDKAR: SO I BELIEVE I TENDERED MY RECOGNITION IN THE FIRST WEEK IN SEPTEMBER. I THINK IT WAS AROUND SEPTEMBER 5TH.
MR. LEACH: OKAY. WHY DID YOU RESIGN FROM THERANOS?
SUREKHA GANGAKHEDKAR: SO PRIMARILY THE COMPANY WAS LOOKING TO LAUNCH ASSAYS ON THE PROPRIETARY DEVICES, AND I WAS NOT COMFORTABLE IN THE DIRECTION THAT THEY WERE GOING SO I DID NOT, I DID NOT -- I WAS NOT ALIGNED WITH SOME OF THOSE POSITIONS.
MR. LEACH: OKAY. WHEN YOU SAY YOU "WEREN'T COMFORTABLE," WHAT DO YOU MEAN BY THAT?
SUREKHA GANGAKHEDKAR: SO THE LAUNCH WAS GOING TO BE USING THE EDISON'S 3.0, OR 3.5'S. SO WE KNEW THAT THEY WERE DEVELOPMENT MACHINES THAT THE ASSAY DEVELOPMENT GROUP WAS USING TO DEVELOP ASSAYS.
JUDGE DAVILA: LOWER THAT MIKE A LITTLE IF YOU WOULD, PLEASE, AND THAT WILL BE HELPFUL. THANK YOU.
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY I DIDN'T THINK THAT THAT WAS THE RIGHT DECISION.
BY MR. LEACH:
MR. LEACH: WHAT DO YOU MEAN IT WASN'T THE RIGHT DECISION?
SUREKHA GANGAKHEDKAR: THE USE OF EDISON 3.0'S TO TEST CLINICAL SAMPLES.
MR. LEACH: WE'LL COME BACK IN A LITTLE BIT TO YOUR DECISION TO LEAVE, MS. GANGAKHEDKAR. BUT I THINK YOU ALSO TESTIFIED THAT YOU HAVE AN MBA FROM UNIVERSITY OF NORTH CAROLINA IN CHAPEL HILL. IS THAT SOMETHING THAT YOU GOT AFTER YOUR TENURE AT THERANOS?
SUREKHA GANGAKHEDKAR: YES. SO THAT WAS AN ONLINE DEGREE AND SO, YES, I DID GET MY MBA AFTER THERANOS.
MR. LEACH: AND WHERE ARE YOU WORKING TODAY?
SUREKHA GANGAKHEDKAR: I'M WORKING AT A COMPANY CALLED CEPHEID.
MR. LEACH: AND COULD YOU SPELL THAT FOR HE, PLEASE?
SUREKHA GANGAKHEDKAR: YEAH. C-E-P-H-E-I-D.
MR. LEACH: I WANT TO GO BACK IF WE COULD, MS. GANGAKHEDKAR, TO THE TIME PERIOD ROUGHLY 2005 TO 2010 AFTER YOU START AT THERANOS AND ESSENTIALLY UP UNTIL THE POINT THAT YOU BECOME THE MANAGER OF ASSAY SYSTEMS. AT A HIGH LEVEL DESCRIBE FOR US WHAT THE COMPANY WAS DOING WITH ITS ASSAY DEVELOPMENT DURING THAT TIME PERIOD?
SUREKHA GANGAKHEDKAR: YES. SO BASICALLY WE WERE -- THE GOAL WAS TO DOUBLE UP ASSAYS IN HOUSE ON THE PROPRIETARY THERANOS DEVICES THAT THE COMPANY WAS BUILDING.
MR. LEACH: WHEN YOU SAY THE "PROPRIETARY DEVICES," WHAT DO YOU MEAN? WHAT WERE THEY IN THIS TIME PERIOD?
SUREKHA GANGAKHEDKAR: SO THERE WERE SEVERAL ITERATIONS AND THE MOST RECENT ONE WERE CALLED THE EDISONS.
MR. LEACH: AND YOUR FOCUS IS ON ASSAY DEVELOPMENT. CAN YOU HELP US UNDERSTAND A LITTLE BIT WHAT THE PROCESS OF THAT IS, HOW YOU GO ABOUT DOING YOUR WORK?
SUREKHA GANGAKHEDKAR: YES. SO ESSENTIALLY WHEN A TARGET OF -- I THINK A TARGET WAS DEFINED AS TO WHICH PARTICULAR TEST WE WILL BE DEVELOPING THIS TEST FOR, SO WE WOULD CONDUCT THE RESEARCH, UNDERSTAND THE BACKGROUND OF WHAT THE TARGET IS, WHAT KIND OF REAGENTS ARE REQUIRED TO DEVELOP THIS TEST, ORDER THOSE, AND THEN CONDUCT SOME EXPERIMENTS TO OPTIMIZE THE TESTS, SO MAKING SURE THAT THE REAGENTS ARE APPROPRIATE, WE HAVE LIKE THE RIGHT EXPERIMENTAL CONDITIONS SO THAT WE HAVE A RELIABLE RESULT.
MR. LEACH: OKAY. AND WHAT IS A REAGENT?
SUREKHA GANGAKHEDKAR: SO IN THE CASE OF AN IMMUNOASSAY, THE REAGENT COULD EITHER BE ANTIBODIES THAT ARE USED TO DETECT THE TARGET IN QUESTION, IT COULD BE LIKE BUFFERS, ESSENTIALLY OTHER CHEMICALS THAT ARE USED TO SUPPORT THE EXPERIMENTAL RESULT.
MR. LEACH: AND YOU WERE WORKING ON DEVELOPING ASSAYS FOR USE ON A PARTICULAR DEVICE IN THIS TIME PERIOD?
MR. LEACH: AND I HEARD YOU USE THE TERM "EDISON." WAS THERE ALSO SOMETHING CALLED A 1.0?
SUREKHA GANGAKHEDKAR: YES. SO THAT WAS THE VERSION BEFORE THE EDISONS.
MR. LEACH: OKAY. WAS THERE SOMETHING BETWEEN THE 1.0 AND THE EDISONS?
SUREKHA GANGAKHEDKAR: I DON'T EXACTLY RECOLLECT AT THIS POINT, BUT THEY'RE VERY DIFFERENT ITERATIONS OF THE DEVICES.
MR. LEACH: OKAY. AND IN THE COURSE OF DEVELOPING ASSAYS FOR USE ON THE 1.0 AND THE EDISONS AND ANYTHING IN BETWEEN, DID YOU BECOME FAMILIAR WITH THE CAPABILITIES OF THOSE DEVICES?
MR. LEACH: OKAY. AND IN THIS TIME PERIOD, 2005 TO 2010, TO WHAT END WAS THERANOS DEVELOPING ASSAYS FOR USE ON A DEVICE? WAS THERE AN END CUSTOMER OR SOME CONSTITUENCY THAT YOU WERE WORKING TOWARDS?
SUREKHA GANGAKHEDKAR: SO MOSTLY I WOULD SAY THAT THERE WERE SEVERAL PROJECTS MOSTLY RELATED TO PHARMACEUTICAL COMPANIES.
MR. LEACH: AND DO YOU RECALL ANY OF THOSE PHARMACEUTICAL COMPANIES OFFHAND?
SUREKHA GANGAKHEDKAR: YES. SO THERE WAS GSK, THERE WAS CENTOCOR, THERE WAS CELGENE.
MR. LEACH: LET ME PLEASE DRAW YOUR ATTENTION TO WHAT WE HAVE MARKED AS EXHIBIT 112. IT SHOULD BE IN YOUR BINDER THERE. ARE YOU FAMILIAR WITH THIS DOCUMENT, MS. GANGAKHEDKAR?
MR. LEACH: IS THIS AN EMAIL THAT YOU RECEIVED FROM SOMEONE NAMED SUSAN DIGIAIMO DATED JUNE 11TH, 2008?
MR. LEACH: AND DOES THIS ALSO GO TO MS. HOLMES?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 112 INTO EVIDENCE.
JUDGE DAVILA: RIGHT. IT WILL BE ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 112 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN PLEASE ENLARGE THE TOP PART OF THE EMAIL. WONDERFUL.
MR. LEACH: MS. GANGAKHEDKAR, I DRAW YOUR ATTENTION TO THE FIRST EMAIL IN THE CHAIN. THIS IS TO A NUMBER OF INDIVIDUALS AT GSK.COM FROM SOMEONE NAMED NELSON RHODES AT GSK.COM. DO YOU SEE THAT?
MR. LEACH: AND WHAT IS GSK?
SUREKHA GANGAKHEDKAR: GLAXO SMITH KLINE.
MR. LEACH: IS THAT A MAJOR PHARMACEUTICAL COMPANY?
MR. LEACH: AND WHO IS NELSON RHODES?
SUREKHA GANGAKHEDKAR: SO HE WAS THE STUDY COORDINATOR FOR GSK.
MR. LEACH: I'M SORRY, THE STUDY COORDINATOR?
MR. LEACH: AND WHAT DO YOU MEAN BY THE -- WHAT WAS THE STUDY?
SUREKHA GANGAKHEDKAR: SO THERANOS HAD A STUDY WHERE WE WERE TESTING SOME SAMPLES THAT HAD BEEN PROVIDED BY THE STUDY COORDINATOR ON THE EDISON SYSTEMS.
MR. LEACH: OKAY. I'LL ASK YOU SOME MORE DETAILS ABOUT THAT, BUT FIRST WHO IS SUSAN DIGIAIMO?
SUREKHA GANGAKHEDKAR: SO I BELIEVE SHE WAS -- I BELIEVE SHE WAS THE COMMERCIAL LEAD FOR THERANOS.
MR. LEACH: OKAY. AND THE COMMERCIAL LEAD IS ESSENTIALLY A SALESPERSON?
SUREKHA GANGAKHEDKAR: I THINK SO, YEAH.
MR. LEACH: OKAY. AND THIS ULTIMATELY IS FORWARDED TO YOU, MS. HOLMES, THERE'S ALSO TWO INDIVIDUALS IN THE TO LINE, IAN GIBBONS AND GARY FRENZEL. CAN YOU JUST EXPLAIN WHO THEY WERE IN THIS TIME PERIOD?
SUREKHA GANGAKHEDKAR: SO GARY FRENZEL WAS MY MANAGER AND IAN GIBBONS WAS I THINK THE TECHNICAL LEAD, TECHNICAL LEAD FOR THE COMPANY.
MR. LEACH: OKAY. AND, MR. FRENZEL, IS THAT THE INDIVIDUAL WHO YOU REPLACED ESSENTIALLY AS THE MANAGER OF ASSAY SYSTEMS LATER ON IN TIME?
MR. LEACH: OKAY. MR. RHODES OR NELSON RHODES IS WRITING IN THE FIRST EMAIL, "PLEASE FIND THE ATTACHED METABOLIC BIOMARKER LAB SUMMARY OF THE THERANOS SYSTEMS EVALUATION THAT TOOK PLACE MAY 27TH-28, 2008." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND YOU'RE FAMILIAR WITH THAT STUDY?
MR. LEACH: AND DID YOU GO TO GSK TO ASSIST ABOUT THAT STUDY?
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. LEACH: AND DID YOU KEEP MS. HOLMES APPRISED DURING THIS STUDY OF WHAT WAS GOING ON?
MR. LEACH: OKAY. TELL US WHAT HAPPENED? WHAT WERE SOME OF THE DETAILS OF THE STUDY?
SUREKHA GANGAKHEDKAR: SO BASICALLY SUSAN AND I WENT TO THE LAB AT GSK, WE HAD A COUPLE OF SEVERAL OF THE EDISON INSTRUMENTS WITH US, AND SO THE STUDY COORDINATOR AT GSK, NELSON, WOULD GIVE US SAMPLES TO RUN IN THE LAB ON THEIR SYSTEMS, AND I WOULD RUN THOSE SAMPLES.
MR. LEACH: AND APPROXIMATELY HOW MANY SAMPLES DID YOU RUN?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT THE EXACT NUMBER.
MR. LEACH: IS IT MORE THAN 50?
SUREKHA GANGAKHEDKAR: APPROXIMATELY. YEAH.
MR. LEACH: OKAY. AND THE DOCUMENT -- THERE'S A DOCUMENT ATTACHED TO MS. DIGIAIMO'S EMAIL AND IT'S ENTITLED THERANOS EVALUATION SUMMARY 09 JUNE 2008.DOC. DO YOU SEE THAT?
MR. LEACH: AND THAT'S SOMETHING THAT YOU REVIEWED AT OR AROUND THE TIME THAT YOU RECEIVED THIS?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: OKAY. LET'S LOOK AT THAT DOCUMENT. IF WE CAN GO, PLEASE, TO PAGE 2 OF THE EXHIBIT.
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. LEACH: IF WE CAN HIGHLIGHT OR EXPAND THE ENTIRETY OF THE TEXT THERE, MS. HOLLIMAN, OR EXPAND THE ENTIRETY OF THE TEXT THERE. THANK YOU. MS. GANGAKHEDKAR, DO YOU SEE AT THE TOP WHERE IT SAYS BACKGROUND INFORMATION?
MR. LEACH: AND THEN IT READS, "ON MAY 27-28, 2008 THE THERANOS SYSTEM WAS EVALUATED TO GSK TO PROFILE ACTIVE GLP-1 AND C-PEPTIDE VALUES AND THESE DATA WERE COMPARE TO GOLD STANDARD ELISA'S USING FROZEN HUMAN PLASMA FROM STUDY AX," AND THE NUMBER CONTINUES. AND MY FIRST QUESTION IS WHAT IS GLP-1?
SUREKHA GANGAKHEDKAR: SO THAT'S A PEPTIDE HORMONE, SO THAT WAS THE TARGET FOR ONE OF THE TESTS.
MR. LEACH: THAT WAS THE TARGET OF THE DRUG THAT GSK WAS DEVELOPING?
SUREKHA GANGAKHEDKAR: I WOULD THINK SO, BUT THE GLP-1 IS THE ASSAY THAT WE WERE -- WE HAD DEVELOPED IN HOUSE.
MR. LEACH: OKAY. THANK YOU. IN THE NEXT FULL PARAGRAPH IT SAYS, "30 PLASMA SAMPLES (ASSAYED IN DUPLICATE) WERE CHOSEN BASED ON HISTORICAL GSK DATA FOR TOTAL GLP-1 LEVELS FROM SUBJECTS GIVEN A MIXED MEAL AND TWO FINGERPRICK BLOOD DRAWS WERE PERFORMED." DOES THAT REFRESH YOUR MEMORY ABOUT THE NUMBER OF SAMPLES THAT WERE USED IN THIS STUDY?
SUREKHA GANGAKHEDKAR: YES, IT DOES.
MR. LEACH: IT THEN SAYS, "FIVE THERANOS MACHINES WERE USED." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND DO YOU BELIEVE THAT TO BE ACCURATE?
MR. LEACH: OKAY. LET'S GO TO THE NEXT PAGE, PLEASE, PAGE 3. IF WE COULD ZOOM IN ON THE ENTIRETY OF THE TEXT, MS. HOLLIMAN. THANK YOU. DO YOU SEE THE GSK METABOLIC BIOMARKER LAB COMMENTS HEADING AT THE TOP, MS. GANGAKHEDKAR?
MR. LEACH: OKAY. AND THERE ARE A NUMBER OF BULLETS THERE THAT SAY, "DATA SHOW GOOD CORRELATION, MACHINES WORKED WELL, CARTRIDGES WERE PRETTY STRAIGHTFORWARD, FINGERPRICK/BLOOD DRAW PROCEDURE WAS DIFFICULT." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND ARE THESE THE CONCLUSIONS THAT GSK IS COMMUNICATING TO THERANOS BASED ON THIS TWO-DAY STUDY?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: OKAY. DID YOU VIEW THIS TWO DAY VALUATION, OR THIS TWO DAY STUDY AS VALUATION BY GSK OF THE THERANOS SYSTEM?
SUREKHA GANGAKHEDKAR: SO AT THAT POINT I THOUGHT SO.
MR. LEACH: DID YOU CONSIDER THIS A FEASIBILITY STUDY OR MORE FORMAL VALIDATION?
SUREKHA GANGAKHEDKAR: I THINK THIS WOULD FALL UNDER FEASIBILITY STUDY.
MR. LEACH: WHAT DO YOU MEAN BY THAT?
SUREKHA GANGAKHEDKAR: SO BASICALLY THIS WAS THE FIRST VALUATION FROM GSK TO SHOW HOW THE THERANOS SYSTEMS ARE BEHAVING.
MR. LEACH: OKAY. AND DO YOU CONTRAST IN YOUR MIND THE FEASIBILITY STUDY VERSUS FORMAL VALIDATION?
SUREKHA GANGAKHEDKAR: COULD YOU REPEAT YOUR QUESTION, PLEASE.
MR. LEACH: DO YOU DISTINGUISH BETWEEN THE CONCEPT OF A FEASIBILITY STUDY VERSUS FORMAL VALIDATION OF AN ASSAY?
SUREKHA GANGAKHEDKAR: I THINK SO, YES.
MR. LEACH: EXPLAIN THAT FOR US, PLEASE.
SUREKHA GANGAKHEDKAR: SO THE VALIDATION STUDY WOULD HAVE MORE EITHER EXAMPLES OR ADDITIONAL TESTS.
MR. LEACH: OKAY. AND MORE THAN THE 30 SAMPLES THAT ARE, THAT ARE AT ISSUE IN THIS STUDY?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: OKAY. DID YOU EVER TELL ANYBODY WITHIN THERANOS THAT GSK HAD COMPREHENSIVELY EVALUATED THERANOS'S TECHNOLOGY?
SUREKHA GANGAKHEDKAR: I -- I'M SORRY, DID I TELL ANYBODY?
MR. LEACH: DID YOU EVER TELL ANYBODY WITHIN THERANOS THAT GSK HAD COMPREHENSIVELY VALIDATED THERANOS' TECHNOLOGY?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT.
MR. LEACH: WOULD YOU HAVE SAID THAT TO ANYBODY?
SUREKHA GANGAKHEDKAR: MOST PROBABLY NOT.
MR. LEACH: WHY NOT?
SUREKHA GANGAKHEDKAR: BECAUSE AT THIS POINT I THINK I FELT THAT THIS WAS JUST A SINGLE STUDY, SO IN MY MIND IT WOULD HAVE BEEN A FEASIBILITY.
MR. LEACH: AFTER THIS TWO DAY FEASIBILITY STUDY WITH GSK, DID YOU DO ANY ADDITIONAL WORK WITH GSK?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT.
MR. LEACH: IF WE GO BACK TO PAGE 1 OF THE EMAIL, MS. DIGIAIMO WRITES THAT SHE'S GOING TO FOLLOW UP WITH FOLKS AT GSK ABOUT ADDITIONAL OPPORTUNITIES. DO YOU SEE THAT ON PAGE 1?
