Replies to post #207557 on Amarin Corp Plc (AMRN)

[rafunrafun]

For god sakes they scheduled an ADCOM after the PDUFA date.

I think the reason for this is because we didn't get the complete story yet, hence FDA asking Amarin to hold off PR'ing it. One of two things will be PR'ed any day now:

1) PDUFA December 28

2) approval of narrow label & PDUFA December 28 for a broader label

Why did we get a partial update? I still think that as a result of the FOIA'ed documents, Amarin learned of upcoming AdCom, approached FDA and FDA confirmed the AdCom, but didn't provide any additional details because Amarin surprised them.

Nothing else makes sense. FDA wouldn't just unsolicitedly inform Amarin of the AdCom without providing further details and ask them not to PR it. Under normal circumstances, FDA would only notify Amarin when they have the complete story and are ok with Amarin PR'ing it.

Additionally, why would Thero throw FDA under the bus the way he did yesterday. He could have said nothing about FDA asking him not to PR it.

[MateoPaisa]

I completely understand your frustration about what appears to be the case. The cold hard fact is that none of us knows the truth (about anything). I respect your prerogative to look at all of this in a negative light. I just refuse to do that. I’m super disappointed at what happened yesterday but not because I’m worried about anything... because I wanted to start cashing in.. which will now be delayed. For me, that is literally nothing more than a bummer. Vascepa will change the world

[raistthemage]

People who think we should play nice with the FDA is going to work are like people who think playing nice with a bully is going to work.