Thread by @doratki

Holmes says she had convos with Pfizer execs after 2009 to counter ex-Pfizer scientist Shane Weber's testimony that Pfizer had no significant dealings w/ the startup after he concluded its tests weren't believable. (ICYMI here's my recap of his testimony) law360.com/articles/14336…

Holmes again says that in 2010 she thought Theranos' 4.0 Edison "could run any test." Her attorney points to an email Ian Gibbons wrote her in Feb 2010 stating “Essentially all [analyte tests] are possible in the proposed system." She thought that meant they could do the tests.

Alright, I deleted a tweet that referred to this as "cross" which was an obv dumb error. (Did I mention I was here at 4:30 a.m.?) This is Holmes direct. Now back to her testimony..

In an Oct '10 email Gibbons sent Holmes & others he wrote: "I think we have demonstrated capabilities fully equivalent to lab methods in areas where we have done assay development. Our immunoassays match the best that can be done in clinical labs and work w/ small blood samples."

Holmes says Gibbons email was saying the data Theranos had demonstrated the devices were fully equivalent to traditional labs.

Gibbons' email goes on stating "We have shown HAI feasibility in less than 2 months." Holmes says that the results were "amazing" and Gibbons' email was saying "the ability to put an assay on our system" quickly "was remarkable." "It was a huge thing," she says.

Holmes says at that point in 2010, Theranos had many of the tools they needed, "but we continued to hire as fast as we could," b/c the company "had to take our formula for our chemistry method" and apply it for retail blood-test lists.

Holmes says Theranos needed to "build the device with the additional detectors to measure markers for this method," and needed to add other tools to run the tests, which was a significant undertaking.

Holmes agrees that in 2010, Theranos had experienced board members, including investor Pete Thomas and Stanford engineering prof Channing Robertson. She asked the board to double the co's staff from 75 to 150 to rapidly expand and launch the 4.0 Edison.

Holmes says "we needed to restructure the whole company to rapidly build this 4 series device and ship it,' but she adds later "We didn’t get the contracts to grow the business fast enough."

Holmes says even after the pharma co's validated tests, Theranos had to reach out to dif groups at the pharma cos and try to find drug trials in the right stage to incorporate the test. It was a "huge number" of dif people and dif orgs that they had to try to work with, she says.

Holmes says an "early goal" of Theranos was to also partner with retail and she reached out to "all of them," including CVS, Walmart, Walgreens, Safeway.

Holmes says in 2010 "Some of them thought we were too early, we were too young as a co that we didn’t have the experience to do what we sought to do. Some of them didn’t want to do it, some of them did" like Walgreens and Safeway.

Holmes atty shows a Theranos slide that says its tests had been “comprehensively validated" over the last 7 years by "10 of the 15 largest" pharma cos. Holmes says it meant that Theranos' system, its chemistries, devices, software, had been tested by the standards of these cos.

Another slide, which was shown to Walgreens execs in March 2010, says Theranos planned to launch the general chemistry influenza and fertility tests in the 4th quarter of 2010. Holmes says she thought it was possible at the time.

Holmes sent Walgreens execs validation reports with Shering-Plough and Pfizer logos. She says "we worked with Pfizer for years to work on a study that develop cancer markers in people. The devices worked, and I thought the data was really good and I wanted to share that w/ them.

Holmes admits that she placed the pharma co, including Pfizer, logos on Theranos validation reports
before sending them to Walgreens, "Because the work was done with these partners and I wanted to convey that."

Elizabeth Holmes says she didn't think Walgreens execs and others would see the pharma logos on the validation reports and assume the pharma cos produced them. "I’ve heard that testimony in this case, and I wish I had done it differently," she says.

Holmes' counsel pulls up Johns Hopkins study for Walgreens that concluded Theranos' tech was "novel and sound." Holmes says "our team was really excited about this. We had sent them binders of material to review before the meeting ... Getting this kind of feedback was amazing."

Some banter b/w Holmes' attorney Kevin Downey and Judge Ed Davila after Downey didn't hear his comment about an exhibit.

Downey: You're so soft spoken I didn't hear you.

Judge: Well, I could correct that.

Walgreens' deal with Theranos included a warranty provision, but Holmes made a comment on their contract asking to exclude a performance requirement provision.

