Replies to post #50998 on Amarin Corp Plc (AMRN)

[declanaidan]

JL Absolutely agree the FDA is presented with an opportunity here to unravel the litany of bad decisions and actions re: AMRN. We know the history and all this s'plaining to do before courts can go away simply by reversing past decisions and grant sNDA, citing on new studies / evidence. Anything else continues the pretzel like contortions of excuses, explanations, denial and continuing litigation (on which they are on the wrong side) and introduction back PR and dangerous precedent for the FDA I would hope they clearly can see this graceful out...but this being the politicized and ungraceful FDA no assurances they will act rationally and correctly, let alone in the interests of a patient population that clearly could benefit.

[gozips]

JL, you mention the likelihood of Judge Engelmayer reading the summary of Judge Moss's NCE ruling. Considering they were contemporaries at Wilmer Hale, I can only imagine of a conversation between the two.

Engelmayer: "I am reading the Amarin complaint and believe the
FDA is full of $%@* !!!"
Moss: "The FDA is full of $%@* !!!"

[MontanaState83]

JL - I totally agree. Amarin needs something solid from the FDA (i.e., Anchor sNDA), not just an "ok-doky, go ahead and share with docs the Anchor trial results". Gotta believe Amarin's legal team is on this same page.

[zumantu]

JL, in the scenario where the 1st offer from FDA is less than what Amarin is willing to take, yet that FDA offer will be made public on pacer . This puts negotiations in a public forum, where we see what the FDA is putting forth.

That is not something either party is used to. A very odd situation for the FDA

[louieblouie]

While prior behavior is prejudicial in criminal cases, I am not so sure that is the case with civil cases. Are there any attorneys out there who can opine?

[sts66]

If the FDA relaxes the rules for Amarin, it is opening up the floodgates for every other company in Amarin's situation. From Amarin's standpoint, can they really believe the FDA will keep their end of the bargain. This sets up a situation where the FDA might later trap the company, claiming Amarin exceeded the agency's instructions and is guilty of deceptive advertising.

I warned about that last week, using it as rationale to state AMRN will not settle out of court - they need a legitimate court decision in their hands so the FDA can't entrap them later if they changed their minds on some handshake agreement.