Amarin Corp Plc (AMRN)

[exwannabe]

Re: Legal action

No, I am not saying the FDA is immune.

I am saying that they will be treated as the "primary court" (sorry, I do not know lawyer speak) that determines the facts.

The courts can rule against the FDA, but they will grant the FDA the ability to do the fact finding. And they will also grant them the ability to make that key decision that the science has changed. This puts a high burden on someone trying to win a case here. They can not simply try to prove the FDA wrong, they will have to prove the FDA was somehow capricious or otherwise not following the law in making their determination.

If there is any hope at all in getting an approval pre R-IT, it will be with cooperation from the FDA. A private "we can not afford to run R-IT to completion" discussion has a better chance than the lawsuit would (though I think it is hunker down time regardless).