Either way, Epix is getting the shaft big time, and doctors and patients in the US will be denied a very useful new technology for no good reason.
I'd reserve judgement until you see the FDA's side of it. It is possible that the FDA is screwing the company (although I have serious doubts about the reasons you hypothosize). But I have found many instances where the company claimed they were being screwed, but when you see the FDA's side of it you realize that the company was not telling the whole story. That they forgot something important in their protocol (e.g. Genasense which had a bias in when TTP was measured which invalidated their TTP measurement), or that they spun the endpoints that they made (e.g. Citiclone).
One of the problems with calibrating the FDA is that you only get to see the FDA's side of it when the drug is eventually approved or when it makes it as far as an AC.
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