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Re:Subprime ‘unicorns’ that do not look a billion dollars by wavefunction on Saturday October 17, 2015 @11:00AM (#10404557)
According to this, they are being forced to seek FDA approval as well as go under review from other regulatory bodies:

http://www.wsj.com/articles/hot-startup-theranos-dials-back-...

I say forced because you made it sound like they had gone out of their way to seek approval when actually they were not.

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