MR. LEACH: AND DO YOU KNOW IF ANYTHING EVER CAME OF THOSE ADDITIONAL OPPORTUNITIES?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT AT THIS TIME IF ANYTHING ELSE CAME OUR WAY.
MR. LEACH: YOUR HONOR, I THINK THIS IS A CONVENIENT TIME TO TAKE OUR BREAK.
JUDGE DAVILA: LET'S DO THAT, LADIES AND GENTLEMEN. LET'S TAKE OUR MIDDAY BREAK FOR PURPOSES OF THIS TRIAL. I'D LIKE TO TAKE ABOUT 45 MINUTES FOR YOU, PLEASE, 45 MINUTES. SO IF WE COULD HOPEFULLY SHOOT FOR A GOAL OF HAVING YOU BACK IN YOUR SEATS AND READY TO COME BACK AT ABOUT TEN TO THE HOUR, MS. KRATZMANN WILL COLLECT YOU. SO PLEASE REMEMBER DURING THE BREAK MY ADMONITION REMAINS. YOU'RE NOT TO DISCUSS OR DO ANY RESEARCH ABOUT ANYTHING INVOLVED WITH THIS CASE, YOU'RE NOT TO DISCUSS AMONGST YOURSELVES ANYTHING ABOUT THE CASE. ENJOY YOUR BREAK, AND WE'LL BE BACK -- I THINK WE'RE GOING TO FINISH AT 2:00 TODAY JUST FOR YOUR INFORMATION. AGAIN, WE'VE SCHEDULED THESE BREAKS, BUT IF ANYONE NEEDS TO TAKE AN UNSCHEDULED BREAK FOR ANY REASON, PLEASE JUST LET ME KNOW, RAISE YOUR HAND, AND WE CAN ACCOMMODATE THAT. SO, MS. KRATZMANN, IF YOU COULD ESCORT THE JURORS OUT, PLEASE. YOU MAY STAND DOWN.
(JURY OUT AT 11:04 A.M.)
JUDGE DAVILA: THANK YOU, MS. GANGAKHEDKAR. YOU CAN STAND DOWN. WE'LL SEE YOU BACK HERE AT ABOUT TEN TO THE HOUR, PLEASE.
SUREKHA GANGAKHEDKAR: THANK YOU.
JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. THANK YOU. ALL RIGHT. THANK YOU. THE RECORD SHOULD REFLECT THAT OUR JURY AND ALTERNATES HAVE LEFT THE COURTROOM. THE WITNESS HAS LEFT THE COURTROOM. ALL COUNSEL AND THE DEFENDANT ARE PRESENT. ANYTHING BEFORE WE TAKE OUR BREAK, COUNSEL?
MR. LEACH: NOTHING FROM THE GOVERNMENT, YOUR HONOR.
JUDGE DAVILA: OKAY. THANK YOU.
(LUNCH RECESS TAKEN AT 11:05 A.M.) AFTERNOON SESSION
(COURT CONVENED AT 11:57 A.M.)
(JURY IN AT 11:57 A.M.)
JUDGE DAVILA: WEAR BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE WITNESS IS ON THE STAND. BEFORE WE BEGIN, I JUST WANT TO SAY ONE THING, LADIES AND GENTLEMEN, IF YOU WOULD PLEASE DISABLE THE SOUND ON ANY DEVICE THAT YOU HAVE, I WOULD APPRECIATE IT. THAT WOULD BE HELPFUL. SOMETIMES DEVICES GO OFF UNINTENDED AND IT DOES -- AND IT CAN INTERRUPT THE PROCEEDINGS. SO IF YOU WOULD PLEASE TAKE A MOMENT TO ENSURE THAT ANY DEVICE THAT YOU HAVE, THE VOLUME IS TURNED OFF OR TURNED DOWN, I WOULD BE GRATEFUL. THANK YOU. MR. LEACH, DO YOU HAVE ADDITIONAL QUESTIONS?
MR. LEACH: I DO, YOUR HONOR. THANK YOU.
JUDGE DAVILA: PLEASE PROCEED. THANK YOU.
BY MR. LEACH:
MR. LEACH: GOOD MORNING, MS. GANGAKHEDKAR. WHEN WE BROKE WE WERE TALKING ABOUT SOME OF YOUR WORK WITH GSK IN THE 2008 TIME PERIOD. I'D LIKE TO MOVE FORWARD IN TIME, IF WE COULD, TO THE TIME PERIOD 2013. DO YOU HAVE THAT TIME PERIOD IN MIND?
MR. LEACH: AND WHAT WAS YOUR RESPONSIBILITY AT THERANOS IN THE 2013 TIME PERIOD?
SUREKHA GANGAKHEDKAR: SO WE WERE CONTINUING TO DEVELOP IMMUNOASSAYS ON THE EDISON DEVICES.
MR. LEACH: HOW IS THAT DEVELOPING IMMUNOASSAYS FOR THE EDISON DEVICES GOING?
SUREKHA GANGAKHEDKAR: SO WE WERE PROCEEDING WITH A LARGE NUMBER OF ASSAYS THAT HAD BEEN -- THERE WAS A LARGE LIST OF ASSAYS THAT HAD BEEN GIVEN TO US, AND SO WE WERE WORKING ALONG THE PRIORITY LIST THAT HAD BEEN PROVIDED.
MR. LEACH: AND WHEN YOU SAY ON THE EDISONS, IS THIS THE 3.0 AND THE 3.5?
SUREKHA GANGAKHEDKAR: PRIMARILY 3.0'S.
MR. LEACH: AND AT SOME POINT DID THAT WORK SHIFT TO A NEW ITERATION OR A NEXT GENERATION OF THE THERANOS DEVICE?
SUREKHA GANGAKHEDKAR: YES, IT DID.
MR. LEACH: TELL US ABOUT THAT, PLEASE.
SUREKHA GANGAKHEDKAR: SO THERE WAS THE NEXT GENERATION OF THE SYSTEMS THAT WERE BEING DEVELOPED. THEY WERE CALLED THE -- ROUGHLY CALLING THEM THE 4.0'S. SO THE EARLY INSTRUMENTS, THE EARLY VERSIONS OF THE INSTRUMENTS HAD BEEN PROVIDED AND THERE WAS SOME INITIAL TESTING OR QUALIFICATIONS THAT HAD STARTED ON THE 4.0'S.
MR. LEACH: AT THE TIME THAT YOU MOVED TO THE 4.0'S, HOW WOULD YOU CHARACTERIZE YOUR WORK WITH THE 3.0'S AND THE 3.5'S? HAD YOU FINISHED? WHERE WERE YOU?
SUREKHA GANGAKHEDKAR: SO WE WERE ON THE -- THERE WERE A FAIR NUMBER OF ASSAYS THAT HAD -- THAT WERE IN THE DEVELOPMENT OR HAD COMPLETED THE DEVELOPMENT STAGES.
MR. LEACH: OKAY. HAD ANY BEEN SUCCESSFULLY VALIDATED FOR USE IN THE CLIA LAB?
MR. LEACH: YOU MENTIONED YOU WERE WORKING ON A NUMBER OF PRIORITY ASSAYS. WHERE DID YOU GET THAT PRIORITY LIST FROM?
SUREKHA GANGAKHEDKAR: SO THAT LIST WAS SHARED TO US BY DR. DANIEL YOUNG.
MR. LEACH: AND WHO IS DANIEL YOUNG?
SUREKHA GANGAKHEDKAR: SO DANIEL YOUNG WAS THE VICE PRESIDENT, AND ESSENTIALLY I THINK HE WAS FUNCTIONING AS LIKE AKIN TO OUR CHIEF TECHNOLOGY OFFICER.
MR. LEACH: OKAY. DID HE REPORT TO MS. HOLMES?
SUREKHA GANGAKHEDKAR: I THINK HE DID.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO WHAT HAS BEEN MARKED AS 5077. DO YOU HAVE THAT IN YOUR BINDER?
MR. LEACH: DO YOU SEE -- IS THIS AN EMAIL INVOLVING YOU AND A NUMBER OF OTHER INDIVIDUALS WITHIN YOUR TEAM?
MR. LEACH: AND IN THE MIDDLE OF THE PAGE DO YOU SEE THERE'S AN EMAIL FROM YOU DATED MARCH 4TH, 2013?
MR. LEACH: DO YOU SEE THAT THE SUBJECT IS NEW PROJECT?
MR. LEACH: OKAY. AT A HIGH LEVEL, WHAT ARE YOU COMMUNICATING IN THIS EMAIL?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY I AM TELLING MY TEAM THAT A NEW PROJECT -- I THINK WE WERE WORKING ON THIS NEW PROJECT AND HOW WE ARE SUPPOSED TO BE, LIKE, PLANNING FOR THE WORK THAT WILL BE INCLUDED IN IT.
MR. LEACH: AND WHERE DID YOU GET THESE PLANS FROM?
SUREKHA GANGAKHEDKAR: THE PLAN FOR THE PROJECT OR --
MR. LEACH: YES.
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY WE WERE ASKED TO -- AFTER DISCUSSIONS WITH EITHER, LIKE, MS. HOLMES OR DR. YOUNG.
MR. LEACH: AND ARE YOU ATTEMPTING TO COMMUNICATE YOUR TEAM DIRECTIONS YOU'VE RECEIVED FROM MS. HOLMES ABOUT DEVELOPING ASSAYS FOR USE ON THE 4.0 DEVICE?
SUREKHA GANGAKHEDKAR: SO I WOULD SAY IT'S A COMBINATION OF BOTH. SO BASICALLY WE HAVE BEEN PROVIDED THIS NEW PROJECT, AND YOU HAVE THE OVERALL PLAN THERE, BUT THE FINE -- THE ADDITIONAL DETAILS ON HOW WE WOULD GET THERE IS BEING PLANNED BY ME.
MR. LEACH: OKAY. YOUR HONOR, I OFFER EXHIBIT 5077 INTO EVIDENCE.
JUDGE DAVILA: IT'S RECEIVED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5077 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: AND IF WE CAN START WITH THE FIRST EMAIL ROUGHLY HALF WAY DOWN THE PAGE, AND IF WE CAN ZOOM IN ON THE ENTIRETY OF THE TEXT FROM RIGHT THERE. A LITTLE DOWN FURTHERMORE. WONDERFUL. THANK YOU, MS. HOLLIMAN. MS. GANGAKHEDKAR, DO YOU SEE YOUR NAME IN THE FROM LINE HERE?
MR. LEACH: AND THERE'S A NUMBER OF INDIVIDUALS IN THE TO LINE. I DON'T WANT TO GO THROUGH EVERY ONE, BUT AT A HIGH LEVEL CAN YOU DESCRIBE WHO THESE FOLKS IN THE TO LINE ARE?
SUREKHA GANGAKHEDKAR: SO MOSTLY THEY ARE MEMBERS OF THE ELISA ASSAY DEVELOPMENT TEAM AS WELL AS THE TEAM INVOLVED IN THE MANUFACTURING OF AND THE FORMULATION TEAMS FOR THE CARTRIDGES.
MR. LEACH: AND THE MANUFACTURING FOR THE CARTRIDGES FOR THE 4.0?
SUREKHA GANGAKHEDKAR: FOR THE USE OF THIS STUDY.
MR. LEACH: OKAY. AND YOU WRITE IN THE BEGINNING OF THE EMAIL, "HI ALL, CONFIDENTIAL INFORMATION -- NOT TO BE DISCUSSED WITH OTHER GROUPS OR OPENLY IN THE LAB." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHY DID YOU WRITE THAT LANGUAGE?
SUREKHA GANGAKHEDKAR: SO THERE WERE GENERAL DIRECTIONS FROM MS. HOLMES THAT ANY NEW PROJECTS THAT WE ARE WORKING ON SHOULD BE, THE INFORMATION SHOULD BE LIMITED ONLY TO THE INDIVIDUALS WHO ARE WORKING ON THEM, AND WE SHOULDN'T BE OPENLY DISCUSSING DETAILS OF THE PROJECTS OR THE PLANS WITH OTHER EMPLOYEES IN THE COMPANY.
MR. LEACH: SO YOU WORKED IN THE ELISA GROUP, THE IMMUNOASSAY GROUP?
MR. LEACH: AND DID YOU FEEL FREE TO SHARE DETAILS AND INSIGHTS OF THE ELISA GROUP WITH GROUPS WORKING WITH OTHER TYPES OF ASSAYS?
SUREKHA GANGAKHEDKAR: NO, I DID NOT.
MR. LEACH: AND DID YOU FEEL FREE TO SHARE DETAILS OF ASPECTS OF YOUR ELISA WORK WITH FOLKS WHO WERE WORKING ON MANUFACTURING THE THERANOS ANALYZERS?
MR. LEACH: WAS THAT A MATTER OF FRUSTRATION TO YOU?
MR. LEACH: HOW SO?
SUREKHA GANGAKHEDKAR: WELL, IN CERTAIN TIMES IF WE WERE WORKING ON THE EDISONS, THEY WOULDN'T -- WE DIDN'T HAVE AN OPTION TO, LIKE, TALK OR DISCUSS SPECIFIC ISSUES EITHER WITH THE HARDWARE OR THE SOFTWARE TEAMS, SO THERE GENERALLY WAS A GUIDANCE NOT TO SHARE ALL DETAILS SAY, FOR INSTANCE, OF THE ASSAYS OR THE CHEMISTRY PART WITH THE HARDWARE TEAMS OR THE SOFTWARE TEAMS AND VICE VERSA.
MR. LEACH: AND DID THAT MAKE YOUR WORK HARDER?
SUREKHA GANGAKHEDKAR: YES, IT DID.
MR. LEACH: AND HOW SO?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE THERE WERE ISSUES RELATED TO THE OTHER FUNCTIONS, AND WE COULDN'T UNDERSTAND THEM AND KNOW ENTIRELY WHAT IMPACT IT WOULD HAVE ON OUR FUNCTIONS. AND THE SAME FOR IF THERE WERE ISSUES WE WERE EXPERIENCING WITH THE ASSAYS, WE WOULDN'T KNOW HOW IT WOULD WORK FULLY WITH THE OTHER TWO FUNCTIONS.
MR. LEACH: DID YOU FEEL AS IF INFORMATION AT THERANOS WAS SILOED?
MR. LEACH: AND WHERE DID THIS SILOING COME FROM? AT WHOSE DIRECTION?
SUREKHA GANGAKHEDKAR: SO IT EITHER CAME FROM MS. HOLMES OR MR. BALWANI.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO THE FIRST PARAGRAPH OF THE EMAIL. IT SAYS, "THIS EMAIL IS TO PROVIDE YOU A HEADS UP ON A NEW (KEY) PROJECT FOR THE 4.0 DEVICES. THE PLAN IS TO VALIDATE (510K) THE FLU A AND B MULTIPLEX ON THE 4.0 DEVICES." WHAT DID YOU MEAN BY "THE FLU A AND B MULTIPLEX ON THE 4.0 DEVICES"?
SUREKHA GANGAKHEDKAR: THE FLU A AND B ARE THE ASSAY TARGETS. IT'S A MULTIPLEX AND THE VERSION OF THE DEVICE WOULD BE THE 4.0.
MR. LEACH: AND THEN TOWARDS THE END OF THE PARAGRAPH YOU WROTE, "THIS PROJECT WILL HAVE A HIGHER PRIORITY OVER YOUR OTHER ASSIGNMENTS." DO YOU SEE THAT LANGUAGE?
MR. LEACH: WHY WERE YOU COMMUNICATING THAT TO YOUR TEAM?
SUREKHA GANGAKHEDKAR: BECAUSE THE PRIORITIZATION WAS CONVEYED TO ME BY MS. HOLMES, AND I WAS CONVEYING IT TO THE TEAM SO THEY ARE AWARE THAT THIS PROJECT WILL BE A HIGHER PRIORITY THAN OTHER PROJECTS THAT THEY WERE WORKING ON AT THAT TIME.
MR. LEACH: DID YOU FIND THAT PRIORITIES WITHIN THERANOS WOULD SHIFT OVER TIME?
MR. LEACH: OKAY. WAS THAT A MATTER OF FRUSTRATION TO YOU?
MR. LEACH: HOW SO?
SUREKHA GANGAKHEDKAR: BECAUSE WE WOULD BE, WE WOULD BE LIKE MOVING FROM SEVERAL PROJECTS OVER A MATTER OF TIME AND MANY TIMES WE WOULDN'T HAVE AN OPPORTUNITY TO KIND OF GO AND GET TO, LIKE, THE END RESULT OF IT.
MR. LEACH: THANK YOU, MS. HOLLIMAN. WE CAN TAKE THAT DOCUMENT DOWN. MS. GANGAKHEDKAR, I'D LIKE TO DRAW YOUR ATTENTION TO WHAT WE HAVE MARKED AS EXHIBIT 853, WHICH SHOULD BE THERE IN YOUR BINDER. ARE YOU FAMILIAR WITH THIS DOCUMENT, MS. GANGAKHEDKAR?
MR. LEACH: IS THIS AN EMAIL FROM YOU TO ELIZABETH HOLMES AND OTHERS DATED MAY 1ST, 2013?
MR. LEACH: AND WHY WERE YOU -- DOES THE SUBJECT OF THIS RELATE TO RESULTS AND RUNS ON THE 4S AND OTHER DEVICES DURING THIS TIME PERIOD?
MR. LEACH: AND WERE YOU SENDING THIS TO MS. HOLMES IN ORDER TO KEEP HER APPRISED OF HOW THINGS WERE GOING WITH RESPECT TO VALIDATING ASSAYS ON THE 4S AND OTHER DEVICES?
SUREKHA GANGAKHEDKAR: SO I WOULD THINK THAT BECAUSE THE 4.0'S WERE JUST RELEASED TO US FOR TESTING, THIS WOULD JUST HAVE BEEN LIKE AN EVALUATION PERIOD OF HOW THEY'RE FUNCTIONING, NOT AS MUCH AS THEY'RE NOT VALIDATING AT THIS POINT. IT IS JUST FEASIBILITY OR EVALUATION.
MR. LEACH: WELL, YOU'RE SENDING THIS TO MS. HOLMES TO KEEP HER APPRISED OF HOW THINGS ARE GOING?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 853 INTO EVIDENCE.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 853 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN START WITH THE FIRST EMAIL ON THE CHAIN ON PAGE ONE FROM MR. PANGARKAR. LET'S CAPTURE THE WHOLE TEXT IF WE CAN. PERFECT. THANK YOU.
MR. LEACH: MS. GANGAKHEDKAR, THIS STARTS FROM AN EMAIL FROM CHINMAY PANGARKAR. WHO WAS HE?