Holmes says she made the comment b/c Theranos " hadn’t even characterized some of the performance requirements. We couldn’t do that bc ...We were still in the development process and we still needed to [do] the studies..."

Even on the stand, Elizabeth Holmes seems to have a hard time avoiding certain vague corporate lingo phrases and words like "characterized" in my previous tweet, which Downey asked her to explain.

Holmes says Walgreens attorneys told Theranos by 2012 that there were too many FDA and CMS regulatory issues to place Theranos' Edison devices inside its stores. Holmes: "Our lawyers had different opinions, but we agreed to do what Walgreens wanted."

Holmes' counsel points to a Feb 2012 email in which Theranos exec Daniel Young wrote Holmes that Theranos devices could do tests for 1,138 CPT codes, and not 116 CPT codes.

Based on a June 2012 email from Theranos chemist Surekha Gangakhedkar, Holmes said she thought Theranos had validated all tests for cytometry assays and "that the assays were sound," that they were good and that they were performing the way that they meant CLIA standards.

Holmes says the assay validation work was "documented in development and validation reports" and done by the scientists in the validation teams. She wrote in 2012 that "At this stage, these templates will be FDA guidance docs effectively."

On the stand, Holmes says "the FDA has the highest standards and we wanted to validate the work at the highest standards."

Holmes is looking at images of the insides of a Theranos Edison 4.0 device and describing its different parts, like it's internal "robot" that moves samples inside, a microscopy system and a centrifuge.

Holmes says Theranos wanted to do all hardware manufacturing in-house to protect its trade secrets and so that the company could control costs and "we thought we could control quality in the best possible way."

In an April 2013 email, Theranos exec Daniel Young wrote Holmes that only 2 of the "top 75 whole blood tests" were still under development, Holmes says all but four were on Theranos' device.

Holmes: "It’s never smooth, there’s always challenges. We were constantly working to ensure that we had the right components in the devices... That meant that were there were a lot of changes" and retailers wanted to customize them, which required system integration & validation.

Trial is taking a 30 minute break. Brb!

And we're back! Holmes' counsel Kevin Downey points out Walgreens and Theranos entered a multi-phase deal in 2012 in which it would roll out devices into stores in the 2nd phase. "We thought that it would be incredibly short," Holmes said of the first phase.

In 2010 emails, exec Daniel Young created a shortlist of commonly used blood-tests that Theranos would offer on its testing menu for Walgreens, based on data from insurance cos' data. He wrote that 102 tests would cover 96% of those tests.

Holmes says she took steps to try to improve Theranos' 4.0 Edison devices to address a "significant hardware issue" in its 1.0 model that would cause blood-testing cartridges to become unsealed in certain conditions.

Holmes says the devices were created to be operated by laypeople to process one sample at a time, and "if you had them in banks in a central lab," you'd need hundreds of people putting cartridges in the devices at once, which would be a "huge project."

Holmes acknowledges Theranos modified Siemens Advia testing devices to run hundreds of small samples. "We did. We made inventions that allowed us to run small samples on those platforms."

Holmes says instead of having hundreds of people waiting to load Theranos Edison cartridges, running tests on modified Siemens "made a lot more sense because you could process all those samples at the same time."

Holmes admits she didn't tell investors or Walgreens that Theranos had modified Siemens devices to run small blood test samples, bc the co's counsel recommended keeping it confidential as a trade secret.

Holmes says a "big medical device co like Siemens could easily reproduce what we were doing bc they had way more engineers than we did," so the co wanted to keep it confidential. It filed a nonpublic patent app, and told the FDA, which said it was have IP protection, she says.

Holmes says in 2013 Theranos lab director Adam Rosendorff established Theranos' criteria needed to be met for validation, and the company planned to offer over 200 tests in Walgreens stores in the fall of 2013.

Holmes says she never pressured Rosendorff or anyone else at Theranos to validate blood-tests and she doesn't have training necessary to validate blood-tests. Holmes says she recalls telling Rosendorff in 2013 to take the time he needed with the tests to validate them.

Holmes says chemist Surekha Gangakhedkar told her in Sept 2013 that "she was stressed and had health issues" so Holmes suggested she take a leave of absence, but Gangakhedkar didn't express concerns about test accuracy. ICYMI, my recap of SG's testimony. law360.com/articles/14228…

Before she quit, Sunny Balwani emailed Gangakhedkar criticizing her team, but Holmes said she would've handled the situation "completely" differently, "because Surekha had worked for our team for years and she was working hard... And this is the wrong way to treat people."

