Thread by @doratki

Good morning from San Jose! It’s 4 a.m. and I’m outside the courthouse for day 2 of Elizabeth Holmes’ testimony in her criminal fraud trial along a 16 other folks who got here before me. I’ll be pounding coffee for the next 5 hours as we wait to get inside. Standby for tweets!

John Carreyrou just arrived and the line has grown to 25 folks. Nearly everyone here is media. T-minus ~4.5 hours until trial starts and my coffee might as well be water at this point.

One kind soul, who may not have actually slept last night, has taken on the duty of keeping a list of newcomers so that there won't be a mad dash to the courthouse doors once the gates open. "Are you media?" she asks No. 26, adding. "Welcome to the shitshow."

It’s 43 degrees and the banter outside the courthouse gates has shifted from complaining about the early hour to complaining about the frigid temperatures. The line has grown to about 35-36 and I can’t feel my right hand.

Courthouse security just opened the gates, and like cattle being herded, the crowd of 51 folks, including myself - mostly media - wait to pass through.

The line is getting longer, and more observers have arrived. Some have been here before and came back to see Holmes on the stand. Others are first-timers, including a corporate law attorney and her younger sister, who read the Carreyrou book & listened to podcasts about Theranos.

I made it into the courthouse and beelined it to the overflow courtroom, where there are power outlets and cushions. The line outside wraps around the side of the building. Safe to say some folks will be turned away this a.m. I regained feeling in my hand, but can't feel my feet.

Others are starting to trickle into the overflow courtroom, so I'm guessing the main courtroom's 35 seats have been filled. By the looks of it from the fourth-floor courthouse window, there are still at least a couple dozen people waiting in line outside.

Holmes is in the courthouse wearing a black blazer and a blue skirt (possibly dress). (Also a correction to my tweets Friday - she was wearing a white blouse* under her blazer, not a white-collared shirt🤦‍♀️) She'd usually wait for trial to start in the courtroom, but not today.

The overflow courtroom is at its capacity. There are many familiar faces, but I'd say over half the people here seem to be observers. No sign of the judge yet. It doesn't look like there'll be lengthy pre-trial arguments this morning before Holmes takes the stand.

Prosecutor Jeff Schenk and Holmes' counsel Kevin Downey just disappeared with the clerk into the judge's chambers. Wonder what's up.

Trial should have begun 30 minutes ago, but there's no sign of the judge, the jury or Elizabeth Holmes. A prosecutor and Holmes' attorney appear to be in chambers with the judge. This tweet is reporting the news that there is no news yet.

A lot of us in the overflow courtroom are scratching our heads wondering what could cause this delay. A plea deal seems unlikely, but would be welcome news to those of us who have lost sleep covering this trial. Maybe another juror was caught playing Sudoku.

Prosecutor Jeff Schenk and Holmes' attorney Kevin Downey have returned to the courtroom, as has the court reporter.

Elizabeth Holmes is the courtroom. Now we're waiting for the judge and the jury.

The jury is in the courtroom and Judge Edward Davila is back on the bench.

The audio in the overflow courtroom wasn't working (of course). But after a brief panic and without the help of courthouse staff, an unnamed good Samaritan figured it out. Holmes is back on the stand.

Holmes' attorney Kevin Downey asks Holmes to compare images of the "insides" of a Theranos device 3.0 and a device made by Tecan. Holmes says they realized if they miniaturized the Tecan devices they could do the same tests.

Holmes says they realized they had problems with the devices when they gave the Novartis demo in Nov 2006 and it took until the end of 2007, or about a year, to finalize Theranos' 3.0 device.

Holmes' attorney points to an email she received in 2011 from Tony Nugent that included an article. She summarizes the article that it says most testing errors happened in "preanalytical" process, and if they could automate that it would reduce the error rate.

The article was titled "Preanalytical variability: the dark side of the moon in lab testing" and it says "lack of standardized procedures for sample collection, including patient preparation, specimen acquisition, handling and storage, account for up to 93% of the errors.."

Holmes' counsel pulls up a mid-2008 email that ex-chief Theranos scientist Ian Gibbons sent Holmes, with a presentation on Theranos' tech. The conclusions included that "performance design goals have been demonstrated" and it's now in "clinical evaluation at several sites."

The presentation also concludes that the "results have been excellent." Holmes says she thought that meant that Theranos was hitting its "design goals," and it tried to partner w/ the DOD's U.S. Army's Telemedicine & Advanced Technology Research Center -- or TATRC.

Holmes said Theranos tried to partner with TATRC in 2008 and 2009, but wasn't successful. Theranos wanted to use the 3.0 device to predict PTSD based on blood markers, test diabetes and test trauma patients for potential infections.

Holmes' counsel pulls up a July 2008 email that Gibbons sent to Holmes with a June '08 presentation. The presentation includes a slide on Theranos' Stanford AML study, which studied blood from cancer patients who were "very sick" and prone to infection, Holmes says.

Holmes says the goal of the study was to determine if Theranos devices could predict sepsis. A conclusion in the slideshow says that "very clear patterns of disease progression, remission and effects of therapies are apparent."

The slide sdays "assya results have been precise," 2/3rds of the way through. Holmes says, "It meant our system was working well." The study eventually was completed and published in a peer reviewed journal, she says.

Holmes says the study concluded that with more frequent tests, they could predict sepsis in cancer patients, but more research needed to be done. Holmes mentions something about Gibbons, but adds she doesn't know what he would think. Prosecutor objects, but the judge overrules.