SUREKHA GANGAKHEDKAR: HE WAS FIRST LEADING THE DEVELOPMENT OF THE CBC ASSAYS.
MR. LEACH: AND THERE ARE SOME INDIVIDUALS IN THE TO LINE THAT WE HAVEN'T TALKED ABOUT, PAUL PATEL AND SAMARTHA ANEKAL. WHO ARE THEY?
SUREKHA GANGAKHEDKAR: SO PAUL PATEL WAS LEADING THE ASSAYS EFFORTS FOR THE GENERAL CHEMISTRY ASSAY, AND SUMARTHA ANEKAL WAS LEADING THE DEVELOPMENT OF THE 4.0 DEVICES.
MR. LEACH: SO IS MR. PATEL ESSENTIALLY YOUR PEER IN A DIFFERENT ASSAY GROUP?
MR. LEACH: AND MR. ANEKAL HAS RESPONSIBILITY FOR THE DEVICE ITSELF THAT YOU ARE TRYING TO TRANSFER THESE ASSAYS ONTO?
SUREKHA GANGAKHEDKAR: YES, I THINK SO.
MR. LEACH: OKAY. MR. PANGARKAR WRITES IN THE FIRST LINE, "PLEASE FIND BELOW THE REPORTS FOR TODAYS RUNS ON MINI, MONO, AND 4S." WHAT ARE MINI, MONO, AND 4S?
SUREKHA GANGAKHEDKAR: SO I WOULD SAY THAT THEY ARE DIFFERENT VARIATIONS OF THE 4.0 DEVICES.
MR. LEACH: AT THE END OF THAT PARAGRAPH HE WRITES, "THERE WERE MULTIPLE ISSUES DURING THESE RUNS WHICH ARE SUMMARIZED BELOW." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND THEN THERE'S A NUMBER 1, MINILAB 5B RUN. THE FIRST BULLET SAYS, "HEPARIN NANOTAINER HAD BIG BUBBLE UNDERNEATH THE PLUG OF BLOOD." WHAT IS THE NANOTAINER?
SUREKHA GANGAKHEDKAR: SO THE NANOTAINER WAS THE THERANOS PROPRIETARY DEVICE TO COLLECT BLOOD.
MR. LEACH: ESSENTIALLY A BLOOD COLLECTION DEVICE?
MR. LEACH: AND HOW DID THAT COMPARE TO TUBES OR BLOOD COLLECTION DEVICES THAT MIGHT BE USED IN OTHER SETTINGS?
SUREKHA GANGAKHEDKAR: SO THE NANOTAINER WAS A LOW VOLUME COLLECTION DEVICE.
MR. LEACH: AND WHAT DID THAT MEAN TO YOU IT HAD A BIG BUBBLE UNDERNEATH THE PLUG OF BLOOD, WHY WAS THAT AN ISSUE?
SUREKHA GANGAKHEDKAR: SO EITHER IT COULD HAVE -- ESSENTIALLY COULD HAVE NOT COLLECTED THE REQUIRED SAMPLE VOLUME.
MR. LEACH: AND THE NEXT BULLET SAYS, "CARTRIDGE LID OPENING FAILED, IN SPITE OF THE FACT THAT THE SAME CARTRIDGE HAD BEEN QC'ED A FEW MINUTES PRIOR." WHAT DID THAT MEAN?
SUREKHA GANGAKHEDKAR: SO THERE WAS AN ISSUE WITH THE CARTRIDGE LID, SO IN SPITE OF THE CARTRIDGE BEING QC'ED, IT SEEMS LIKE THEY HAVE AN ISSUE WITH THE CARTRIDGE LID OPENING AND IT FAILED.
MR. LEACH: THE NEXT BULLET SAYS, "ROUND VESSELS WERE PICKED UP BY BLOOD TIPS DURING THE RUN." WHY IS THAT AN ISSUE?
SUREKHA GANGAKHEDKAR: I'M NOT VERY FAMILIAR WITH THESE CBC ASSAYS, SO I MIGHT NOT BE ABLE TO GIVE YOU THE EXACT REASON BEHIND THAT PARTICULAR POINT.
MR. LEACH: OKAY. DID YOU HAVE A HIGH LEVEL UNDERSTANDING AT THAT POINT WHY IT MIGHT BE AN ISSUE?
SUREKHA GANGAKHEDKAR: NOT MUCH BECAUSE I WASN'T VERY FAMILIAR WITH WHAT WAS HAPPENING WITH THE OTHER FUNCTIONS. SO APART FROM ONLY READING EMAILS WHERE I WAS COPIED ON, I DIDN'T KNOW ALL OF THE DETAILS OF THE OTHER FUNCTIONS.
MR. LEACH: OKAY. SO THIS RELATES TO CBC, WHICH IS AN ASSAY GROUP THAT YOU'RE NOT RESPONSIBLE FOR, BUT YOU'RE ON THE CHAIN BECAUSE YOU'RE ALSO DEVELOPING ASSAYS FOR THESE DEVICES?
MR. LEACH: OKAY. YOU WRITE AT THE TOP OF IT -- IF WE CAN ZOOM OUT HERE AND GO TO MS. GANGAKHEDKAR'S RESPONSE AT THE TOP. YOU WRITE, "A CONCERN ALSO EXISTS WITH THE BLOOD VOLUMES COLLECTED IN THE NANOTAINER." WHAT WERE YOU GETTING AT THERE?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY I'M CONVEYING THAT THE AMOUNT OF BLOOD THAT IS BEING SELECTED IN THE DEMO RUNS FOR THE NANOTAINER.
MR. LEACH: AND WHY WAS THAT AN ISSUE? WHY WAS THAT A CONCERN?
SUREKHA GANGAKHEDKAR: WELL, IF THERE ISN'T SUFFICIENT BLOOD IN THE NANOTAINER, THEN THERE ISN'T SUFFICIENT VOLUME OF SAMPLE TO TEST FOR THE CARTRIDGE.
MR. LEACH: PRIOR TO YOUR RESIGNATION, DID THIS ISSUE OR OTHER ISSUES WITH THE NANOTAINER EVER GET RESOLVED FROM YOUR POINT OF VIEW?
MR. LEACH: ARE THE ISSUES REPORTED IN EXHIBIT 853 TYPICAL OF SOME OF THE ISSUES THAT YOU WERE SEEING WITH TESTING ON THE 4S?
MR. LEACH: LET ME PLEASE DRAW YOUR ATTENTION TO THE NEXT EXHIBIT, WHICH IS 5084. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU, MS. GANGAKHEDKAR?
MR. LEACH: ARE YOU FAMILIAR WITH THIS DOCUMENT?
MR. LEACH: LET ME DRAW YOUR ATTENTION TO PAGE 2. ON PAGE 2 IS THERE AN EMAIL FROM YOU TO MS. HOLMES, DANIEL YOUNG AND OTHERS WITH THE SUBJECT OF ELISA DATA FOR TODAY?
MR. LEACH: YES. AND ARE YOU UPDATING MS. HOLMES ON ELISA TESTING ON THE 4S IN THE MAY 2013 TIME PERIOD?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 5084 INTO EVIDENCE.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5084 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN GO TO PAGE 2 AND START AT THE TOP OF THE DOCUMENT TO WHERE IT SAYS DEMO DATA IN BOLD. THANK YOU VERY MUCH.
MR. LEACH: ARE YOU ABLE TO SEE IT ON THE SCREEN, MS. GANGAKHEDKAR?
SUREKHA GANGAKHEDKAR: I CAN.
MR. LEACH: I DON'T HAVE IT ON MINE FOR SOME REASON. YOU WRITE ELISA DATA FOR TODAY. WHAT ARE YOU SUMMARIZING FOR MS. HOLMES AND OTHERS HERE?
SUREKHA GANGAKHEDKAR: SO THIS IS THE SUMMARY ON THE 4.0 DEVICE.
MR. LEACH: YOU WROTE CALIBRATION, BULLET "VIT D -- VERY NOISY, CALIBRATION CURVE CANNOT BE GENERATED." WHAT DID YOU MEAN BY THAT?
SUREKHA GANGAKHEDKAR: BASICALLY WE WOULD RUN -- A CALIBRATION CURVE IS A SET OF STANDARDS OF KNOWN CONCENTRATIONS, AND I'M REPORTING BACK THAT WE COULDN'T GET A CALIBRATION CURVE, A SUCCESSFUL CURVE OUT OF THE RUNS ON THE SYSTEM.
MR. LEACH: IS THAT WHAT YOU MEAN BY VERY NOISY?
MR. LEACH: IN THE PARAGRAPH BELOW THAT YOU WROTE, "WE REALLY DON'T HAVE AN UNDERSTANDING OF THE KINETICS OF THIS ASSAY." WAS THAT ACCURATE AT THE TIME?
SUREKHA GANGAKHEDKAR: SO I WOULD LIKE TO ADD IN THIS EMAIL THREAD --
MR. LEACH: SURE.
SUREKHA GANGAKHEDKAR: -- BECAUSE I THINK AT THE TOP OF IT, IT SAYS PLEASE COMMENT ON YOUR READ ON THE ASSAY ISSUES FOR SAM. SO I BELIEVE THAT SOME OF THE COMMENTS IN HERE HAVE BEEN INSERTED BY SAM ON THE EMAIL THAT I HAD SENT.
MR. LEACH: AND IT'S A WONDERFUL POINT. THANK YOU FOR POINTING THAT OUT, MS. GANGAKHEDKAR. SO AT THE TOP OF THE DOCUMENT -- AND IF WE CAN ZOOM OUT, MS. HOLLIMAN. -- YOU'RE REFERRING TO THE TOP WHERE IT SAYS, "PLEASE COMMENT ON YOUR READ ON ROOT CAUSE FOR THESE ISSUES, ELIZABETH?" AND YOU TOOK THAT AS DIRECTION FROM MR. ANEKAL TO MAKE COMMENT ON WHAT YOU WERE REPORTING HERE?
MR. LEACH: AND IF WE CAN GO BACK TO THE BODY, ARE YOU SAYING THAT THE THINGS OUTSIDE OF THE BULLETS ARE MR. ANEKAL'S COMMENTS RESPONSE TO WHAT YOU WERE REPORTING?
MR. LEACH: AND SO THAT'S MR. ANEKAL WRITING, "WE REALLY DON'T HAVE AN UNDERSTANDING OF THE KINETICS OF THIS ASSAY"?
MR. LEACH: OKAY. DID YOU HAVE A VIEW OF THAT ONE WAY OR ANOTHER?
SUREKHA GANGAKHEDKAR: WELL, WE, WE HAD SPENT I THINK LIKE SOME SIGNIFICANT TIME ON THE VITAMIN D ASSAY. IT WAS A VERY CHALLENGING ASSAY TO DEVELOP, BUT, OF COURSE, I THINK MOVING FROM THE 3.0 AND TRYING TO UNDERSTAND HOW THE 4.0 INSTRUMENT WORKS AND THE INHERENT ISSUES OF THE SYSTEM WERE AT THAT POINT UNKNOWN TO US. SO IT WAS ESSENTIALLY WE MIGHT AS WELL BE LOOKING AT LIKE REDEVELOPING THE ASSAYS ON THE 4.0.
MR. LEACH: THANK YOU. IN THE THIRD BULLET -- THAT'S YOU WRITING IN THE BULLET POINTS IN THIS EMAIL; CORRECT?
MR. LEACH: OKAY. YOU WROTE, "TSH, NO RESPONSE, TROUBLESHOOTING ISSUES." WHAT IS TSH?
SUREKHA GANGAKHEDKAR: SO IT IS A PROTEIN TARGET.
MR. LEACH: WHAT DID YOU MEAN BY "NO RESPONSE, TROUBLESHOOTING ISSUES"?
SUREKHA GANGAKHEDKAR: SO WE RAN THE TESTS ON THE 4.0'S, AND WE DID NOT GET ANY RESPONSE?
MR. LEACH: IS THAT GOOD NEWS OR BAD NEWS?
SUREKHA GANGAKHEDKAR: BAD NEWS.
MR. LEACH: IN THE NEXT BULLET YOU WROTE, "7 ERRORS IN 20 RUNS; 2 DUE TO ROUND VESSEL PICK UP; 1 -- COLOR STRIP DROPPED; 4 -- UNKNOWN." WHAT WERE YOU ARE COMMUNICATING THERE?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY SUMMARIZING THE DATA FOR THAT PARTICULAR DAY THAT WE HAD LIKE 20 RUNS, AND THOSE WERE SOME OF THE PROBLEMS THAT WE HAD ENCOUNTERED.
MR. LEACH: IS THIS EXEMPLARY OF SOME OF THE ISSUES THAT YOU WERE OBSERVING IN TRYING TO TRANSFER ASSAYS THAT YOU WERE DEVELOPING ONTO THE 4.0?
MR. LEACH: DID THESE ISSUES EVER GET RESOLVED IN YOUR MIND?
MR. LEACH: LET ME DRAW YOUR ATTENTION TO WHAT WE HAVE MARKED AS 5089. AND IF I COULD DRAW YOUR -- DO YOU HAVE THAT IN FRONT OF YOU, MS. GANGAKHEDKAR?
MR. LEACH: AND LET ME DRAW YOUR ATTENTION TO PAGE 3, PLEASE. DO YOU SEE AN EMAIL FROM ELIZABETH HOLMES TO YOU AND OTHERS WITH THE SUBJECT 11TH?
MR. LEACH: IF YOU COULD GO TO THE NEXT PAGE, PAGE 2. DOWN AT THE BOTTOM ARE YOU FORWARDING MS. HOLMES'S EMAIL TO MEMBERS OF YOUR TEAM IN ORDER TO KEEP THEM APPRISED OF WHAT MS. HOLMES WAS COMMUNICATING TO YOU?
MR. LEACH: AND IS THE REMAINDER OF THIS DOCUMENT DETAILS ABOUT HOW YOUR TEAM IS GOING TO EXECUTE ON THAT DIRECTION?
MR. LEACH: OKAY. DID YOU USE EMAIL IN THE ORDINARY COURSE OF BUSINESS TO COMMUNICATE DIRECTIVES TO YOUR TEAM ABOUT HOW TO DEVELOP ASSAYS AND HOW TO FOLLOW THROUGH ON INSTRUCTIONS FROM MS. HOLMES?
MR. LEACH: AND WERE THOSE PREPARED AT OR NEAR THE TIME BY FOLKS WITHIN YOUR GROUP WITH KNOWLEDGE?
MR. LEACH: AND WERE THESE EMAILS KEPT IN THE REGULAR COURSE OF BUSINESS SO PEOPLE COULD UNDERSTAND WHAT OR HOW PEOPLE WERE EXECUTING ON MS. HOLMES'S DIRECTION?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: WAS IT THE REGULAR PRACTICE FOR YOU AND YOUR TEAM TO PREPARE EMAILS LIKE THIS TO KEEP EACH OTHER APPRISED ABOUT HOW YOU WERE EXECUTING ON MS. HOLMES'S DIRECTION?
MR. LEACH: OKAY. AND DID YOU FEEL THAT YOU WERE UNDER A BUSINESS DUTY TO BE ACCURATE IN THESE EMAILS?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 5089 INTO EVIDENCE.
JUDGE DAVILA: IT'S RECEIVED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5089 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN PLEASE START ON PAGE 3. AND IF WE COULD HIGHLIGHT THE ENTIRETY OF THE TEXT, IF WE COULD, RIGHT DOWN TO THE SIGNATURE LINE. THERE YOU GO. WONDERFUL. THANK YOU.
MR. LEACH: DO YOU SEE ELIZABETH HOLMES'S NAME IN THE FROM LINE?
MR. LEACH: AND THERE'S SOME FOLKS WE HAVEN'T TALKED ABOUT YET, MICHAEL CHEN, CLARISSA LIU, AND PEY-JIUN KO. WHO ARE THEY?
SUREKHA GANGAKHEDKAR: SO MICHAEL CHEN AND CLARISSA LIU WERE RESPONSIBLE FOR DEVELOPING OR PROVIDING THE CARTRIDGES FOR THE 4.0 SYSTEMS. I AM NOT SURE WHO PEY-JIUN KO IS.
MR. LEACH: IN THE CC LINE, IN ADDITION TO MR. BALWANI AND DANIEL YOUNG, THERE'S TWO NAMES, DANIEL EDLIN AND CHRISTIAN HOLMES. WERE YOU FAMILIAR WITH THEM?
MR. LEACH: AND WHO WERE THEY?
SUREKHA GANGAKHEDKAR: SO CHRISTIAN HOLMES WAS LEADING THE PROJECT -- A GROUP OF PROJECT MANAGERS, AND DANIEL EDLIN WAS ONE OF THE PROJECT MANAGERS.
MR. LEACH: DO YOU SEE THERE'S A LINE IN THE EMAIL HEADER IMPORTANCE HIGH?
MR. LEACH: AND WHAT DID THAT MEAN TO YOU?
SUREKHA GANGAKHEDKAR: SO THAT MEANS THAT IT IS A HIGHER PRIORITY PROJECT OR ACTIVITY THAN THE OTHER WORK THAT WE WERE DOING.
MR. LEACH: MS. HOLMES WRITES, "THIS IS THE MOST IMPORTANT PRIORITY ABOVE ALL ELSE FOR THIS WEEK. "CHINMAY, PAUL, SUREKHA: PLEASE ASSIGN ALL MEMBERS OF YOUR TEAM WHO CAN CONTRIBUTE TO THIS INITIATIVE; THIS IS THE ONLY THING THOSE TEAM MEMBERS SHOULD FOCUS ON UNTIL THE DEMO IS COMPLETE." WHAT DID THAT MEAN, "THE DEMO"?
SUREKHA GANGAKHEDKAR: SO IT WAS A DEMO TO SHOW HOW THE 4.0 WORKED.
MR. LEACH: SITTING HERE TODAY DO YOU HAVE A MEMORY OF WHO THE DEMO WAS FOR?
SUREKHA GANGAKHEDKAR: NO. USUALLY THAT INFORMATION WAS NOT RELEASED.
MR. LEACH: OKAY. IN THE FOURTH PARAGRAPH IT SAYS, "AS DISCUSSED, THE TARGET IS TO RUN MINILAB (BLADES) -- OMNIPLEX, BUT POTENTIALLY SPLITTING CBC, ELISA, AND GC AS NEEDED." CAN YOU TRANSLATE FOR US? WHAT DOES THAT MEAN TO YOU?
SUREKHA GANGAKHEDKAR: SO THE OMNIPLEX IS A SINGLE CARTRIDGE THAT COULD RUN THE THREE TYPES OF ASSAYS LISTED HERE, CBC, ELISA, AND GC.
