Replies to post #37017 on Amarin Corp Plc (AMRN)

[HDGabor]

Fourth: waste of money

Does not expect different decision within FDA. Court: the result more than questionable, definitely not a slum drunk. The first ruling won't be before 2017 and the final (after 1 or 2 appeal) won't be before 2019 ...

[rafunrafun]

What about your first option, but the FDA are bs'ing and buying time to delay the lawsuit, until either positive R-IT or AMRN goes bankrupt. I really hope that unless something is clearly documented in black and white, AMRN doesn't listen to a thing that FDA says because they've been fucked over by them too many times.

JL, do you feel 100% confident that if we are stopped early for efficacy, FDA will approve V and not come up with bs reasons not to, such as that the placebo was insufficient or argue with the strength of the study or find something else wrong. Because of our past, I think that we must anticipate such and JT must reiterate to the FDA that they invested 100s of millions of dollars and thousands people are participating and if the FDA don't like anything about the study, to speak up now. This is something that attorneys constantly do in court - put it on record that they warned the adversary party of xyz.

[Biobillionair]

Fourth, Amarin is waiting for one more piece to line up before filing the appeal with Woodcock. Woodcock's NCE decision is still cooking...and the company's feeling pretty damn good about their chances.

NCE also gives Amarin new avenues of PDUFA appeals according to Regulations.

This is the most likely senierio IMO.

Will

[Whalatane]

Well of course there is always the 4th reason ...as in complete waste of time .
But I like your 3 options better
Kiwi

[biowreck]

JL, after listening to the sept 16 webcast on reduce it completion, Thero states he will not detail plans for the anchor appeal, although he recognizes the outrage expressed by elected officials, investors, clinicians and patients. He then states Amarin continues to work with regulatory, clinical and legal resources as to a course of action. What I find even more curious than the status of the appeal process, is the FDA's lack of response to the question of the sNDA....as Amarin has made repeated attempts to get a decision on this matter from the FDA to no avail. Why is the sNDA in limbo?