[BostonCard]

[quote author=Boston Card link=topic=15866.msg174980#msg174980 date=1475869249]
2) the FDA.  Holmes may have been able to sweet talk a bunch of VC's to part with hundreds of millions of dollars based on hype and talk of disruption, but the FDA is arch-conservative and very skeptical of hype; the greater the "disruption" the more proof they will want that it works as well.  Her strategy was to shoot first and ask questions later on the thought that it is better to ask forgiveness than beg permission.  That didn't go over well with the FDA.

Gotta disagree with you here -- CMS was much more the problem than FDA, at least with Theranos's business model, which relied on building their own labs. For that, getting and maintaining their license was essential. Once the violations were found it was game over for the business model.

(The FDA did make them withdraw use of their "nanotainer" but they could still do testing with larger containers and/or needles...)
[/quote]

Well, if they could do testing with larger containers or needles, then they are basically Quest diagnostics.  CMS was the last nail in the coffin, but FDA came first.  To give you the order of things:

Oct. 16, 2015: Wall Street Journal comes out with its expose
Oct. 28, 2015: FDA orders Theranos to stop using its technology for all but one test.  Given how soon after it came from the WSJ, the FDA had to have been in the process of investigating Theranos long before
Jan. 27, 2016: CMS cited Theranos and said that its testing posed "immediate jeopardy to patients"; the appeal process goes on through April (given CMS' speed, this process likely also predated the WSJ
July 7, 2016: CLIA certificate revoked and Holmes prohibited from running a testing company

The FDA was the first formal regulatory action, and thus had the biggest impact.  But it may be fair to say that FDA was shorthand for "federal regulators".

BC

[BostonCard]

[quote author=Boston Card link=topic=15866.msg174980#msg174980 date=1475869249]
2) the FDA.  Holmes may have been able to sweet talk a bunch of VC's to part with hundreds of millions of dollars based on hype and talk of disruption, but the FDA is arch-conservative and very skeptical of hype; the greater the "disruption" the more proof they will want that it works as well.  Her strategy was to shoot first and ask questions later on the thought that it is better to ask forgiveness than beg permission.  That didn't go over well with the FDA.

Gotta disagree with you here -- CMS was much more the problem than FDA, at least with Theranos's business model, which relied on building their own labs. For that, getting and maintaining their license was essential. Once the violations were found it was game over for the business model.

(The FDA did make them withdraw use of their "nanotainer" but they could still do testing with larger containers and/or needles...)
[/quote]

Well, if they could do testing with larger containers or needles, then they are basically Quest diagnostics.  CMS was the last nail in the coffin, but FDA came first.  To give you the order of things:

Oct. 16, 2015: Wall Street Journal comes out with its expose
Oct. 28, 2015: FDA orders Theranos to stop using its technology for all but one test.  Given how soon after it came from the WSJ, the FDA had to have been in the process of investigating Theranos long before
Jan. 27, 2016: CMS cited Theranos and said that its testing posed "immediate jeopardy to patients"; the appeal process goes on through April (given CMS' speed, this process likely also predated the WSJ
July 7, 2016: CLIA certificate revoked and Holmes prohibited from running a testing company

The FDA was the first formal regulatory action, and thus had the biggest impact.  But it may be fair to say that FDA was shorthand for "federal regulators".

BC