Amarin Corp Plc (AMRN)

[exwannabe]

I'm amazed that the pharma world agreed to hand such enormous power into the hands of a single individual within the FDA,

That is the same single person who has the ability to approve an NDA. And pharma did not agree, it is a law passed by congress.

And no, the FDA did not illegally moved the bar. They decided the science changed, and therefore the bar needed to be moved. Since the law gives them the sole authority to decide the exact issue, this really is a dead end argument.

One can dispute the science side of the issue. But what went down Wed was fairly clear in that the AdCom supported the FDA view that lowering trigs in this indication was not in itself sufficient to approve the drug.