MR. LEACH: GC IS AN ACRONYM FOR GENERAL CHEMISTRY. WE NEED TO SPEAK ONE AT A TIME, MS. GANGAKHEDKAR, AND I'LL DO MY BEST TO DO THAT. IS GC AN ACRONYM FOR GENERAL CHEMISTRY?
MR. LEACH: AND CBC, WHAT DOES THAT STAND FOR?
SUREKHA GANGAKHEDKAR: COMPLETE BLOOD COUNT.
MR. LEACH: THANK YOU. AND WHEN MS. HOLMES SAYS THE TARGET IS TO RUN MINILAB, WHAT DID YOU TAKE THAT TO MEAN?
SUREKHA GANGAKHEDKAR: SO THAT IS A VERSION OF THE 4.0.
MR. LEACH: AND IS THAT THE VERSION THAT YOU UNDERSTOOD WAS TO BE THE TARGET FOR THE DEMO?
MR. LEACH: THE NEXT LINE SAYS "SECONDARY/ADDITIONAL TARGET IS TO RUN THE 4S." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHAT DOES THAT MEAN, "SECONDARY/ADDITIONAL TARGET"?
SUREKHA GANGAKHEDKAR: SO THERE WERE DIFFERENT CONFIGURATIONS OF THE 4.0 DEVICES. ONE OF THEM WAS 4S. THE OTHER ONE WAS CALLED THE MINILAB.
MR. LEACH: AND WHEN THAT'S THE SECONDARY OR ADDITIONAL TARGET, WHAT DID THAT MEAN TO YOU?
SUREKHA GANGAKHEDKAR: I'M SORRY, I CAN'T ANSWER THAT BECAUSE I DON'T EXACTLY RECOLLECT WHAT THE DIFFERENCES BETWEEN THE VERSIONS WERE.
MR. LEACH: OKAY. THE NEXT LINE SAYS, "AS BACKUP, THE MANUAL PROCESS SHOULD BE FLAWLESS AND RELIABLE." WHAT DID YOU UNDERSTAND THE MANUAL PROCESS TO BE?
SUREKHA GANGAKHEDKAR: MY UNDERSTANDING FOR THE MANUAL PROCESS MEANS -- BECAUSE FOR THE ELISA'S WE DID HAVE THE ASSAYS ON THE 4.0'S, AND SO PERHAPS FOR THE CBC AND GENERAL CHEMISTRY ASSAYS THEY WERE TESTING THE SAMPLES IN A DIFFERENT METHOD, WHICH IS A MANUAL PROCESS.
MR. LEACH: DID YOU TAKE THIS AS DIRECTION TO BE TRY THE MINILAB FIRST, IF NOT, THE 4S, AND THEN AS A BACKUP THE MANUAL PROCESS? IS THAT HOW YOU UNDERSTOOD THIS?
SUREKHA GANGAKHEDKAR: I WOULD THINK SO.
MR. LEACH: THAT LAST LINE IS "BCD'S NEED TO BE FLAWLESS." WHAT DOES BCD MEAN?
SUREKHA GANGAKHEDKAR: SO THOSE ARE THE BLOOD COLLECTION DEVICES.
MR. LEACH: AND ONE OF THOSE IS THE NANOTAINER?
MR. LEACH: OKAY. IF WE CAN STRADDLE PAGE 2 AND PAGE 3 WITH THE EMAIL FROM MS. GANGAKHEDKAR. THERE'S A WAY, MS. HOLLIMAN, TO SHOW THE BOTTOM OF PAGE 2 AND THE TOP OF PAGE 3 AT THE SAME TIME. WHY DON'T WE START THERE, MS. HOLLIMAN, AND EXPAND THE BOTTOM HALF OF THIS EMAIL. I'M SORRY, IF WE CAN ALSO GET THE NAMES JUST BENEATH THE SEND DATED. WONDERFUL. THANK YOU. MS. GANGAKHEDKAR, YOU FORWARDED THIS TO SOME INDIVIDUALS, KAREN SHAW AND OTHERS. I JUST WANT -- COULD YOU JUST WALK US THROUGH WHO THE INDIVIDUALS ARE IN THE TO LINE?
SUREKHA GANGAKHEDKAR: SURE. SO KAREN SHAW WAS AN ASSAY DEVELOPER IN THE ELISA TEAM; THE SAME FOR NAHAL GHARAATI; MICHELLE JOHNSON WERE SENIOR SCIENTISTS OR ASSAY DEVELOPERS; SHARADA SIVARAMAN AND TINA NOYES WERE THE TEAM LEADS IN THE ELISA GROUP; AND, ESTER CHEN WAS RESPONSIBLE FOR THE FORMULATIONS AND CARTRIDGE BUILDS.
MR. LEACH: MS. SHAW IS REPORTING AT THE END OF THE NEXT EMAIL, "MAIN BOTTLENECK I IMAGINE WILL BE NUMBER OF READERS AND WHAT TIME THEY ARE RELEASED FROM QC EACH DAY. HOPEFULLY THEY CAN GET MORE GOING SO WE CAN RUN ASAP AND FIND OUT IF ANYTHING NEEDS TWEAKING." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHAT DID YOU UNDERSTAND THAT TO MEAN?
SUREKHA GANGAKHEDKAR: SO THE AVAILABILITY OF THE NUMBER OF READERS TO DO ANY KIND OF DEVELOPMENT OR TESTING WAS ALWAYS A GAP. SO DEPENDING UPON HOW MANY WORKING READERS WERE AVAILABLE TO THE DEVELOPMENT TEAMS, WE HAD TO PLAN OUR DAY AROUND THAT.
MR. LEACH: A READER IS A REFERENCE TO A DEVICE?
SUREKHA GANGAKHEDKAR: YES, SO ESSENTIALLY THE 4.0 DEVICES.
MR. LEACH: OKAY. IF WE CAN ZOOM OUT, PLEASE, MS. HOLLIMAN, AND THEN GO TO TINA NOYES'S EMAIL AT THE TOP OF THIS PAGE. MS. GANGAKHEDKAR, MS. NOYES IS WRITING TO THE GROUP HERE, "WELL THE LAST TIME WE RAN THE OMNI, THE DATA WAS PRETTY TERRIBLE. TSH GAVE DARK COUNTS FOR A WHILE AND THEN MAGICALLY STARTED WORKING AGAIN." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHAT ARE DARK COUNTS?
SUREKHA GANGAKHEDKAR: BASICALLY BACKGROUND COUNTS, SO THERE'S NO RESPONSE AVAILABLE, NO SIGNAL.
MR. LEACH: AND IS THIS EXEMPLARY OF SOME OF THE ISSUES YOU AND YOUR TEAM WERE EXPERIENCING WITH THE NEXT GENERATION OF THERANOS DEVICES?
MR. LEACH: DID THESE EVER GET RESOLVED BEFORE YOU RESIGNED?
MR. LEACH: SO THIS EMAIL -- WE CAN TAKE THIS DOWN, MS. HOLLIMAN, THANK YOU. WE'RE IN JULY OF 2015, MS. GANGAKHEDKAR. IN OR AROUND THE MIDDLE OR LATE JULY OF 2013, DID YOU GO ON A VACATION?
MR. LEACH: AND WHERE DID YOU GO?
SUREKHA GANGAKHEDKAR: I WENT TO INDIA.
MR. LEACH: HOW LONG WERE YOU THERE FOR?
SUREKHA GANGAKHEDKAR: SO I WENT FROM I THINK THE 21ST OF JULY AND CAME BACK AROUND THE 17TH OF AUGUST.
MR. LEACH: OKAY. AT THE TIME THAT YOU LEFT FOR YOUR VACATION, HOW WOULD YOU DESCRIBE THE STATUS OF YOUR WORK? WHAT WERE YOU -- WHAT DID YOU UNDERSTAND THE PRIORITY OR THE PLAN IN TERMS OF YOUR ASSAY DEVELOPMENT?
SUREKHA GANGAKHEDKAR: SO TWO PATHWAYS. ESSENTIALLY CONTINUING TO DEVELOP THE ASSAYS FROM THE PRIORITY LIST THAT WAS GIVEN TO US ON THE EDISON 3.0'S AND ALSO HAD A SMALL TEAM OF THE GROUP, A SMALL GROUP OF WORKING ON BRINGING UP THE 4.0'S. THAT ESSENTIALLY MEANT TESTING THE ASSAYS ON THE 4.0'S.
MR. LEACH: WERE YOU AWARE OF ANY PLAN TO LAUNCH AT WALGREENS IMMINENTLY WHEN YOU LEFT ON YOUR VACATION?
SUREKHA GANGAKHEDKAR: I WAS NOT.
MR. LEACH: WERE YOU AWARE OF ANY PLAN TO GO LIVE WITH THERANOS DEVICES IN THE CLIA LAB BEFORE YOU WENT ON VACATION?
SUREKHA GANGAKHEDKAR: I WAS NOT.
MR. LEACH: WERE YOU AWARE OF ANY PLAN TO MODIFY THIRD PARTY DEVICES SUCH AS SIEMENS MACHINES FOR USE IN THE CLIA LAB?
SUREKHA GANGAKHEDKAR: NOT AT THAT TIME.
MR. LEACH: AND WHEN YOU COME BACK IN THE MIDDLE OF AUGUST OF 2013, WHAT DID YOU LEARN?
SUREKHA GANGAKHEDKAR: THAT WE WERE LAUNCHING ASSAYS TO USE ON PATIENT SAMPLES.
MR. LEACH: OKAY. AND WERE YOU SURPRISED BY THAT?
MR. LEACH: WHY WERE YOU SURPRISED?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE I DIDN'T THINK THAT THE 3.0 DEVICES WERE READY TO BE USED FOR PATIENT SAMPLES.
MR. LEACH: WHEN YOU SAY YOU DIDN'T THINK THAT THE 3.0'S WERE READY FOR USE ON PATIENT SAMPLES, DOES THAT INCLUDE THE 3.5'S?
MR. LEACH: WHY DID YOU BELIEVE THE 3.0'S AND THE 3.5'S WERE NOT READY FOR USE ON THE PATIENT SAMPLES?
SUREKHA GANGAKHEDKAR: BECAUSE WE WERE AWARE THAT THERE WERE RELIABILITY ISSUES WITH THE EDISON 3.0'S, AND AT THAT TIME THEY WERE NOT FULLY RESOLVED.
MR. LEACH: WHEN YOU SAY, "WE WERE AWARE," DID YOU HAVE DISCUSSIONS PRIOR TO THE MIDDLE OF AUGUST WITH MS. HOLMES ABOUT THOSE ISSUES?
SUREKHA GANGAKHEDKAR: SO SHE, SHE WAS -- IN MY OPINION SHE WAS AWARE BECAUSE THAT WAS A STOPGAP METHOD TO USE UNTIL THE 4.0 DEVICES WOULD BE AVAILABLE FOR DEVELOPMENT.
MR. LEACH: AND WHEN YOU SAY THAT THE 3.0 AND THE 3.5 HAD RELIABILITY ISSUES, WHAT DO YOU MEAN? WHAT WERE THE ISSUES?
SUREKHA GANGAKHEDKAR: SO THERE WERE LIKE PROBLEMS IN GIVING CONSISTENT RESULTS. EITHER THEY WOULD HAVE I THINK PROBLEMS WITH THE RESPONSES AND RESULTS SUCH AS EITHER VERY LOW COUNTS OR VERY HIGH COUNTS AND THERE COULD BE PROBLEMS WITH THE PICKUP OF THE REAGENTS OR THE REACTION TIPS IN A RUN.
MR. LEACH: PRIOR TO THE MIDDLE OF AUGUST, HAD YOU BEEN IN MEETINGS WITH MS. HOLMES WHERE SOME OF THESE ISSUES WERE DISCUSSED?
MR. LEACH: WHEN YOU CAME BACK FROM YOUR VACATION IN THE MIDDLE OF AUGUST OF 2013, DID YOU ALSO LEARN OF A PLAN TO MODIFY SIEMENS MACHINES?
MR. LEACH: AND WHAT DID YOU LEARN?
SUREKHA GANGAKHEDKAR: SO I, I LEARNED THROUGH THE EMAILS THAT THEY WERE LOOKING AT MODIFYING THE PROTOCOLS OF THE SIEMENS MACHINES TO BE ABLE TO USE LOWER SAMPLES OR DILUTED SAMPLES.
MR. LEACH: BETWEEN LATE AUGUST OF 2013 AND THE TIME OF YOUR RESIGNATION, DID YOU FEEL PRESSURE TO VALIDATE ASSAYS FOR USE IN THE CLIA LAB?
MR. LEACH: WAS THAT PRESSURE OUTSIDE OF THE NORMAL COURSE OF BUSINESS OR WAS THIS SOMETHING USUAL? HOW WOULD YOU DESCRIBE IT?
SUREKHA GANGAKHEDKAR: SO IT WAS THE USUAL BECAUSE EVEN THROUGH THE PAST EXPERIENCES MANY TIMES THERE WOULD BE THESE NEW PROJECTS, PRIORITY DEMOS, THAT WE HAD TO DELIVER UPON. BUT WITH THIS LAUNCH THAT IT SEEMED LIKE IT WAS IMMINENT, AND SO THERE WAS INCREASINGLY MORE PRESSURE ON GETTING THE STUDIES COMPLETED.
MR. LEACH: AND WHERE WAS THIS PRESSURE COMING FROM?
SUREKHA GANGAKHEDKAR: FROM MS. HOLMES.
MR. LEACH: DID YOU FEEL AS IF THE VALIDATION WAS BEING RUSHED?
MR. LEACH: AND WHY DO YOU SAY THAT?
SUREKHA GANGAKHEDKAR: BECAUSE OF THE AMOUNT OF TIME THAT WE HAD AT THE TIME OF THE LAUNCH AND WHERE WE WERE WITH THE 3.0 DEVICES GIVEN THAT THEY WERE AWARE THAT THERE WERE ISSUES WITH 3.0'S, SO THEY WERE LOOKING TO UPGRADE SOME OF THOSE ISSUES AND CAUSE -- THEY WERE LOOKING TO UPGRADE SOME OF THOSE 3.0 DEVICES INTO A NEW VERSION CALLED 3.5.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO SOME DOCUMENTS FROM THIS TIME PERIOD, AUGUST OF 2013, MS. GANGAKHEDKAR. IF YOU COULD PLEASE LOOK IN YOUR BINDER AT EXHIBIT 5338. DO YOU HAVE THAT IN FRONT OF YOU?
MR. LEACH: AND DO YOU RECOGNIZE THIS AS AN EMAIL FROM SHARADA SIVARAMAN TO DANIEL YOUNG WITH A COPY TO YOU?
MR. LEACH: AND DO YOU BELIEVE THAT THIS WAS SENT DURING THE TIMEFRAME OF YOUR VACATION?
MR. LEACH: AND WHILE YOU WERE ON VACATION, DID SOMEBODY STAND IN FOR YOU OR ASSUME YOUR RESPONSIBILITIES AS THE MANAGER OF ASSAY SYSTEMS?
MR. LEACH: AND WHO WAS THAT?
SUREKHA GANGAKHEDKAR: SHARADA SIVARAMAN.
MR. LEACH: SO SHE WAS ESSENTIALLY STANDING IN YOUR SHOES?
MR. LEACH: OKAY. AND PART OF THAT RESPONSIBILITY WAS REPORTING TO MS. HOLMES ABOUT WHERE THINGS WERE IN TERMS OF GETTING THESE ASSAYS VALIDATED?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 5338.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5338 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: IF WE CAN PLEASE ZOOM IN ON THE FIRST HALF OF THIS CAPTURING BULLET 4. THAT'S WONDERFUL.
MR. LEACH: I DRAW YOUR ATTENTION TO THE TOP PART OF THIS EMAIL. DO YOU SEE WHERE IT SAYS PLAN FOR ELISA LDT VALIDATION?
MR. LEACH: AND WHAT DOES LDT MEAN?
SUREKHA GANGAKHEDKAR: IT STANDS FOR LABORATORY DEVELOPED TEST.
MR. LEACH: AND WHAT DOES THAT MEAN IN THE CONTEXT OF THIS EMAIL?
SUREKHA GANGAKHEDKAR: SO IT SEEMS THAT THIS IS A PLAN TO DEVELOP THE ELISA'S OR RATHER CONDUCT THE VALIDATION OF THE ELISA'S THAT THEY HAD DEVELOPED AT THERANOS AS AN LDT.
MR. LEACH: AND LDT TO BE USED IN THE THERANOS CLIA LAB?
SUREKHA GANGAKHEDKAR: AND/OR WITH THE EDISON SYSTEMS.
MR. LEACH: OKAY. MS. SIVARAMAN IS WRITING, "HI DANIEL, PLEASE FIND ATTACHED THE VALIDATION PLAN FOR THE 6 ASSAYS IN A CARTRIDGE SUMMARY FORMAT. ALSO ATTACHED IS THE LDT VALIDATION PLAN WORD DOCUMENT FOR TSH THAT ARNE HELPED DEVELOP IN 2011." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHO IS ARNE?
SUREKHA GANGAKHEDKAR: ARNE, DR. ARNE WAS THE CLIA LAB DIRECTOR AT THAT TIME IN 2011.
MR. LEACH: OKAY. WAS HE THE LAB DIRECTOR AT OR AROUND THE TIME OF THE EMAIL?
MR. LEACH: AND THE LDT VALIDATION PLAN. WHAT IS THAT?
SUREKHA GANGAKHEDKAR: SO, SO WE WERE -- IN PLANNING FOR AN EVENTUAL VALIDATION STUDY FOR THE ASSAY TSH, WE HAD WORKED WITH ARNE IN GENERATING THE VALIDATION PLAN AND WHAT IT WOULD LOOK LIKE.
MR. LEACH: SO THE HOPE IS TO VALIDATE THIS ASSAY FOR USE IN THE CLIA LAB AND YOU PUT TOGETHER -- OR YOUR GROUP HAS PUT TOGETHER A PLAN FOR HOW TO ACHIEVE THAT?
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION TO PARAGRAPH NUMBER 3 WHERE IT SAYS, "THE TOTAL NUMBER OF DEVICES WILL DRIVE THE TIMELINES FOR THE EXERCISE, IT WOULD BE GOOD IF WE CAN GET AN ESTIMATE OF THIS IN ADVANCE. SAM TOLD ME TODAY WE SHOULD HAVE 60, 3.5 DEVICES AVAILABLE BY 8/15. I HAVE ONLY PLANNED OUT THE EXERCISE WITH 3 READERS." WHAT IS THAT PARAGRAPH GETTING AT?
SUREKHA GANGAKHEDKAR: SO ESSENTIALLY THERE'S A SHORTAGE OF READERS AVAILABLE SO THE 3.5 DEVICES WOULDN'T BE AVAILABLE UNTIL THE 15TH.