Holmes says they had to delay Walgreens launch b/c they weren't ready, and Theranos paid millions to a marketing and PR firms to help w/ its marketing. But she never approved any marketing materials that she thought were inaccurate, she says.

Holmes says Theranos' board members got Joseph Rago to write a story for the WSJ about Theranos, because they had known him for a long time. She says Theranos' board got to review Rago's article before it was published. (Speaking as a journo, that's not normal, typical or OK)

Holmes says she met with the FDA in the fall of 2013 to share Theranos' business model with the agency in an effort to getting the devices FDA approved. She emailed an FDA staffer that Theranos videotaped the inside of Theranos' devices and shared the video w/ the FDA.

Holmes says she wasn't concerned w/ sharing Theranos' confidential data w/ the FDA, b/c she thought the government would protect it. She also "detailed" for the FDA how Theranos' phase 1 and 2 Walgreens rollout would work, she says.

In an Oct 2013 email to FDA staff, Holmes sent the FDA two documents with lists all tests that have been run on samples at Theranos Wellness Centers in Walgreens, and all the tests planned. Holmes also noted "Some samples collected have been collected via traditional phlebotomy."

Holmes says in the documents, Theranos disclosed to the government that the company was running traditional tests on Theranos machines and commercial devices.

Holmes said she asked George Schultz to join Theranos' board b/c she thought she could learn from him, and he recruited many others to the board, including Henry Kissinger, James Mattis and Dick Kovacevich.

Holmes said in 2013 and 2014 when the Theranos Walgreens rollout begun, the board met four times a year, and board members were paid $150k annually and received 500,000 stock shares. She said Kissinger also got a $500,000 "consulting fee."

Holmes says she discussed Theranos' trade secrets w/ the board in Oct 2013. She says David Boies talked about IP protection and ex-senator Sam Nunn talked about the Coca-Cola formula, which is a trade secret, and the importance of protecting it.

Holmes' counsel points out that Theranos filed dozens of patent applications in Sept 2019, and some of them, which were non-public, described its tech to test blood using small samples on modified Siemens devices.

After the Oct 2013 meeting, Holmes said she tried to recruit board members who had experience in medical cos, and she tapped ex-CDC director Bill Foege and former US senator Bill Frist.

Holmes said she understood in late 2013 that Theranos would roll out its services in thousands of Walgreens stores nationally in exchange for exclusivity. But she says in 2014, their relationship changed when Boots acquired Walgreens and Wade Miquelon left Walgreens.

Holmes admits she knew issues were "coming up" in Walgreens stores and that it had only rolled out Theranos services in 40 stores in 2014, but she didn't know that Walgreens decided to slow their partnership under the Boots leadership.

Holmes says Theranos held an offering in late 2013, but "we received $75 million from Walgreens so we didn’t need the capital." The fundraising round offer stocks at $15 per share, which she says was based off the Walgreens and Safeway deals. Trial is taking a 30 min break. Brb!

We're back! Holmes says the reason Theranos had a short window for its 2013 December offering, b/c of the Walgreens deal and the board approved the offering's closing at the end of the year.

Holmes says she met investor Chris Lucas around 2008 through his uncle, Don Lucas, and the board didn't think she had expertise to build financial projections for Theranos so the board brought in Chris Lucas to do them.

Holmes says Chris Lucas asked about Theranos' deals, but not its technology or biz plan. Holmes says Craig Hall, the largest American Airlines investor at the time, and John Tolbert invested, but didn't reach out to Holmes b/w 2006 and 2013.

Holmes says she was surprised Alan Eisenman invested again in 2013, b/c he wanted more info from Theranos that she told him she couldn't give him and "we had a lot of frustrations around those interactions and I know that he had a lot of frustrations around those interactions."

Holmes says the "slide deck" that they gave to investors in 2014 was an "internal deck," that dates back to Theranos' early years and they added to it each year and showed the decks to "anyone who we were meeting," including hospitals, insurance cos and retailers.

Holmes says "we were hoping we would have investors who would hold the stock for a long time," b/c it was going to take a long time to achieve what Theranos envisioned.

