[fullmetal]

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.

I think Theranos actually got initial FDA approval despite the fact that it's never disclosed any of its trade secrets--to the FDA or otherwise.  IIRC, prior incarnations of Theranos's board of directors were filled with political heavyweights, probably aimed at getting regulatory approval rather than providing oversight and technical expertise.

http://fortune.com/2014/06/12/theranos-board-directors/

[fullmetal]

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.

I think Theranos actually got initial FDA approval despite the fact that it's never disclosed any of its trade secrets--to the FDA or otherwise.  IIRC, prior incarnations of Theranos's board of directors were filled with political heavyweights, probably aimed at getting regulatory approval rather than providing oversight and technical expertise.

http://fortune.com/2014/06/12/theranos-board-directors/