MR. LEACH: SO ONE OF THE LIMITS YOU ARE RUNNING UP AGAINST IS SIMPLY THE AVAILABILITY OF DEVICES TO RUN YOUR VALIDATION WORK?
MR. LEACH: IF WE CAN NOW GO TO THE BOTTOM HALF OF THE EMAIL, MS. HOLLIMAN. MS. GANGAKHEDKAR, I'M DRAWING YOUR ATTENTION TO PARAGRAPH 6 WHERE IT SAYS, "ECO OF DOCUMENTATION: ESTHER AND THE MFG TEAM ARE GETTING READY WITH TIP COATING, REAGENT FORMULATION, AND ANTIBODY CONJUGATIONS FOR THE VALIDATION." CAN YOU HELP US UNDERSTAND WHAT THAT MEANS.
SUREKHA GANGAKHEDKAR: SO THESE ARE ALL OF THE COMPONENTS OF THE CARTRIDGES, ESSENTIALLY THE TIPS, THE REACTION TIPS, THE REAGENTS, AND THE ANTIBODY CONJUGATIONS THAT ARE USED FOR THE TEST IN A CARTRIDGE. SO I BELIEVE SHARADA IS SUMMARIZING THAT THE MANUFACTURING TEAM IS GETTING READY TO ENSURE THAT ALL OF THE COMPONENTS ARE READY.
MR. LEACH: MS. SIVARAMAN THEN WROTE, "UNTIL WE HAVE THE DOCUMENTATION SQUARED AWAY WE WILL NOT BE ABLE TO START FORMULATIONS SINCE EVERY STEP OF REAGENT PREPARATION WILL NEED TO BE PER A DOCUMENT." WHAT DID THAT MEAN?
SUREKHA GANGAKHEDKAR: SO BEFORE THEY CAN START ANY OF THE PREP WORK FOR THE REAGENTS, THEY NEED TO MAKE SURE THAT ALL OF THE APPROPRIATE PROTOCOLS FOR THE REAGENT PREP AND QC'S AND MANUFACTURING NEED TO BE IN PLACE.
MR. LEACH: AND WAS THAT ANOTHER HOLDUP FOR GETTING THE VALIDATION WORK DONE?
MR. LEACH: THANK YOU. WE CAN TAKE THAT DOWN, MS. HOLLIMAN. I'D LIKE TO DRAW YOUR ATTENTION, MS. GANGAKHEDKAR, TO EXHIBIT 5096. ARE YOU FAMILIAR WITH THIS DOCUMENT?
MR. LEACH: IS THIS ANOTHER EMAIL FROM MS. SIVARAMAN WHEN YOU WERE OUT ON VACATION?
MR. LEACH: WHERE SHE WAS ESSENTIALLY STANDING IN YOUR SHOES AS MANAGER OF ASSAY SYSTEMS?
MR. LEACH: AND DO YOU BELIEVE THAT SHE IS PASSING ON TO YOUR GROUP DIRECTIONS SHE RECEIVED FROM MS. HOLMES AND DR. YOUNG ABOUT THE VALIDATION WORK THAT IS GOING ON IN THIS TIME PERIOD?
MR. LEACH: YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 5096 INTO EVIDENCE.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5096 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN PLEASE ENLARGE THE SUBSTANCE OF THE EMAIL AND THE HEADER. WE'LL START WITH THE TOP HALF.
MR. LEACH: DO YOU SEE YOUR NAME IN THE CC LINE, MS. GANGAKHEDKAR?
MR. LEACH: AND IS THIS TO MEMBERS OF THE ELISA ASSAY DEVELOPMENT GROUP?
MR. LEACH: AND MS. SIVARAMAN IS WRITING, "UPDATE FROM MEETING. 1. THE LDT VALIDATION WILL BE THE TOP PRIORITY FOR THE GROUP FOR NOW." WHAT DOES THAT MEAN?
SUREKHA GANGAKHEDKAR: SO THIS IS LETTING THE GROUP KNOW THAT THIS WILL BE THE HIGHEST PRIORITY FOR NOW.
MR. LEACH: AND WHAT DOES LDT VALIDATION REFER TO?
SUREKHA GANGAKHEDKAR: SO THAT'S THE LABORATORY DEVELOPED TEST VALIDATION.
MR. LEACH: GETTING TESTS VALIDATED ON THE 3.0 AND THE 3.5 FOR USE IN THE CLIA LAB?
MR. LEACH: NUMBER 2 IT SAYS, "RETAIL, DOD ANIMAL AND WALTER REED ASSAYS TO BE ON THE BACK BURNER FOR NOW." WHAT DID YOU UNDERSTAND THAT TO MEAN?
SUREKHA GANGAKHEDKAR: SO THERE WERE OTHER ASSAY DEVELOPMENT PROJECTS THAT THE TEAM MEMBERS WERE WORKING ON, AND I THINK THOSE ARE THE ONES THAT ARE LISTED, ESSENTIALLY TELLING THE TEAM THAT ALL OF OUR FOCUS SHOULD BE ON THE LDT VALIDATION AND NOT THE OTHER DEVELOPMENT PROJECTS.
MR. LEACH: THANK YOU. WE CAN TAKE THAT DOCUMENT DOWN, MS. HOLLIMAN. AND I'D LIKE TO DRAW YOUR ATTENTION TO EXHIBIT 5100. IF I COULD DRAW YOUR ATTENTION -- DO YOU HAVE THAT IN FRONT OF YOU?
MR. LEACH: AND COULD I DRAW YOUR ATTENTION, PLEASE, TO PAGE 2. DO YOU SEE AN EMAIL FROM MS. SIVARAMAN TO YOU, SUNNY BALWANI, ELIZABETH HOLMES, AND OTHERS ON AUGUST 14TH, 2013?
MR. LEACH: AND IS THIS ALSO AT A TIME WHEN YOU WERE OUT ON VACATION AND MS. SIVARAMAN IS STANDING IN YOUR SHOES?
MR. LEACH: OKAY. YOUR HONOR, THE GOVERNMENT MOVES FOR THE ADMISSION OF EXHIBIT 5100.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5100 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: IF WE COULD GO TO PAGE 2, PLEASE, MS. HOLLIMAN, AND ZOOM IN ON THE SUBSTANCE OF THE EMAIL. PERFECT.
MR. LEACH: DO YOU SEE MS. HOLMES'S NAME IN THE TO LINE, MS. GANGAKHEDKAR?
MR. LEACH: OKAY. AND IN THE FIRST PARAGRAPH IT SAYS, "PLEASE SEE BELOW FOR 3.5 DATA SO FAR ON THE CARTRIDGES THAT WERE ASSEMBLED YESTERDAY EVENING WITH THE NEWLY CUT CAPTURE LAYERS AND WICKING PADS." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND WHAT DO YOU UNDERSTAND THE PURPOSE OF THIS EMAIL TO BE?
SUREKHA GANGAKHEDKAR: SO I BELIEVE, LIKE, SHARADA IS UPDATING THE RECIPIENTS ON THE STATUS OF THE TESTS THAT WERE CONDUCTED ON THE 3.5 DEVICES.
MR. LEACH: OKAY. IN THE THIRD FULL PARAGRAPH IT SAYS, "IT LOOKS LIKE THE NEWLY CUT PARTS MAY BE HELPING, BUT WE ARE STILL SEEING THE LOW OUTLIERS THAT ARE GIVING RISE TO 30 TO 60 PERCENT INTRA CV'S AND WE ARE ALSO SEEING HIGHER INTER SERVICE." SO WHAT IS CV?
SUREKHA GANGAKHEDKAR: SO IT'S THE COEFFICIENT OF VARIATION.
MR. LEACH: AND WAS IT GOOD NEWS OR BAD NEWS OR INDIFFERENT NEWS THAT OUTLIERS ARE GIVING RISE TO 30 TO 60 PERCENT INTRA CV'S AND YOU'RE ALSO SEEING HIGHER INTER SERVICE?
SUREKHA GANGAKHEDKAR: IT'S BAD NEWS.
MR. LEACH: FURTHER DOWN COUNSEL AT THE BOTTOM IT SAYS, "MORE CARTRIDGES WILL NEED TO BE BUILT FOR THIS AND I WANTED TO KNOW IF WE CAN HAVE MORE OF THESE PADS CUT AT LEAST FOR 24 MORE." DO I UNDERSTAND THAT TO MEAN THAT THERANOS IS MAKING THE CARTRIDGES AS IT'S DOING THIS VALIDATION WORK?
MR. LEACH: AND YOU WEREN'T JUST GRABBING THEM OFF THE SHELF AND USING THEM FOR WHAT YOU WERE DOING?
SUREKHA GANGAKHEDKAR: AT LEAST FROM THIS PARTICULAR LINE IT SAYS THAT THE WORK WAS KIND OF DEPENDENT UPON WHEN THE CARTRIDGES WOULD BE AVAILABLE.
MR. LEACH: OKAY. LET'S GO TO THE NEXT -- LET'S GO TO PAGE 1. AND IF WE CAN ZOOM IN TO THE TOP PORTION. DO YOU SEE ANOTHER EMAIL FROM MS. SIVARAMAN ON THE NEXT DAY REPORTING ON ADDITIONAL RUNS ON THE 3.5?
MR. LEACH: OKAY. AND SHE WROTE, "PLEASE SEE ATTACHED. WE'RE STILL SEEING SOME HIGHS CV." DO YOU SEE THAT?
MR. LEACH: AND IS A HIGH CV DESIRABLE FOR ASSAY DEVELOPMENT?
SUREKHA GANGAKHEDKAR: ABSOLUTELY NOT.
MR. LEACH: LET ME MOVE FORWARD IN TIME PLEASE TO EXHIBIT 3967, AND I BELIEVE THIS ONE WE'RE STIPULATING TO.
MR. LEACH: 3967.
JUDGE DAVILA: ARE YOU OFFERING THIS?
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3967 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: LET ME DRAW YOUR ATTENTION, MS. GANGAKHEDKAR, TO THE LOWER PORTION OF THE FIRST PAGE THERE'S AN EMAIL FROM DANIEL YOUNG ON AUGUST 19TH TO YOU AND MS. SIVARAMAN, AND THE SUBJECT IS ASSAYS FOR LAUNCH. DO YOU SEE THAT?
MR. LEACH: AND DID YOU UNDERSTAND LAUNCH TO BE A REFERENCE TO THE WALGREENS LAUNCH?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: AND DANIEL YOUNG IS WRITING, "HI SHARADA, BELOW ARE THE TOP PRIORITY ASSAYS (N EQUALS 63) TO VALIDATE ON EDISON DEVICES FOR LAUNCH." N63, WHAT DOES THAT MEAN?
SUREKHA GANGAKHEDKAR: SO THAT MEANS 63 ASSAYS TO VALIDATE ON THE EDISONS.
MR. LEACH: OKAY. AND IF WE CAN PLEASE GO TO PAGE 3. AND DOWN TOWARDS THE BOTTOM IT READS, "THESE ARE CURRENTLY PLANNED TO BE BROUGHT UP INITIALLY ON THE ADVIA, NOT ON THE EDISON DEVICES?" DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND DOES THAT -- WHAT DID YOU UNDERSTAND THAT TO MEAN?
SUREKHA GANGAKHEDKAR: SO THESE -- THE VALIDATIONS ARE FOR THESE ASSAYS WOULD BE HAPPENING ON THE COMMERCIAL SYSTEM, THE ADVIA.
MR. LEACH: OKAY. AND SO AT THIS POINT IN TIME, AUGUST 19TH OF 2013, THE PLAN IS TO VALIDATE 63 ON THE EDISON AND SOME REMAINDER ON THE MODIFIED SIEMENS MACHINES?
MR. LEACH: FOR USE IN THE CLIA LAB?
MR. LEACH: LET ME DRAW YOUR ATTENTION TO EXHIBIT 1020. YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 1020 INTO EVIDENCE, AND I UNDERSTAND WE AGREE ON THIS.
JUDGE DAVILA: ALL RIGHT. THANK YOU. IT'S RECEIVED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1020 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: IF WE CAN PLEASE LOOK AT THE TOP TWO EMAILS IN THE CHAIN ENDING WITH SHARADA'S SIGNATURE.
MR. LEACH: MS. GANGAKHEDKAR, IN THE SECOND EMAIL TO THE BOTTOM, MS. SIVARAMAN SEEMS TO BE WRITING TO SURAJ SAKSENA AND DANIEL EDLIN. WHO IS SURAJ SAKSENA?
SUREKHA GANGAKHEDKAR: SO SURAJ SAKSENA WAS LEADING THE TEAM WHO WAS DEVELOPING SOME IN-HOUSE REAGENTS FOR THERANOS.
MR. LEACH: AND MS. SIVARAMAN WRITES, "IN OUR MEETINGS RE: THE ELISA LAUNCH AND PREPARATION FOR THE LDT VALIDATION, EAH HAS MENTIONED THIS WILL BE THE ONLY PRIORITY OF THE ENTIRE ELISA TEAM MOVING FORWARD. "WE HAVE 61 ASSAYS TO VALIDATE ON THE 3.X AND 27 ON THE SIEMENS ADVIA." FIRST OF ALL, EAH, IS THAT AN ACRONYM FOR MS. HOLMES?
MR. LEACH: AND 3.X, IS THAT A REFERENCE TO THE 3.0'S AND THE 3.5'S?
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO EXHIBIT 1019. DO YOU HAVE THAT IN FRONT OF YOU?
MR. LEACH: OKAY. IS THIS AN EMAIL FROM YOU TO THE -- AN EMAIL ADDRESS FOR THE ELISA GROUP?
MR. LEACH: AND DO YOU SEE THAT IN THE TO LINE E-L-I-S-A?
MR. LEACH: AND WHAT IS THAT?
SUREKHA GANGAKHEDKAR: ESSENTIALLY THAT WAS AN EMAIL GROUP FOR THE ENTIRE TIME, THE ELISA TEAM.
MR. LEACH: AND DID YOU SEND THIS TO YOUR ELISA TEAM IN ORDER TO UPDATE THEM ON THE CURRENT VALIDATION PLANS FOR THE WALGREENS LAUNCH?
MR. LEACH: AND DID YOU SEND THIS IN THE ORDINARY COURSE OF BUSINESS?
MR. LEACH: AND IS IT BASED ON INFORMATION AT OR NEAR THE TIME THAT THESE PLANS WERE PUT IN PLACE?
MR. LEACH: AND WAS IT YOUR REGULAR PRACTICE TO DISTRIBUTE DIRECTIVES LIKE THIS TO YOUR TEAM PASSING ON PLANS FOR MS. HOLMES?
SUREKHA GANGAKHEDKAR: IT WAS.
MR. LEACH: OKAY. YOUR HONOR, THE GOVERNMENT MOVES FOR THE ADMISSION OF EXHIBIT 1019.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1019 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN ZOOM IN ON THE SECOND EMAIL FROM THE TOP, THE ONE FROM MS. GANGAKHEDKAR. I'M SORRY, THE SECOND ONE. THE ONE BELOW THAT. WONDERFUL. THANK YOU.
MR. LEACH: THE SUBJECT IS VALIDATION PLANS. DO YOU SEE THAT?
MR. LEACH: AND WHAT WERE YOU REFERRING TO?
SUREKHA GANGAKHEDKAR: I WAS REFERRING TO THE PLANNING FOR THE LDT, THE UPCOMING LDT VALIDATION PLANS.
MR. LEACH: AND YOU WROTE, "IN PREPARING FOR THE UPCOMING VALIDATION, PLEASE SEE THE ATTACHED LIST OF ASSAYS THAT WE WILL BE STARTING WITH AND THE ASSIGNMENTS. VALIDATION WILL START IN PHASES AND WILL DEPEND UPON RESOURCES, MOST IMPORTANTLY READERS, CARTRIDGES, CLINICAL SAMPLES, ET CETERA." AT THIS POINT IN TIME, AUGUST 21ST, HAD ANY ASSAYS BEEN VALIDATED FOR USE ON THE 3.0 OR THE 3.5 IN THE CLIA LAB?
SUREKHA GANGAKHEDKAR: I DON'T THINK SO.
MR. LEACH: IN THE NEXT PARAGRAPH YOU WROTE, QUOTE, "THE 'ASSAY OWNERS' WILL BE RESPONSIBLE FOR CLINICAL SOURCING AND ORDERING." WHAT WERE YOU GETTING AT WITH ASSAY OWNERS?
SUREKHA GANGAKHEDKAR: SO BECAUSE WE HAD LIKE A LARGE LIST OF ASSAYS, SO EACH ASSAYS HAD A PROJECT OWNER ESSENTIALLY WHO WOULD BE RESPONSIBLE FOR MAKING SURE THAT THE VALIDATION PLANNING AND ALL OF THE REQUIRED REAGENTS AND MATERIALS ARE READY AND AVAILABLE FOR THE TESTS.
MR. LEACH: AT THIS POINT IN TIME, AUGUST 21ST, 2013, WITH YOU WRITING THE WHOLE ELISA GROUP, ARE YOU CONFIDENT THAT YOU WERE BACK FROM VACATION AT THIS POINT?
MR. LEACH: AND WHEN YOU CAME BACK FROM VACATION, DID YOU HAVE MEETINGS OR CONVERSATIONS WITH MS. HOLMES ABOUT THERANOS'S READINESS TO GO LIVE ON THE 3.0 AND 3.5?
SUREKHA GANGAKHEDKAR: SO THERE WOULD BE LIKE SEVERAL MEETINGS IN A WEEK, AND WE HAD DISCUSSED THE ISSUES WITH THE 3.0'S, AND THAT IS WHERE THE NEED TO UPGRADE TO 3.5 HAD BEEN BROUGHT UP, AND THAT IS WHERE THEY WERE LOOKING TO, LIKE, PROVIDE ADDITIONAL DEVICES, THE 3.5'S THAT HAD NOT BEEN UPGRADED ENOUGH SO THEY WOULDN'T RUN INTO ANY PROBLEMS.
MR. LEACH: AND DID YOU ALSO HAVE DISCUSSIONS WITH MS. HOLMES ABOUT SOME OF THE RELIABILITY ISSUES AROUND THE 3.0?
SUREKHA GANGAKHEDKAR: SO AT THAT POINT I HAD ASKED -- BECAUSE SHARADA WAS IN THE CONVERSATIONS WHEN I WAS ON VACATION PLANNING FOR THE LDT LAUNCH, AND SO I HAD ASKED SHARADA IF MS. HOLMES AND DANIEL YOUNG WERE AWARE OF ALL OF THE PROBLEMS WITH THE 3.0'S, AND THEY STILL WANTED TO GO AHEAD WITH THIS LAUNCH. SO AT THAT TIME I HAD ASKED SHARADA SIVARAMAN TO RESEND AN EMAIL LISTING SOME OF THE FAILURES THAT WE HAD SEEN IN THE PAST AND LOOKING AT LIKE SOME OF THE RESULTS THAT WERE COMING IN FROM THE 3.5'S, IT SEEMED LIKE SIMILAR ERRORS WITH THE SYSTEMS AND HIGH CV'S WERE STILL OCCURRING.