Holmes says she met ex-Cravath partner Daniel Mosley, who was Kissinger's attorney, in 2014 at the BDT conference in Chicago, and she met fund managers for the Cox and DeVos families.

Holmes says Mosley introduced her to other investors like John Elkann (of the Fiat fam), the Oppenheimer family, Alice Walton and Andreas Dracopoulos, Greek shipping heir. "I understood [Mosley] was an advisor to them," she says.

Holmes is now explaining the difference between "brand belief" and "brand behavior" based on a Chiat Day 2011 presentation. (At this point, this testimony is feeling like filler to avoid passing Holmes to the prosecution before the Thanksgiving break.)

Holmes says Theranos ended its deal with Safeway in 2016 due to regulatory and laboratory challenges it faced and Balwani was responsible for sending Safeway Theranos' financial statements/projections.

Holmes' counsel is going through various terms in Theranos' contract with Safeway for the initial launch of the Edison 4.0. He notes that Theranos would have to pay Safeway back if Theranos ended the agreement.

Holmes says Safeway CEO Steve Burd wanted Theranos to make either stand-alone kiosks or built-in cabinets with multiple Edison blood-testing devices, but it was "a whole new product" that was "very complex." Nevertheless, Theranos tried to build it in 2012, she says.

In a Dec 2012 email, Safeway CEO Steve Burd wrote Holmes "It is crystal clear that either the most recently committed [launch] dates ...were far too ambitious, or there have been some overwhelming surprises along the way.."

his email continues..." I also worry that the demands of your core business or the newly acquired DOD biz are consuming resources that would otherwise be committed to launch."

Holmes says she told Burd they weren't launching w/ Walgreens & so Theranos couldn't launch with Safeway either, & there were regulatory q's about what the right thing to do was. But "he really wanted to launch" b/c he said he was retiring soon and it would boost Safeway's stock.

Holmes agrees that she thought she had been transparent with Burd about Theranos' "two-phase" Safeway launch, but he "did not like it," b/c he wanted Theranos' devices in Safeway stores.

When Burd retired from Safeway in May, Holmes says a private equity fund took over the company and although Theranos "could have" launched in Safeway stores in 2013, the new owners didn't pursue the partnership.

Elizabeth Holmes says Sunny Balwani was responsible for making Theranos' financial projections.

Holmes' counsel points to a financial projection Holmes says Balwani prepared in mid-2014 predicting Theranos would make $140M by the end of 2014 & $990M in 2015 in projected income; and it had $168M in deferred revs. Holmes says she thought the $140M included deferred revenue.

Holmes counsel pulls up more projected revenues. Holmes says she thinks Balwani made the projections based on various assumptions, including the number of stores that Theranos services would be in.

Holmes says Theranos did a burn study with the DOD, which was managed by Daniel Young and Dan Edlin, in which burn patients used Theranos blood tests. "I understood that our systems performed well," but they didn't have enough participants, she says.

Holmes says Colonel Melissa Givens told her the military was interested in testing Theranos tech in Africa and how well it could withstand extreme conditions and diagnosing patients in remote areas.

Holmes says the military decided to do a study with Theranos in 2012 in which it transported Theranos' blood-testing devices to Africa to study whether it could withstand extreme conditions, but it didn't test patients.

Trial is breaking for the day, and Holmes' counsel Kevin Downey hasn't finished her direct examination. Trial is taking a long break for Thanksgiving until Monday at 10:30 a.m.

Judge Ed Davila tells the jurors that they might be asked by family members during the break "Gee, what have you been up to?" but they can't tell anyone about the trial or anything about their service. "You just need to walk away, the best you can."

The judge also reminds everyone that we're in the middle of a pandemic and the flu season, so "make good choices," and have a "good long weekend."

The jury left, and the attorneys thanked the court & staff for their work during this "unusual case at this unusual* time." The judge also commends his staff and thanks people in the gallery for not typing so loud today. He adds "I hope it’s not a Zoom Thanksgiving." I'm out ✌️.

The jury deciding criminal fraud charges against Elizabeth Holmes will likely be eating turkey tomorrow, mulling over Holmes' testimony yesterday in which she expressed regret for her mistakes, but defended her actions as well-intended. My recap! law360.com/articles/14430…