Replies to post #198527 on Amarin Corp Plc (AMRN)

[Biobillionair]

Perhaps my favorite:

Dr. Hyatt: "Just wait for the event trial to conclude to judge whether the primary endpoint is positive or negative, and then it's a simple decision at that moment in time."

Is anything “simple” for the FDA?

BB

[JJPow]

Let's see the results with an outcomes trial. That's really where the proof in the pudding is This says it all- there is no logical reason for an Adcom, IMO.

[chas1232123]

AF opined on the possibility of an adcom. No surprise, he kept with his pattern of almost exclusively limiting his comment to those which are unfavorable to Amarin. (He suggests an adcom is still very much a possibility, which many people would consider an unresolved risk.)


AF's tweet yesterday:


Adam Feuerstein
@adamfeuerstein

·
13h
Replying to
@sentivcapital
@zbiotech
and
@Sports_bios
From my reading of rules, FDA must give $AMRN 60 calendar days notice for an advisory panel. The Vascepa PDUFA is Sept. 27, so that implies July 29 as the last possible notification date for a panel? Practically speaking, it would have to be well before that.

End of quote.


He was a day off on the PDUFA date. Is his remark about 60 days correct?His tweet was a reply to another tweet that included a statement of FDA policy that the FDA "intends" to convene adcoms at least 6 weeks before the PDUFA date, which would make the cutoff for informing Amarin a week or two ago. Of course, we know the FDA is not rigidly constrained by their intentions, goals, policies, or the law, but it seems very likely no adcom and it seems odd AF almost only comments about Amarin when there's something negative to say. Bizarre, since Vascepa is clearly the biggest advance in decades for the primary killer of humanity, and it's still an investment opportunity of historic proportions IMO as well.


Sincere question: does Stat have a reputation for intentionally fake news? Do we know if they can be paid to slant a story one way or the other? Their coverage of Amarin has been terrible and indefensible. AF and MH have both been given the facts about Vascepa and Amarin and they really don't seem to care about their false reporting.

I don't think there's anything to fear if there were an adcom, but not everyone sees it that way.

[massulo52]

This states it all.....

[HerbieRay]

I agree that Adcom probability is low with the only caveat being whether or not the FDA's doubts re MO are put to bed. Hopefully there wont be any more time wasted on that RED HERRING!