MR. LEACH: LET ME HAVE YOU LOOK AT EXHIBIT 5106 WHICH I MOVE INTO EVIDENCE.
JUDGE DAVILA: IT'S RECEIVED AND ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5106 WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: SO THIS APPEARS TO BE AN EMAIL FROM MS. SIVARAMAN ON AUGUST 23RD, 2013, TO MS. HOLMES, DANIEL YOUNG, AND A COPY TO YOURSELF. DO YOU SEE THAT?
MR. LEACH: AND DO YOU SEE THE SUBJECT LINE 3.0 CARTRIDGE FAILURE REPORT FOR ACE-011?
MR. LEACH: OKAY. IS THIS THE EMAIL THAT YOU WERE REFERRING TO THAT YOU WANTED MS. SIVARAMAN TO CIRCULATE TO MS. HOLMES?
MR. LEACH: AND WHY WERE YOU -- WHY DID YOU WANT THIS TO BE SENT TO MS. HOLMES?
SUREKHA GANGAKHEDKAR: JUST SO THAT I THINK SHE IS AWARE AGAIN THAT WE HAVE HAD ISSUES WITH THE 3.0 DEVICES FOR SEVERAL YEARS AND LOOKING AT SOME OF THE DATA THAT WAS BEING GENERATED IN AUGUST OF 2013 FOR THE 3.5'S, WE ARE LOOKING -- WE ARE SEEING LIKE SIMILAR PROBLEMS, SO TO MAKE HER AWARE THAT WE ARE NOT YET OUT OF THOSE ISSUES AND THOSE ARE CONTINUING TO OCCUR.
MR. LEACH: LET ME PLEASE DRAW YOUR ATTENTION TO WHAT WE HAVE MARKED AS EXHIBIT 3958. I BELIEVE THERE'S A STIPULATION FOR 3958. I MOVE IT INTO EVIDENCE.
JUDGE DAVILA: WITHOUT OBJECTION, IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3958 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: AND IF WE CAN PLEASE HIGHLIGHT ON THE TOP PORTION OF THE FIRST EMAIL ESSENTIALLY. THANK YOU, MS. HOLLIMAN.
MR. LEACH: THE SUBJECT OF THIS EMAIL, MS. GANGAKHEDKAR IS MISSING DATA FROM 3.5 RUNS. WHAT WERE YOU GETTING AT THERE?
SUREKHA GANGAKHEDKAR: SO LOOKING AT THE EMAIL CHAIN, ESSENTIALLY GOING ON BETWEEN I THINK THE ASSAY DEVELOPER, WHO WAS RESPONSIBLE FOR THE RUNS, AND INDIVIDUALS FROM THE SOFTWARE TEAM, WE COULD NOT RETRIEVE THE DATA FOR THE RUNS THAT HAD COMPLETED. SO THAT IS WHY IT'S -- THE SUBJECT IS TITLED THAT THE DATA IS MISSING FROM THE SERVER FOR THE RUNS THAT HAD BEEN CONDUCTED.
MR. LEACH: WHY WAS THAT AN ISSUE, IF IT WAS AN ISSUE?
SUREKHA GANGAKHEDKAR: WELL, IF YOU COULDN'T SEE THE DATA, WE WOULDN'T KNOW HOW THE TEST WAS COMPLETED, WHETHER WE HAD A SUCCESSFUL RUN OR NOT.
MR. LEACH: OKAY. AND DO YOU SEE MS. HOLMES'S NAME IN THE TO LINE?
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION TO EXHIBIT 972, AND IF I COULD HAVE YOU PLEASE LOOK AT PAGE 4 OF EXHIBIT 972.
MR. LEACH: ARE YOU FAMILIAR WITH THIS DOCUMENT?
MR. LEACH: AND DO YOU SEE YOUR NAME AT THE TOP ABOVE THE BOLD LINE?
MR. LEACH: OKAY. AND IS THIS A TRUE AND CORRECT COPY OF AN EMAIL, OR THE FIRST PAGE OF AN EMAIL FROM DANIEL YOUNG TO YOU AND MS. HOLMES?
MR. LEACH: AND IS THIS A DOCUMENT THAT YOU PRINTED OUT AT SOME POINT IN TIME?
MR. LEACH: YOUR HONOR, THE GOVERNMENT MOVES FOR THE ADMISSION OF PAGE 4 OF EXHIBIT 972.
JUDGE DAVILA: JUST PAGE 4?
MR. LEACH: JUST PAGE 4 FOR NOW, YOUR HONOR.
JUDGE DAVILA: THANK YOU. PAGE 4 OF EXHIBIT 972 IS ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 972, PAGE 4 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: THANK YOU, MS. HOLLIMAN. IF WE CAN ZOOM IN ON THE FIRST TWO EMAILS FROM THE TOP.
MR. LEACH: MS. GANGAKHEDKAR, DO YOU SEE THE EMAIL AT THE BOTTOM AT 1:39 P.M. IS THIS ANOTHER COPY OF THE EMAIL WE WERE JUST LOOKING AT IN THE PRIOR EXHIBIT?
SUREKHA GANGAKHEDKAR: YES, IT IS.
MR. LEACH: AND IS THE TOP PORTION A FURTHER EMAIL IN THE THREAD FROM DANIEL YOUNG?
MR. LEACH: AND HE WROTE, "I RECOMMEND REPEATING THE FAILED RUNS. WE WILL NOTE IN THE STUDY REPORT THAT X NUMBER OF FAILED RUNS (DUE TO THE WRONG CARTRIDGES BEING USED) WERE RERUN." DO YOU SEE THAT LANGUAGE?
MR. LEACH: AND DO YOU -- WAS IT YOUR UNDERSTANDING THAT THE WRONG CARTRIDGES HAD BEEN USED FOR THIS TEST FOR THE 3.5?
SUREKHA GANGAKHEDKAR: NO, THE WRONG CARTRIDGES WERE NOT USED.
MR. LEACH: AND WERE YOU FRUSTRATED THAT DR. YOUNG WAS ATTRIBUTING THIS TO USE OF THE WRONG CARTRIDGES?
MR. LEACH: AND WHY WAS THAT?
SUREKHA GANGAKHEDKAR: BECAUSE IT WAS MISREPRESENTING THE TRUTH.
MR. LEACH: YOUR NAME IS UP IN THE TOP LEFT CORNER OF THIS DOCUMENT. DO YOU KNOW WHY THAT IS?
SUREKHA GANGAKHEDKAR: YES, BECAUSE I TOOK THAT PRINTOUT.
MR. LEACH: WHEN DID YOU TAKE THAT PRINTOUT?
SUREKHA GANGAKHEDKAR: I THINK ABOUT THE TIME THAT I RESIGNED.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION, PLEASE, TO AN EMAIL FROM THE NEXT DAY, EXHIBIT 3959. I UNDERSTAND THAT THE PARTIES STIPULATE TO THE ADMISSION OF 3959, AND ON THAT BASIS WE WOULD OFFER IT INTO EVIDENCE.
JUDGE DAVILA: ALL RIGHT. THANK YOU. IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3959 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE CAN ZOOM IN ON THE -- WONDERFUL.
MR. LEACH: MS. GANGAKHEDKAR, I DRAW YOUR ATTENTION TO THE EMAIL ON THE BOTTOM FROM ELIZABETH HOLMES ON SATURDAY, AUGUST 31ST. IT SAYS, "LET ME KNOW TOTAL NUMBER OF IMMUNOCHEMISTRY MICRO-SAMPLE ASSAYS THAT HAVE COMPLETED VALIDATION AS OF TOMORROW (ADVIA AND THERANOS PLATFORMS)." WHAT DID YOU UNDERSTAND THAT TO MEAN?
SUREKHA GANGAKHEDKAR: SO MS. HOLMES WANTED AN UPDATE OF HOW MANY ASSAYS HAD COMPLETED THE VALIDATION.
MR. LEACH: AND DID THAT APPLY TO ASSAYS THAT WERE BEING VALI -- WELL, WHAT DID THERANOS PLATFORMS MEAN IN YOUR MIND?
SUREKHA GANGAKHEDKAR: SO IT'S THE EDISON 3.0'S AND 3.5'S.
MR. LEACH: AND THE ADVIA IS -- IS THAT A REFERENCE TO THE MODIFIED SIEMENS MACHINES?
MR. LEACH: AND YOU WROTE BACK, "11 ASSAYS ON THE ADVIA HAVE COMPLETED PRECISION." DOES THAT MEAN THEY'RE DONE?
SUREKHA GANGAKHEDKAR: NO. THAT'S JUST ONE -- THERE ARE SEVERAL TESTS FOR A VALIDATION. I'M UPDATING THAT THUS FAR THEY HAVE COMPLETED ONE PARTICULAR KIND OF TESTING CALLED PRECISION TESTING.
MR. LEACH: AND THEN FURTHER ON IT READS, "FOR THE THERANOS SYSTEM WE PLAN TO COMPLETE THE EXPERIMENTS FOR PSA THIS WEEKEND. DETAILS FOR PSA ARE ATTACHED." IS THAT AN ACCURATE SUMMARY OF WHERE YOU WERE ON AUGUST 31ST, 2013, IN TERMS OF VALIDATING ASSAYS FOR USE ON THE 3.0 AND THE 3.5 IN CLIA?
SUREKHA GANGAKHEDKAR: THAT WAS THE PLAN.
MR. LEACH: OKAY. THAT WAS THE PLAN?
MR. LEACH: AND SO AT THIS POINT HAD YOU VALIDATED ANY?
MR. LEACH: NEXT I'D LIKE TO DRAW YOUR ATTENTION TO EXHIBIT 3964. DO YOU HAVE THAT IN FRONT OF YOU?
MR. LEACH: AND DO YOU SEE YOUR NAME AT THE TOP?
MR. LEACH: AND IS THIS AN EMAIL TO THE ELISA GROUP WITH THE EMAIL ADDRESS FOR ELISA LIKE WE SAW PREVIOUSLY?
MR. LEACH: AND ARE YOU FORWARDING INFORMATION FROM SUNNY BALWANI ABOUT SHIFTS IN SCHEDULES AND UPGRADED DEVICES?
MR. LEACH: DID YOU SEND THIS IN THE ORDINARY COURSE OF THERANOS'S BUSINESS?
MR. LEACH: OKAY. AND DID YOU PREPARE IT AT OR FROM INFORMATION KNOWN BY YOU AT THE TIME?
MR. LEACH: AND WAS IT THE REGULAR -- YOUR REGULAR PRACTICE TO UPDATE MEMBERS OF YOUR GROUP USING THE ELISA LIST OR ADDRESS?
MR. LEACH: YOUR HONOR, I OFFER EXHIBIT 3964 INTO EVIDENCE.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IS THERE THE ENTIRETY OF THIS EXHIBIT, THERE ARE TWO PAGES OR 4, 5 --
MR. LEACH: YES. THERE ARE SIX PAGES. THE LAST THREE ARE DATA. ONE IS A COMMUNICATION FROM MICHAEL CRAIG, A RESPONSE BY SUNNY BALWANI, AND THEN MS. GANGAKHEDKAR GIVING DIRECTION TO HER TEAM.
JUDGE DAVILA: AND YOU'RE ASKING THAT THE ENTIRETY OF THIS BE ADMITTED?
MR. LEACH: YES.
JUDGE DAVILA: ALL RIGHT. THE OBJECTION IS OVERRULED. THIS WILL BE ADMITTED. THANK YOU. SIX PAGES. IT CAN BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3964 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: THANK YOU, YOUR HONOR. MS. HOLLIMAN, I'D LIKE TO START ON PAGE 2. IF WE CAN MIGHT THE FIRST HALF OF THE DOCUMENTED UNTIL THE DATA TABLE. THAT'S FINE. THANK YOU, MS. HOLLIMAN.
MR. LEACH: THIS APPEARS TO BE AN EMAIL FROM MICHAEL CRAIG ON MONDAY, SEPTEMBER SECOND, 2013. WHO IS MICHAEL CRAIG?
SUREKHA GANGAKHEDKAR: I BELIEVE HE WAS A MEMBER OF THE SOFTWARE DEVELOPMENT TEAM.
MR. LEACH: AND HE'S WRITING WITH THE SUBJECT UPGRADED DEVICES, "I WAS ABLE TO MANUALLY UPGRADE THE FOLLOWING DEVICES WITH THE LATEST VERSION OF THE NORMANDY SHELL. THEY NOW HAVE VISUAL TEMPT INDICATORS IN THE MENU BAR: 3 POSITIONS," AND IT CONTINUES. DO YOU HAVE A SENSE OF WHAT HE WAS GETTING AT THERE, MS. GANGAKHEDKAR?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT ALL OF THE DETAILS AT THIS POINT.
MR. LEACH: OKAY. DOES THIS RELATE IN SOME WAY TO THE INTERFACE OF THE DEVICES?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. LEACH: OKAY. LET'S LOOK AT PAGE 1. AND I DRAW YOUR ATTENTION TO THE EMAIL AT THE BOTTOM OF THE PAGE FROM MR. BALWANI. MS. GANGAKHEDKAR, DO YOU SEE SUNNY BALWANI'S NAME IN THE FROM LINE ON THE DOCUMENT?
MR. LEACH: AND DO YOU SEE MS. HOLMES'S NAME IN THE CC LINE?
MR. LEACH: AND IS IT COMING UP ON YOUR SCREEN? DO YOU HAVE THE DOCUMENT ON YOUR SCREEN?
SUREKHA GANGAKHEDKAR: I DON'T HAVE IT ON THE SCREEN. I HAVE IT -- I'M LOOKING AT THE BINDER.
MR. LEACH: THERE WE GO.
SUREKHA GANGAKHEDKAR: THERE IT IS.
MR. LEACH: MR. BALWANI IS WRITING, "PLEASE NOTE THAT THE SOFTWARE TEAM WAS HERE AT 3:07 A.M. -- AND IS ALREADY HERE NOW AT 10:00
SUREKHA GANGAKHEDKAR: M. -- WORKING ON THIS AND OTHER MATTERS AND WILL CONTINUE TO DO SO FOR AS LONG AS IT TAKES. THE EDISON DEVICES IN THE EVENING WERE ALL SITTING IDLE AND I ALSO DIDN'T SEE ANYONE FROM CARTRIDGE MANUFACTURING IN THE EVENING." FURTHER ON IT SAYS, "PLEASE ASK THE ELISA TEAM TO ORGANIZE, PLAN AND PUT IN THE HOURS THIS MONTH TO BRING UP ALL ASSAYS AND WORK AROUND ANY CHALLENGES THAT COME OUR WAY." DO YOU SEE THAT LANGUAGE? A. YES.
MR. LEACH: AND DID YOU AGREE WITH WHAT MR. BALWANI WAS SAYING HERE?
MR. LEACH: WHY NOT?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE I KNEW THAT THE ELISA TEAM WAS REALLY WORKING HARD WITH NOT JUST, NOT JUST FOR THIS PROJECT BUT EVEN IN THE PAST AND JUST BECAUSE THE DEVICES SEEMED IDLE AT THAT POINT DID NOT REFLECT THAT THE TEAM WAS NOT WORKING HARD AS THEY WERE DIRECTED TO DO.
MR. LEACH: IS THIS AN EXAMPLE OF THE TYPE OF PRESSURE THAT YOU WERE UNDER?
MR. LEACH: OKAY. WAS THIS A MATTER OF FRUSTRATION TO YOU?
SUREKHA GANGAKHEDKAR: IT WAS.
MR. LEACH: WAS IT A MATTER OF FRUSTRATION TO YOUR TEAM?
MR. LEACH: WERE YOU CONVINCED THEY WERE DOING EVERYTHING POSSIBLE TO VALIDATE THESE ASSAYS APPROPRIATELY AS QUICKLY AS POSSIBLE?
MR. LEACH: AND WERE YOU CONVINCED THAT IT JUST WASN'T GETTING THERE?
SUREKHA GANGAKHEDKAR: IT -- YES, IT WASN'T GETTING THERE JUST BECAUSE IT, IT WAS A HUGE ENDEAVOR AND IT COULD NOT -- THE WORK THAT WE WERE DOING COULD NOT BE COMPARED DIRECTLY TO WHAT THE SOFTWARE TEAM WAS DOING.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO EXHIBIT 3968. ARE YOU FAMILIAR WITH THIS DOCUMENT?
MR. LEACH: IS THIS AN EMAIL FROM YOU TO FOLKS RESPONSIBLE FOR MANUFACTURING THE EDISON DEVICES?
MR. LEACH: AND DID YOU SEND THIS IN THE ORDINARY COURSE OF BUSINESS?
MR. LEACH: IS THIS EMAIL MADE AT OR NEAR THE TIME OF THE EVENTS IN QUESTION?
MR. LEACH: WAS THIS KEPT IN THE ORDINARY COURSE OF BUSINESS?
MR. LEACH: AND DID YOU FEEL LIKE YOU WERE UNDER A BUSINESS DUTY TO SPEAK TRUTHFULLY HERE IN REQUESTING INFORMATION OF THE EDISON GROUP?
MR. LEACH: YOUR HONOR, THE GOVERNMENT MOVES FOR THE ADMISSION OF EXHIBIT 3968?
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3968 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: IF WE CAN ZOOM IN ON THE SUBJECT LINE AND THE REST OF THE EMAIL DOWN TO LINE 15. THERE WE GO.
MR. LEACH: THE SUBJECT OF THIS IS EDISON 3.0'S. DO YOU SEE THAT MS. GANGAKHEDKAR?
MR. LEACH: AND YOU WRITE, "HERE IS THE LITIGATION: THESE HAVE ERROR OR FAILURE NOTES ON THEM." AND THERE'S A LIST OF 15 DIFFERENT NUMBERS. WHAT WERE YOU CONVEYING HERE?
SUREKHA GANGAKHEDKAR: SO THIS IS -- ESSENTIALLY THESE ARE LIKE THE I.D.'S FOR THE EDISONS IN THE DEVELOPMENT LAB, AND WE ARE PROVIDING THOSE TO THE OTHER RECIPIENTS IN THE EMAIL BECAUSE THEY WANTED TO KNOW WHICH EDISON 3.0'S THEY COULD UPGRADE TO 3.5'S.
MR. LEACH: OKAY. AND AT THIS POINT AT LEAST 15 OF THEM ARE HAVING ERROR OR FAILURE NOTES?
