[washingtonismoney]

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...)

[washingtonismoney]

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...)