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Federal Criminal Trialtrial-daytrial-dayKevin M. DowneyElizabeth A. HolmesdirectDay 38 - November 23, 2021Elizabeth Holmes addressed Theranos's unfinished platform development, admitted adding pharmaceutical-company logos to reports sent to Walgreens, and explained the limited disclosure of modified commercial analyzers. She also denied pressuring laboratory personnel and attributed financial projections to assumptions in Ramesh Balwani's model.
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Day 38 - November 23, 2021

Holmes Addresses Walgreens Reports, Analyzer Disclosure, and Financial Projections

Judge Edward J. Davila
1Proceedings
1Pages
1Witnesses
2,936Lines
Day 38 of 51
Appearing:

Elizabeth Holmes addressed Theranos's unfinished platform development, admitted adding pharmaceutical-company logos to reports sent to Walgreens, and explained the limited disclosure of modified commercial analyzers. She also denied pressuring laboratory personnel and attributed financial projections to assumptions in Ramesh Balwani's model.

Full day summary

Elizabeth Holmes continued her direct examination, describing Theranos's plans to expand from the 3 Series to a proposed MiniLab platform capable of supporting a broad test menu. She said internal scientific feedback supported her expectations while acknowledging that substantial assay development, hardware, software, staffing, integration, and clinical-validation work remained. On the Walgreens relationship, Holmes admitted placing Pfizer and Schering-Plough logos on Theranos-prepared reports before sending them to Walgreens. She denied intending to suggest that the pharmaceutical companies had prepared the reports and said she wished she had acted differently. She also explained Theranos's shift toward processing small samples on modified commercial analyzers, acknowledged that the company did not publicly disclose that practice and told few outsiders, and attributed the limited disclosure to trade-secret advice. FDA communications were introduced as evidence that Theranos disclosed its central-laboratory model, testing platforms, and associated tests to regulators. Holmes denied pressuring laboratory personnel to approve assays and testified that tests raising concerns were delayed until the laboratory director was satisfied. She also said management had treated Surekha Gangakhedkar's team improperly. The examination concluded with Theranos's rollout assumptions, investor-facing financial projections, board materials, Safeway delays, and Department of Defense projects. Holmes attributed the projections to a model prepared and adjusted by Ramesh Balwani using assumptions about store expansion and other sample sources.

1. Elizabeth A. Holmes — Direct (Continued)

The jury reported no exposure to case information during the recess before Elizabeth Holmes resumed direct examination about Theranos technology, business partnerships, laboratory practices, and projections.

Procedural
Morning Convening and Jury Recess-Exposure Inquiry

No juror reported exposure to case-related information during the recess, and Elizabeth Holmes remained under oath as her examination resumed.

Direct
Elizabeth A. HolmesKevin M. Downey
2930 lines

Holmes described Theranos's 4 Series development, Walgreens and Safeway partnerships, clinical validation, FDA disclosures, marketing, investor communications, and financial projections. She admitted adding pharmaceutical logos to Theranos reports and regretted how that was handled, while attributing limited disclosure of modified commercial analyzers to trade-secret advice.

Highlights

Elizabeth A. Holmes — Directtestimony highlightHolmes described internal scientific feedback that led her to believe the proposed System 4.0 could perform four assay methods and ultimately run any test, while also acknowledging that substantial assay, hardware, software, and hiring work remained.Elizabeth A. Holmes — DirectadmissionHolmes admitted adding Pfizer and Schering-Plough logos to Theranos-prepared reports immediately before sending them to Walgreens, denied intending to imply that the pharmaceutical companies prepared the reports, and said she wished she had handled it differently.Elizabeth A. Holmes — Direct“NO. BUT I'VE HEARD THAT TESTIMONY IN THIS CASE, AND I WISH I HAD DONE IT DIFFERENTLY.”— Elizabeth A. HolmesHolmes denied intending to misattribute the pharmaceutical reports but acknowledged regret after hearing how recipients understood the added logos.Elizabeth A. Holmes — DirectadmissionHolmes explained the decision to process many small samples on modified commercial platforms rather than banks of single-sample MiniLab devices, then acknowledged that Theranos did not publicly disclose that use and told few outsiders, attributing the restriction to trade-secret advice.Elizabeth A. Holmes — Direct“BECAUSE THIS WAS AN INVENTION THAT WE UNDERSTOOD FROM OUR COUNSEL WE HAD TO PROTECT AS A TRADE SECRET, AND THAT IF WE DISCLOSED THAT INFORMATION, WE WOULD LOSE TRADE SECRET PROTECTION. THE BIG MEDICAL DEVICE COMPANIES LIKE SIEMENS COULD EASILY REPRODUCE WHAT WE HAD DONE IF THEY KNEW WHAT WE WERE DOING. THEY HAD MORE ENGINEERS THAN WE DID, AND A LOT MORE RESOURCES. AND SO THE ADVICE WAS TO KEEP IT CONFIDENTIAL SO THAT THERANOS WOULD HAVE THE CHANCE TO PROFIT OFF OF THAT INVENTION.”— Elizabeth A. HolmesHolmes gave her stated reason for limiting disclosure of Theranos's use of modified commercial analyzers.Elizabeth A. Holmes — DirectconfrontationHolmes denied pressuring laboratory personnel to approve assays, said she lacked the training to decide clinical validity, and testified that tests raising concerns were delayed until the laboratory director was satisfied.Elizabeth A. Holmes — Direct“I RECALL TELLING DR. ROSENDORFF THAT WE'LL DO WHATEVER IT TAKES TO GIVE HIM THE TIME THAT WE NEED TO BRING UP THE TEST PROPERLY UNTIL HE WAS SATISFIED WITH SIGNING OFF ON THEM.”— Elizabeth A. HolmesHolmes directly disputed the suggestion that clinical-validation deadlines overrode the laboratory director's approval.Elizabeth A. Holmes — Directtestimony highlightThe defense compared investor-facing financial projections with board materials and Balwani's model; Holmes attributed the projections to assumptions about store rollout and other sample sources and said Balwani prepared and adjusted them.
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