MR. LEACH: AND WAS THAT A MATTER OF FRUSTRATION TO YOU?
MR. LEACH: AND HOW SO?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE THAT MEANS THAT WE COULDN'T USE THOSE READERS REGULARLY FOR OUR WORK AND THEY WERE UNRELIABLE.
MR. LEACH: LET ME NEXT DRAW YOUR ATTENTION TO EXHIBIT 1109, WHICH I BELIEVE THE PARTIES STIPULATE TO THE ADMISSION OF EXHIBIT 1109 AND I WOULD OFFER IT.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1109 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: LET'S PLEASE LOOK AT PAGE 6 OF 1109. IF WE CAN ZOOM IN ON THE SUBSTANCE. IF THERE'S ANY WAY WE CAN GET THE DATE, TOO, MS. HOLLIMAN. THANK YOU. WONDERFUL.
MR. LEACH: DO YOU RECOGNIZE THIS, MS. GANGAKHEDKAR?
MR. LEACH: AND WHAT IS THIS?
SUREKHA GANGAKHEDKAR: THIS IS MY RESIGNATION LETTER.
MR. LEACH: OKAY. DID YOU HAND THIS TO MS. HOLMES?
MR. LEACH: AND DID YOU RESIGN ON OR ABOUT SEPTEMBER 5TH, 2013?
MR. LEACH: AND WHY DID YOU RESIGN?
SUREKHA GANGAKHEDKAR: BECAUSE I WAS VERY STRESSED AND UNHAPPY AND CONCERNED WITH THE WAY THE LAUNCH PLANS OR THE LAUNCH WAS GOING. I WAS NOT COMFORTABLE WITH THE PLANS THAT THEY HAD IN PLACE SO I MADE A DECISION TO RESIGN AND NOT CONTINUE WORKING THERE.
MR. LEACH: OKAY. DID YOU SPEAK TO MS. HOLMES ABOUT YOUR RESIGNATION?
MR. LEACH: WHERE DID YOU SPEAK WITH HER?
SUREKHA GANGAKHEDKAR: IN HER OFFICE.
MR. LEACH: HOW LONG DID YOUR MEETING LAST?
SUREKHA GANGAKHEDKAR: I HAD I THINK SEVERAL MEETINGS THROUGHOUT -- I MEAN, THAT MORNING WITH HER. SO EACH MEETING HAD LASTED SEVERAL MINUTES.
MR. LEACH: WAS ANYONE ELSE THERE WHILE YOU WERE MEETING WITH HER?
MR. LEACH: AND IN ONE OF THOSE MEETINGS DID YOU HAND HER YOUR RESIGNATION LETTER?
MR. LEACH: AND DID YOU SPEAK WITH HER ABOUT SOME OF THE ISSUES THAT PROMPTED YOUR RESIGNATION?
SUREKHA GANGAKHEDKAR: I DID.
MR. LEACH: TAKE A MOMENT AND DESCRIBE FOR US AS BEST YOU CAN THE SUBSTANCE OF WHAT WAS SAID.
SUREKHA GANGAKHEDKAR: YES. SO I DID RAISE THE CONCERNS OF HOW SHE PLANS TO LAUNCH WITH THE EDISON 3.0'S GIVEN THAT WE HAVE SEEN IN THE LAST FEW DAYS THAT THEY CONTINUE TO HAVE ISSUES. AND AT THAT TIME SHE MENTIONED SOMETHING ALONG THE LINES THAT WHEN SHE HAS A PROMISE TO DELIVER TO THE CUSTOMER, SHE DOESN'T HAVE MUCH OF A CHOICE BUT TO GO AHEAD WITH THE LAUNCH.
MR. LEACH: MS. HOLMES SAID SHE DIDN'T HAVE MUCH OF A CHOICE?
SUREKHA GANGAKHEDKAR: YEAH.
MR. LEACH: DID YOU RAISE WITH HER RELIABILITY ISSUES WITH THE 3.5?
SUREKHA GANGAKHEDKAR: SO SINCE SHE WAS ON THE EMAILS THE LAST WEEK ABOUT WE ARE CONTINUING TO SEE THE PROBLEMS WITH THE 3.5'S, I BELIEVE SHE WAS FULLY AWARE THAT THE 3.5'S WERE NOT ANY MARKED IMPROVEMENT COMPARED TO THE 3.0'S.
MR. LEACH: AND DID YOU DISCUSS WITH HER ANY ISSUES RELATING TO THE NANOTAINERS?
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. LEACH: AND WHAT WAS SAID?
SUREKHA GANGAKHEDKAR: SO I ALSO EXPRESSED CONCERNS OF HOW SHE PLANS TO LAUNCH USING THE NANOTAINERS FOR BLOOD COLLECTION GIVEN THAT PRETTY MUCH EACH DAY WE WOULD BE TESTING THOSE AND WE WOULD CONTINUE TO SEE SIMILAR FAILURES. SO THAT IS WHEN SHE MENTIONED THAT SHE PLANS TO LAUNCH WITH DRAWING TWO TUBES OF VENOUS BLOOD INSTEAD OF THE NANOTAINERS.
MR. LEACH: WAS THAT EXPLANATION SATISFACTORY TO YOU?
MR. LEACH: WHY NOT?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE I BELIEVED THAT THE LAUNCH WAS BASED ON USING THE NANOTAINERS INSTEAD OF USING SAMPLES DRAWN BY VENOUS BLOOD.
MR. LEACH: DID YOU FEEL IT WAS MISLEADING TO DRAW FROM VENOUS BLOOD?
JUDGE DAVILA: AS TO THE FORM OF THE QUESTION. YOU CAN REASK THE QUESTION. I SUSTAINED THE QUESTION. THAT ANSWER IS STRICKEN, LADIES AND GENTLEMEN. YOU CAN REASK A QUESTION.
BY MR. LEACH:
MR. LEACH: WHY WAS IT, MS. GANGAKHEDKAR, YOU WERE NOT SATISFIED WITH THE EXPLANATION? WHAT WAS IT ABOUT THE FACT THAT THERANOS PLANNED TO DRAW FROM A VEIN THAT WAS NOT SATISFACTORY TO YOU?
SUREKHA GANGAKHEDKAR: WELL, BECAUSE I UNDERSTOOD FOR THE LAUNCH THAT THE -- SOME OF THE LAUNCH DETAILS INCLUDED THE USE OF NANOTAINERS TO TEST FOR SAMPLES -- I'M SORRY. THE USER BLOOD DRAWN OR COLLECTED IN NANOTAINERS TO BE TESTED ON THE THERANOS SYSTEM.
MR. LEACH: AND WHAT IS IT ABOUT THAT BEING THE PLAN THAT MADE YOU NOT SATISFIED?
SUREKHA GANGAKHEDKAR: WELL, THE USE OF VENOUS DRAW WAS NOT, THAT INFORMATION WAS NOT RELEASED TO EVERYONE. I DON'T THINK -- I WAS NOT AWARE THAT THE LAUNCH WOULD ACTUALLY USE VENOUS DRAW. I WAS UNDER THE IMPRESSION THAT WE WERE USING NANOTAINERS.
MR. LEACH: AND HOW DID YOU FEEL ABOUT THAT?
JUDGE DAVILA: OVERRULED. YOU CAN ANSWER THE QUESTION.
SUREKHA GANGAKHEDKAR: SO I DIDN'T FEEL -- I FELT THAT IT WAS NOT THE RIGHT THING TO DO.
BY MR. LEACH:
MR. LEACH: AT THIS POINT IN 2013, HOW LONG HAD YOU BEEN WORKING AT THERANOS?
SUREKHA GANGAKHEDKAR: EIGHT YEARS.
MR. LEACH: AND COULD WE HAVE THE RESIGNATION LETTER BACK UP, PLEASE. AND YOU WROTE IN YOUR LETTER, "I'VE MADE THE DIFFICULT DECISION OF RESIGNING FROM MY POSITION AT THERANOS." WHY WAS THIS A DIFFICULT DECISION FOR YOU?
SUREKHA GANGAKHEDKAR: IT WAS DIFFICULT BECAUSE THE LAST EIGHT YEARS OF WORKING AT THERANOS IT REALLY FELT THAT IF I'M GOING TO MAKE A DIFFERENCE IN DEVELOPING A NEW PRODUCT, AND EACH TIME THE COMPANY CHANGED DIRECTION TO LIKE A VERSION OF A NEW SYSTEM I WAS STILL MOTIVATED, AND IT PUSHED US TO DO THE BEST THAT WE COULD DOING WHAT WAS BEST FOR THE ASSAY DEVELOPMENT AND IN THE PRODUCT. SO COMING AND HEARING IN THE LAST FEW YEARS THAT THERE WERE -- OF COURSE COMMUNICATING THAT THERE WERE ISSUES WITH THE EDISON SYSTEMS, AND AFTER HAVING HEARD THAT THE EDISON 3.0'S WILL ONLY BE USED FOR A SHORT TIME UNTIL WE HAVE A NEW IMPROVED SYSTEM THAT WOULD RUN INTO ALL OF THE ISSUES THAT WE HAD BEFORE, IT SEEMS LIKE A HUGE LETDOWN FROM ALL, FROM ALL OF THE HARD WORK THAT WAS CONDUCTED. IT FELT THAT ALL OF -- LIKE MY EFFORTS AND THE EFFORTS OF MY TEAM MEMBERS ARE GOING TO WASTE BECAUSE WE ARE NOW LAUNCHING NO MATTER WHAT WITH 3.0'S. SO ALL IN ALL IT WAS A DIFFICULT SITUATION.
MR. LEACH: DID ANY MEMBERS OF YOUR STAFF RESIGN TO YOU THAT SAME DAY?
MR. LEACH: WHO WAS THAT?
SUREKHA GANGAKHEDKAR: TINA NOYES.
MR. LEACH: AND DID YOU IN ANY WAY COORDINATE WITH MS. NOYES OR WAS IT A FORTUITY THAT YOU TWO RESIGNED ON THE SAME DAY?
SUREKHA GANGAKHEDKAR: NO, THERE WAS NO COORDINATION. SO ON THE DAY I SUBMITTED MY RESIGNATION TO MS. HOLMES AND I WENT BACK TO MY DESK, AND THAT IS WHEN TINA NOYES APPROACHED ME AND SAID SHE WANTED TO SPEAK TO ME AND PRIVATELY, AND SO IN THE CONFERENCE ROOM SHE SUBMITTED HER RESIGNATION TO ME. THAT IS WHEN I INFORMED HER THAT, YES, I ALSO HAVE RESIGNED. SO WE HADN'T SPOKEN ABOUT OUR PLANS BEFORE.
MR. LEACH: IT'S NOT HEARSAY. IT'S A VERBAL ACT.
JUDGE DAVILA: I WAS THINKING ABOUT THE ENTIRETY OF THE STATEMENT TO COME IN. I'LL ALLOW IT TO COME IN. THE OBJECTION IS OVERRULED.
BY MR. LEACH:
MR. LEACH: AFTER RESIGNING TO MS. HOLMES ON OR ABOUT SEPTEMBER 5TH, DID YOU PRINT OUT ANY DOCUMENTS RELATING TO YOUR WORK AT THERANOS?
MR. LEACH: AND WHEN YOU PRINTED THEM OUT, WHERE DID YOU PUT THEM? WHAT DID YOU DO WITH IT?
SUREKHA GANGAKHEDKAR: SO I TOOK THEM HOME.
MR. LEACH: AT THE TIME THAT YOU TOOK THOSE HOME, HAD YOU SIGNED ANY FORM OF NONDISCLOSURE AGREEMENT WITH THERANOS?
MR. LEACH: IN PRINTING OUT THOSE DOCUMENTS AND TAKING THEM HOME WITH YOU, DID YOU HAVE CONCERNS IN LIGHT OF THE NONDISCLOSURE AGREEMENT THAT YOU SIGNED?
MR. LEACH: AND WHY?
SUREKHA GANGAKHEDKAR: BECAUSE THERANOS WAS, WAS PRETTY TOUGH ON THEIR NDA'S AS WELL AS THEIR PROPRIETARY INFORMATION.
MR. LEACH: AND NOTWITHSTANDING THE FACT THAT YOU HAD SIGNED AN NDA, WHY DID YOU PRINT OUT AND TAKE HOME DOCUMENTS FROM THERANOS?
JUDGE DAVILA: I'LL ALLOW HER TO TESTIFY SUBJECT TO A MOTION TO STRIKE. YOU CAN ANSWER THE QUESTION.
SUREKHA GANGAKHEDKAR: YEAH. SO THE REASON I TOOK THOSE PRINTOUTS IS BECAUSE I WAS WORRIED ABOUT THE LAUNCH. I WAS ACTUALLY SCARED THAT THINGS WOULD NOT GO WELL. AND I WAS ALSO WORRIED THAT I WOULD BE BLAMED, THAT MS. HOLMES WAS NOT AWARE OF WHAT WAS HAPPENING WITH THE 3.0'S. SO ESSENTIALLY I TOOK THOSE TO PROTECT MYSELF AND TO HAVE AS A RECORD IN THE EVENT ISSUES CAME UP IN THE FUTURE.
BY MR. LEACH:
MR. LEACH: WHY WERE YOU SCARED?
JUDGE DAVILA: SUSTAINED. THE PREVIOUS ANSWER WILL REMAIN. SUSTAIN THE OBJECTION.
MR. LEACH: THANK YOU, YOUR HONOR.
MR. LEACH: AND WE LOOKED EARLIER AT EXHIBIT 972, PAGE 4. IS THAT ONE OF THE DOCUMENTS THAT YOU PRINTED OUT AND TOOK WITH YOU?
MR. LEACH: MAY I HAVE A MOMENT, YOUR HONOR?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
BY MR. LEACH:
MR. LEACH: THANK YOU, MS. GANGAKHEDKAR. I HAVE NOTHING FURTHER.
JUDGE DAVILA: ANY CROSS-EXAMINATION?
JUDGE DAVILA: FOLKS, IF YOU WANT TO STAND AND STRETCH FOR A MOMENT, FEEL FREE. YOU, TOO, MS. GANGAKHEDKAR.
(STRETCHING.)
JUDGE DAVILA: MR. WADE?
CROSS-EXAMINATION BY MR. WADE:
MR. WADE: GOOD AFTERNOON, MS. GANGAKHEDKAR. MY NAME IS LANCE WADE, AND I REPRESENT MS. HOLMES, AND I HAVE A FEW QUESTIONS FOR YOU TODAY, TOO.
SUREKHA GANGAKHEDKAR: SURE.
MR. WADE: OKAY. I'D LIKE TO START JUST BY MAKING SURE THAT WE UNDERSTAND YOUR ROLE. YOU WORKED IN THE RESEARCH AND DEVELOPMENT DEPARTMENT; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: YES, CORRECT.
MR. WADE: AND SO YOUR -- A LOT OF YOUR WORK WAS TO BE IN ADVANCE OF MOVING THE ASSAYS OVER INTO THE CLIA LAB; IS THAT RIGHT?
MR. WADE: AND AT THE TIME -- I FORGOT I COULD TAKE THIS OFF. AT THE TIME THAT YOU -- IN THIS TIME IN SEPTEMBER OF 2013 THAT YOU'RE JUST TALKING ABOUT, NONE OF THE ASSAYS THAT WERE UNDER DISCUSSION HAD GONE INTO THE CLIA LAB; RIGHT?
MR. WADE: AND WE HAD SEEN SOME DOCUMENTS FROM MR. YOUNG WHERE HE HAD PROPOSED SOMETHING IN THE ORDER OF 62 SMALL SAMPLE ASSAYS THAT WERE TO GO ON TO THE EDISON; IS THAT RIGHT?
MR. WADE: AND THEN THERE WAS ANOTHER SET OF DOCUMENTS WHERE THAT NUMBER WAS WHITTLED DOWN TO MAYBE A DOZEN OR SOMETHING. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT.
MR. WADE: OKAY. BUT YOU RECALL THAT IT WAS SUBSTANTIALLY -- THE LIST WAS NARROWED DOWN JUST IN THAT TIME PERIOD AFTER YOU WERE BACK FROM INDIA. DO YOU RECALL THAT?
SUREKHA GANGAKHEDKAR: SO -- CAN YOU PLEASE REPEAT THE QUESTION AND --
MR. WADE: SURE. THE BEGINNING UNIVERSE OF ASSAYS THAT YOU'RE FOCUSSED ON WITH THE EDISON WAS 62 IN THE PLAN THAT DR. YOUNG LAID OUT. DO YOU RECALL THAT?
MR. WADE: OKAY. AND THEN IN THE PERIOD -- THERE WAS A -- THAT WAS RIGHT AFTER YOU CAME BACK FROM INDIA; ISN'T THAT RIGHT?
MR. WADE: AND IN THE PERIOD BETWEEN WHEN YOU CAME BACK FROM INDIA AND WHEN YOU RESIGNED, THERE WERE -- THEY NARROWED THAT LIST DOWN. THEY DECIDED THEY WEREN'T GOING TO GO FORWARD WITH 62; RIGHT?
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT ALL OF THOSE DETAILS.
MR. WADE: YOU DON'T. OKAY. WELL, WE'LL GO THROUGH SOME DOCUMENTS TODAY AND MAYBE ON TUESDAY, OKAY?
SUREKHA GANGAKHEDKAR: OKAY.
MR. WADE: THE VALIDATION PROCESS, THE CLIA VALIDATION PROCESS WHERE, WHERE AN ASSAY IS CERTIFIED BEFORE IT GOES INTO THE LAB, WHO WAS RESPONSIBLE FOR THE CLIA VALIDATION?
SUREKHA GANGAKHEDKAR: I THINK IT WOULD BE THE CLIA LAB DIRECTOR.
SUREKHA GANGAKHEDKAR: DR. ADAM ROSENDORFF.
SUREKHA GANGAKHEDKAR: SO HE -- I THINK HE HAD AN OVERVIEW OF THE PLAN, BUT WHAT EXACTLY DO YOU MEAN WITH YOUR QUESTION? CAN YOU ELABORATE?
MR. WADE: I'M SORRY TO INTERRUPT YOU. DID YOU WORK WITH HIM ON ANY OF THE CLIA VALIDATION REPORTS?
SUREKHA GANGAKHEDKAR: I DON'T KNOW.
MR. WADE: OKAY. THERE WERE A LOT OF DOCUMENTS THAT THE GOVERNMENT WENT THROUGH WITH YOU WITH RESPECT TO VARIOUS ISSUES THAT WERE COMING UP ON DIFFERENT DEVICES. DO YOU RECALL SOME OF THOSE DOCUMENTS THAT, THAT CAME UP TODAY?
MR. WADE: AND I JUST WANT TO MAKE SURE THAT EVERYONE IS CLEAR, ALL OF THAT WORK WAS DONE WITHIN RESEARCH AND DEVELOPMENT; RIGHT?