Holmes says Theranos was working with pharma companies in 2008 and 2009, and her attorney pulls up a slide from a feb 2009 email, which includes "completed successes" of studies w/ GlaxoSmithKline, Pfizer, Celgene, Novartis, AstraZeneca and Merck.

Holmes' counsel asks what "completed successes" means. Holmes replies that it means the study had achieved its goals. There's also a slide that says "ongoing studies," which includes a Celgene study and a Mayo clinic study.

Holmes' counsel pulls up an email Holmes sent in July 2008 to a Novartis chemist Ivan Bottoli on a bone study. Holmes says "it looks like Theranos had completed the validation and I was sending it to Dr. Battoli for review."
I remember it being really good," she says.

For the pathologists out there, the Novartis study looked specifically at IL-6, TNF-a, hsCRP and CRP assays.

Holmes' counsel turns to another study done for AstraZeneca that studied 3 assays - VEGF, VEGFR2 and PGF. The study incorporated Theranos' 3.0 devices with cancer patients in the U.K.

In an April 2009 email, an AstraZeneca scientist asked Holmes if he could present Theranos' "reproducibility" data, which purportedly shows Theranos devices could reproduce certain data done by traditional devices, at a conference.

Holmes' counsel turns to Theranos contract w/ Merck studying the sensitivity of Theranos' devices to do certain diabetes tests. She says the outcome of the study was that Merk said they would work with Theranos, but it never happened.

Holmes says Theranos also started working w/ Bristol Myers around 2005 and did a study with the co in 2008. It also did a study with Centocor to develop PD and PK assays, and Holmes says Theranos devices were deployed for a Centocor study in Belgium.

Holmes' counsel pulls up an email showing that Centicor scientist asked Holmes if the company could share the study's results in a presentation in 2011, and he says in a follow up email that the presentation "went very well."

We were just getting going, but we're taking a 25 minute break. Brb...

While we wait, just curious, if you were facing criminal fraud charges, would you testify in your defense?

And we're back! Holmes' counsel Kevin Downey points out that Theranos contracted with GlaxoSmithKline to study GLP-1 and C-peptide. "I remember them saying they thought our system eliminated the need for a lab," Holmes says.

Holmes says Theranos did work with Schering-Plough, in 2009, which later became Merck. In a March 2010 email, Holmes' assistant wrote Holmes that she had a "great call with Connie Cullen” at Merck, who "said someone in her group reviewed the draft validation from a long time ago"

The email say Cullen wanted the Merck scientists to talk "one-on-one" w/ Theranos scientists, and Cullen "said you should feel free to mention her name to the Merck folks..All in all, it was awesome, I think. Calling her every single morning for the last 3 wks finally paid off."

Holmes says she thought the email meant that Theranos could use Cullen as a reference. Holmes counsel moves on and points out that Theranos also had contracts with Celgene and the Mayo Clinic.

Holmes says Theranos also did a study with Pfizer in Nov 2008 in which they tested cancer patients in clinics and in their homes in remote areas. She says she continued to talk with Pfizer even after the study ended.

In an Aug 2009 email from Craig Lipset, ex-Pfizer head of clinical innovation, wrote Holmes that Pfizer may be interested in doing a clinical trial study w/ Theranos for a new drug and the IL-6 assay. Holmes says the study never happened, b/c Pfizer didn't acquire the drug.

Holmes' counsel pulls up another email from Pfizer exec on Oct 2013 in which the exec wrote Holmes "We are very much looking forward to further interactions.." and "I will follow up separately ..regarding a new 2-way CDA"...

Nothing came from the 2-CDA deal, but Holmes counsel points to a Feb 2015 email in which Lipset wrote Holmes that opportunities arose at Pfizer to potentially work w/ Theranos. One was doing clinical trials in Walgreens and another was testing on lipids and cholesterol.

The judge repeatedly instructs the jury that these emails should go to Holmes' "state of mind" and her understanding of perception of technology, but not necessarily for the truth of the matter.

Holmes agrees that in early 2010, Theranos' engineers believed its systems could run any blood tests. Her attorney points to a Jan 2010 email from Ian Gibbons who wrote "I believe the technology has the potential for rapid expansion of our ability to do general chemistry assays."

Holmes' atty shows slides from a presentation that Gibbons gave Holmes in Feb 2010 that said Theranos' 4.0 "will be capable of performing any measurement required in a distributed test setting. It is envisaged that several distinct measurement technologies will be incorporated."

Elizabeth Holmes' counsel asks her what she understood from Ian Gibbons' Feb 2010 presentation: "I understood that the four series could do any blood test." With that, trial wrapped for the day. We'll be back here tomorrow morning (hopefully) for a full day of Holmes' testimony.

The jury left, but the attorneys are still arguing over whether Holmes' counsel disclosed some exhibits too late. Prosecutor Robert Leach says Holmes' counsel handed them over "the day before" or "the night of," which is too late. Defense says the argument is "not well taken."

Holmes' counsel says he handed over the docs as soon as they could, and the gov't waited until the night before to disclose its exhibits too and it's "the nature of trial."

Before breaking for the day, Judge Davila notes that the jury has again complained that the "keyboard noise has increased" in the courtroom, so he's asking anyone who types loud to go to the overflow courtroom or monitor themselves. And I'm out. ✌️

Elizabeth Holmes took the stand for a second (albeit short) day of testimony, which largely focused on Theranos' big pharma deals and emails to Holmes from the late former Theranos chief scientist Ian Gibbons, who died in 2013. My recap! law360.com/articles/14425…