Replies to post #17819 on Amarin Corp Plc (AMRN)

[jq1234]

No chance to win a case like this against FDA when all they say is to wait for REDUCE-IT.

[linhdtu]

That I definitely believe is the better way to move forward. The panel may not consider the consequences of their votes (one female doctor mentioned that V can always be prescribed off label as if it is a stand by reason for her voting no).

But the FDA is old hand. It is quite aware of the financial consequence in this case of its decision.

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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).
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[wmjenkins3938]

But you're both right in that Amarin has to be formally notified, a meeting allowed, and possible modifications allowed. If the FDA is obviously wrong or did not follow rules a court will make its own judgment which overrides the FDA's.

[jessellivermore]

"(sorry, I do not know lawyer speak) that determines the facts".

So ex...now you are saying your not the legal expert you were posing at...The FDA made an agreement one which forced AMRN and we shareholders to put up millions of dollars...some of it borrowed with the understanding the FDA would grant the dyslipidemia sNDA if we got the trial substantially underway...and the only things that could break the agreement was the learning of new safety issues that would harm the community..or new scientific evidence that would mean V would be ineffective...
And now the FDA is threatening to break the SPA agreement because two other completely different drugs did not improve CVD outcomes..

The FDA has proven they can not be trusted to do anything honest..AMRN must sue them if the pull the SPA and AMRN has an air tight case..This will go to the Federal courts and will have an easy win..based on First Amendment principles..You see there is some new scientific evidence and it all supports EPA..

":>) JL