MR. WADE: TO TRY AND GET THE EQUIPMENTS AND THE ASSAYS AND EVERYTHING FUNCTIONING PROPERLY BEFORE THEY WERE USED ON PATIENTS; RIGHT?
MR. WADE: AND THERE WERE ABSOLUTELY NO PATIENT SAMPLES THAT WERE IMPLICATED BY ANY OF THOSE ISSUES THAT YOU TALKED ABOUT AT THE TIME OF THOSE DOCUMENTS; RIGHT?
SUREKHA GANGAKHEDKAR: I DON'T KNOW BECAUSE WE WERE STILL RUNNING THE TESTS TO PREPARE FOR THE VALIDATION.
SUREKHA GANGAKHEDKAR: I DON'T RECOLLECT THAT.
MR. WADE: OKAY. WELL, IS IT YOUR UNDERSTANDING THAT IN THE TIME THAT YOU WERE AT THERANOS, THAT THE 4 SERIES DEVICE THAT THE GOVERNMENT WAS ASKING YOU ABOUT, WAS THAT EVER USED IN THE CLIA LAB IN THE TIME THAT YOU WERE THERE?
SUREKHA GANGAKHEDKAR: I DON'T THINK SO.
MR. WADE: OKAY. AND I THINK WE'VE TALKED ABOUT THERE WERE SOME EFFORTS TO TRY TO GET SOME ASSAYS WORKING ON THE 3 SERIES DEVICES; RIGHT?
MR. WADE: AND AT THE TIME THAT YOU LEFT, NONE OF THEM HAD ACTUALLY BEEN VALIDATED TO GO INTO THE CLIA LAB; RIGHT?
SUREKHA GANGAKHEDKAR: AT THE TIME OF MY RESIGNATION, I WAS NOT AWARE OF ANY VALIDATION FOR THE 3.0'S HAD COMPLETED.
SUREKHA GANGAKHEDKAR: SO IS THIS WITH RELATION TO THE NANOTAINERS?
MR. WADE: NO. IT WAS IN CONNECTION -- YOU RECALL WITH THE VENOUS SAMPLES, TO DO THE LAUNCH, IF NECESSARY, SOME VENOUS SAMPLES WOULD BE USED. DO YOU RECALL THAT IN YOUR DISCUSSION WITH MS. HOLMES?
MR. WADE: AND THE THOUGHT WOULD BE IF THE TEST ON THE FINGERSTICK WEREN'T FUNCTIONING PROPERLY, YOU WOULD DO THEM ON A DIFFERENT METHOD; RIGHT?
SUREKHA GANGAKHEDKAR: I WAS NOT AWARE OF THAT BACKUP PLAN.
MR. WADE: OKAY. BUT YOU KNEW THAT THEY HAD OTHER COMMERCIAL DEVICES WITHIN THE LABORATORIES; RIGHT?
MR. WADE: NOW, THERE'S BEEN SOME DISCUSSION ABOUT THE NUMBER OF ASSAYS THAT WERE DEVELOPED WITHIN THE R&D GROUP THAT HAD COMPLETED -- WHERE YOU HAD COMPLETED YOUR WORK. DO YOU RECALL TALKING A LITTLE BIT ABOUT THAT?
SUREKHA GANGAKHEDKAR: SO IS THIS SPECIFICALLY RELATED TO THE RETAIL LAUNCH?
MR. WADE: NO. NO. MORE GENERALLY. LET'S STEP BACK A BIT HERE IF WE COULD, OKAY? AND YOU HAD WORKED, I BELIEVE YOU TESTIFIED, IN THE R&D DEPARTMENT, FOR MANY YEARS; RIGHT?
SUREKHA GANGAKHEDKAR: UH-HUH.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND THEN THERE CAME A TIME IN MAYBE 2009 OR 2010 WHERE THERE WERE SOME ADDITIONAL ASSAY TEAMS THAT WERE SET UP; RIGHT?
SUREKHA GANGAKHEDKAR: SO BASICALLY THEY HAD GENERAL CHEMISTRY, THEY HAD SOME MOLECULAR BIOLOGY ASSAYS, AS WELL AS THE CYTOMETRY ASSAYS.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: AND IN THAT PERIOD OF YEARS WHERE YOU WORKED THERE, YOU WERE TO DEVELOP A LOT OF IMMUNOASSAYS; RIGHT?
MR. WADE: AND DO YOU RECALL THE APPROXIMATE NUMBER OF IMMUNOASSAYS THAT YOU HAD COMPLETED WORK ON IN THE R&D LAB?
SUREKHA GANGAKHEDKAR: IT WOULD BE APPROXIMATELY A HUNDRED.
SUREKHA GANGAKHEDKAR: CORRECT.
MR. WADE: I'D LIKE TO ASK YOU A LITTLE BIT ABOUT THAT WORK WITH GLAXO SMITH KLINE. DO YOU RECALL THE QUESTIONS ABOUT THAT EARLIER?
SUREKHA GANGAKHEDKAR: SO THERE WERE A PANEL, LIKE A METABOLIC PANEL. SO THEY HAD ONE TARGET CALLED GLP-1, AND THEY HAD ANOTHER ONE CALLED C-PEPTIDE.
MR. WADE: AND BEFORE YOU, YOU HAVE BROUGHT THOSE ASSAYS OUT TO WORK WITH GSK, DID YOU DO THE WORK NECESSARY TO BE COMFORTABLE HOW THEY WERE GOING TO PERFORM?
SUREKHA GANGAKHEDKAR: I WOULD THINK SO.
MR. WADE: AND THE CARTRIDGES USED IN THAT STUDY, DO YOU RECALL HOW MANY ASSAYS THEY WOULD RUN? WOULD THEY RUN THE ASSAYS IN A SINGLE CARTRIDGE?
MR. WADE: AND I THINK THERE WAS A COMMUNICATION -- WHY DON'T WE BRING UP 112, WHICH I THINK IS IN EVIDENCE. AND IF WE CAN GO -- DO YOU RECALL THIS EMAIL?
MR. WADE: AND IF WE CAN GO -- ACTUALLY, BEFORE WE GO THERE, DR. RHODES, DO YOU RECALL THAT HE WAS THE LAB DIRECTOR FOR THE BIOMARKER LAB AT GSK?
SUREKHA GANGAKHEDKAR: IT IS.
MR. WADE: AND CAN WE GO TO THE ATTACHMENT, AND THE NEXT PAGE, PLEASE. IF WE CAN BLOW UP THE OVERALL CONCLUSIONS. I THINK WE DIDN'T FOCUS TOO MUCH ON THIS. THIS WAS A DOCUMENT THAT WAS PREPARED BY DR. RHODES; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: WELL, WHY DON'T WE LOOK BACK AT THE EMAIL JUST SO WE CAN SEE IF WE CAN REFRESH YOUR RECOLLECTION. DO YOU SEE DOWN BELOW DR. RHODES IS SENDING THIS AND COMMUNICATING IT TO THE COMPANY AT LEAST; RIGHT?
MR. WADE: AND NOW, HE HAS A TEAM OF PEOPLE AT GLAXO SMITH KLINE THAT HE SEEMS TO BE WORKING WITH ON THAT, SOME COMBINATION OF THEM ASSUMEDLY WROTE THIS DOCUMENT?
SUREKHA GANGAKHEDKAR: UH-HUH.
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. LET'S GO BACK TO THAT SECOND PAGE, AND LET'S LOOK AT THE OVERALL CONCLUSIONS. THIS SAYS THAT "THE THERANOS SYSTEM ELIMINATES THE NEED FOR A LAB AND PROVIDED QUALITY DATA." DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: YES, OF COURSE.
MR. WADE: AND YOU RECALL ACTUALLY AS A RESULT OF THIS WORK, THERE WAS A CELEBRATION AT THE COMPANY AFTERWARD; RIGHT?
SUREKHA GANGAKHEDKAR: YES, THERE WAS.
MR. WADE: AND LET'S LOOK AT THE SECOND BULLET POINT. OKAY. THIS SAYS, "THE METABOLIC BIOMARKER LAB," THAT MEANS THE METABOLIC BIOMARKER LAB AT GSK; IS THAT RIGHT?
MR. WADE: OKAY. AND THIS SAYS THEY HAVE A FAVORABLE IMPRESSION OF THE TECHNOLOGY AND SYSTEM AND RECOMMENDS THAT GSK CLINICAL GROUPS WORK WITH THERANOS TO IDENTIFY THE BEST USE OF THIS TECHNOLOGY. DO YOU SEE THAT?
MR. WADE: AND SO THEY WERE RECOMMENDING TO OTHER CLINICAL GROUPS WITHIN GLAXO SMITH KLINE THAT THEY SHOULD THINK ABOUT USING THERANOS AS A RESULT OF YOUR WORK; RIGHT?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: OKAY. ARE YOU AWARE THAT DR. RHODES ACTUALLY WROTE SEPARATELY TO MS. HOLMES TO PRAISE YOUR WORK?
MR. LEACH: OBJECTION. FOUNDATION.
JUDGE DAVILA: WOULD YOU LAY A FOUNDATION.
MR. WADE: I WAS JUST ASKING IF SHE'S AWARE. IF SHE'S NOT AWARE, I CAN LAY THE FOUNDATION. BUT I CAN DO IT IF YOUR HONOR WOULD PREFER.
JUDGE DAVILA: WELL, DID YOU UNDERSTAND HIS QUESTION?
JUDGE DAVILA: YOU CAN ANSWER.
SUREKHA GANGAKHEDKAR: I WAS NOT AWARE. I HADN'T SEEN THAT -- I DON'T THINK I HAD SEEN THAT EMAIL DIRECTLY.
BY MR. WADE:
MR. WADE: OKAY. LET ME SEE IF I CAN REFRESH YOUR RECOLLECTION. I THINK IF YOU LOOK IN YOUR BOOK AT 13764.
SUREKHA GANGAKHEDKAR: CAN YOU PLEASE REPEAT THAT NUMBER AGAIN, THE NUMBER FOR THE --
COURT CLERK: I THINK SHE ONLY HAS THE GOVERNMENT BINDER.
SUREKHA GANGAKHEDKAR: I DON'T THINK I HAVE THAT IN THIS BINDER.
MR. WADE: MY APOLOGIES. I FORGOT TO GIVE YOU OUR BINDER. ONE MOMENT, PLEASE. WE CAN JUST PUT IT ON THE SCREEN, YOUR HONOR. WE WON'T NEED TO --
JUDGE DAVILA: OKAY. IF WE CAN HAVE COUNSEL ADJUST THEIR MONITORS.
JUDGE DAVILA: PLEASE.
MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION THAT DR. RHODES HAD COMMUNICATED THAT YOU HAD DONE A GREAT JOB?
SUREKHA GANGAKHEDKAR: I THINK SO.
MR. WADE: AND DOES IT REFRESH YOUR RECOLLECTION THAT DR. RHODES THOUGHT THE INSTRUMENTS PERFORMED WELL?
MR. WADE: AND PART OF THE ISSUE WITH GLAXO SMITH KLINE WAS ALSO THAT THEY WERE LOOKING FOR AN ASSAY THAT WOULD RUN A LITTLE FASTER; RIGHT?
SUREKHA GANGAKHEDKAR: IT DID.
MR. WADE: IF WE CAN GO BACK TO THAT ATTACHMENT FOR JUST ONE SECOND. AGAIN, WE'RE AT 112, WHICH IS IN EVIDENCE. I APOLOGIZE. JUST SO THE RECORD IS CLEAR, I WOULD LIKE TO BRING YOU BACK TO EXHIBIT 112, WHICH IS THE DOCUMENT REALLY AT THE GLAXO SMITH KLINE THAT WE WERE TALKING ABOUT EARLIER.
SUREKHA GANGAKHEDKAR: UH-HUH.
MR. WADE: AND I'D LIKE TO DRAW YOUR ATTENTION TO THE FIRST PAGE OF THE ATTACHMENT AND THE TOP PARAGRAPH. I DON'T THINK YOU WERE ASKED ABOUT THIS PREVIOUSLY. DO YOU SEE THERE WHERE IT SAYS THAT THE TWO ASSAYS WERE COMPARED TO GOLD STANDARD ELISA'S. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: SO GSK WAS USING A SET OF ASSAYS IN THEIR LAB FOR THEIR STUDIES FOR THESE PARTICULAR TARGETS, AND THEY WERE CONSIDERED TO BE THE BEST ASSAY TO USE FOR THOSE PURPOSES.
SUREKHA GANGAKHEDKAR: IT DID.
MR. WADE: AND IF WE CAN GO BACK TO THE LAST PAGE ONE MORE TIME. DO YOU SEE -- FOCUS ON THE TOP. DO YOU SEE AT THE TOP THERE THAT IT SAYS THE DATA SHOWED GOOD CORRELATION. DO YOU SEE THAT?
SUREKHA GANGAKHEDKAR: UH-HUH.
SUREKHA GANGAKHEDKAR: YES, I DID.
MR. WADE: I DON'T HAVE ANY OTHER QUESTIONS ON THAT DOCUMENT. IF I CAN ASK YOU, I THINK THE DOCUMENT THAT YOU SENT TO MS. HOLMES THAT RELATED TO SOME WORK THAT WAS DONE FOR CELGENE; IS THAT RIGHT?
SUREKHA GANGAKHEDKAR: IT WAS.
JUDGE DAVILA: YOU KNOW, EXCUSE ME. BEFORE WE MOVE IN -- I DON'T WANT TO BREAK UP --
(LAUGHTER.)
JUDGE DAVILA: THIS TIME I WON'T LET YOU ASK A QUESTION. THE WEEKEND IS TOO LONG TO WAIT FOR THE ANSWER SO.
JUDGE DAVILA: LET'S DO THAT. I APPRECIATE THAT. WE'RE GOING TO RECESS FOR THE DAY AND THE WEEKEND AND WE'LL COME BACK ON TUESDAY NEXT AT 9:00 O'CLOCK, AND I HOPE WE CAN BEGIN -- LADIES AND GENTLEMEN, LET ME -- YES, SORRY. LET ME AGAIN REMIND YOU, LADIES AND GENTLEMEN, THAT AFTER YOU LEAVE TONIGHT, YOU'RE NOT TO CONDUCT ANY INDEPENDENT RESEARCH ABOUT THE CASE, THE MATTERS DEALING WITH THE CASE, OR ANY OF THE PARTIES INVOLVED WITH THE CASE, INCLUDING ANY LEGAL ISSUES INVOLVED IN THE CASE. YOU ALSO MUST NOT COMMUNICATE WITH ANYONE ABOUT THE CASE. AND YOU MUST IGNORE ANY INFORMATION THAT YOU MAY COME UPON WHILE BROWSING THE INTERNET OR ANY OF YOUR SOCIAL MEDIA. AND PLEASE DO NOT DISCUSS THE CASE WITH ANYONE UNTIL THE MATTER HAS BEEN DELIVERED TO YOU FOR YOUR DELIBERATIONS. THANK YOU FOR YOUR PATIENCE. IT'S IMPORTANT THAT I MAKE A RECORD OF THIS EACH TIME WE BREAK. AND YOU KNOW THE QUESTION I'M GOING TO ASK YOU WHEN WE SEE EACH OTHER ON TUESDAY, AND I'D LIKE A REPORT IF ANY OF THIS HAS OCCURRED TO YOU OVER THE WEEKEND, INADVERTENT OR NOT. HAVE A GOOD WEEKEND. BE SAFE. ENJOY THE WEEKEND. WE WILL SEE YOU TUESDAY NEXT, TUESDAY NEXT, AND I HOPE WE CAN START AT 9:00 O'CLOCK. THANK YOU. YOU CAN STAND DOWN, AND WE'LL SEE YOU TUESDAY AS WELL. THANK YOU.
(JURY OUT AT 1:59 P.M.)
JUDGE DAVILA: PLEASE, YOU CAN STAND DOWN. IS THAT A BINDER OF THE EXHIBITS?
SUREKHA GANGAKHEDKAR: NO. THIS BELONGS TO THE PROSECUTION.
JUDGE DAVILA: OH, YOU CAN LEAVE THAT. THANK YOU SO MUCH. PLEASE BE SEATED. THANK YOU. PLEASE BE SEATED. THANK YOU, LADIES AND GENTLEMEN. ALL RIGHT. THANK YOU. THE JURY AND ALTERNATES HAVE LEFT FOR THE WEEKEND AND MS. HOLMES AND COUNSEL ARE STILL PRESENT. ANYTHING BEFORE WE BREAK FOR THE WEEKEND, COUNSEL? I HEAR NO RESPONSE. THAT SUGGESTS YOU'RE COMPLETELY SATISFIED.
JUDGE DAVILA: YOU AS WELL. THANK YOU.
MR. LEACH: YOUR HONOR, ONE MATTER FROM THE GOVERNMENT.
JUDGE DAVILA: SURE.
MR. LEACH: I THINK WE WENT UNTIL 3:00 O'CLOCK ON WEDNESDAY, AND I UNDERSTAND FROM THE DEFENSE THAT THEY MIGHT BE OPEN TO GOING UNTIL 3:00 O'CLOCK ON OTHER DAYS, AND WE JUST WANTED TO SEE IF THE COURT WAS AMENABLE TO ONE ADDITIONAL HOUR EACH DAY. I THINK THAT WOULD AID US IN EFFICIENTLY PRESENTING THE CASE. OF COURSE, WE DON'T WANT TO IMPEDE ON THE EXPECTATIONS OF THE JURORS.
JUDGE DAVILA: THANK YOU. I WAS GOING TO ASK THEM THAT. I DON'T THINK IT'S FAIR TO HAVE THEM THINK ABOUT THAT OVER THE WEEKEND. BUT WHEN THEY COME BACK ON TUESDAY, I THINK I WILL ASK IF WE CAN ADJUST THE SCHEDULE AGAIN. I KNOW THERE MAY BE SOME EMPLOYMENT ISSUES. I DON'T KNOW. MS. KRATZMANN MAY HAVE SOME INFORMATION ON THAT FROM THE JURORS, I JUST DON'T KNOW. BUT I'M GOING TO ASK IF WE CAN EXTEND MAYBE AN HOUR AT LEAST TWO DAYS A WEEK OR SOMETHING TO SEE IF THAT WOULD WORK JUST TO KEEP US ON TRACK.
MR. LEACH: WONDERFUL.
JUDGE DAVILA: IS THAT ALL RIGHT WITH YOU?
MR. DOWNEY: THAT'S FINE, YOUR HONOR.
JUDGE DAVILA: GREAT. OKAY. THANK YOU. THANK YOU VERY MUCH. ENJOY YOUR WEEKENDS.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 2:01 P.M.)