Replies to post #198483 on Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

Great post!

[ggwpq]

sstyles, thanks for posting. The ADCOM scheduled for 8/7/19 is for GILD's priority reviewed drug with a PDUFA of 10/6/19. R-I's PDUFA of 9/28/19 and still no ADCOM scheduled bodes well for no panel.

[marzan]

Great find, thanks styles! The norm is 6 weeks prior to PDUFA date, they should schedule Adcom and this falls around 15th of August. And FDA should give 55 days advance notification to the sponsor prior to the Adcom date and that falls around June 20th which is well passed already. So out of the hiatus even if they schedule around middle of August, the window of notification has already closed. I think the 3 month end of in house meeting falls on this Friday, I predict we may even get our sNDA approved by next Monday. I am really tired of what the heck they are waiting on this long. We should have gotten our Anchor indication right after Sep 28th once the evidence that V reduces CVD was provided. And they are still sitting on doing nothing but continue to deprive people of Vascepa killing them non stop. Worst they are giving ample time for the shorts to decimate this stock leaving Adcom in the dark.

[wodehouse]

Perceptive post, I like your 'two cents!'

[PSea]

interesting tidbits. i'm in the no adcom camp and was in the PR camp...last year. just dosen't make sense. they ran a cvot trial which isn't designed to tell the FDA how the drug works. they've already had an adcom and safety isn't an issue here. i'd be very surprised.

[AVII77]

Me thinks we are home free with respect to an Adcom.

I agree.

There already was an ADCOM for Vascepa. A very exhaustive one. ADCOM members voiced their concerns and uncertainties at the time. It is well worth folks time to review (or re-review) that.

Vascepa ADCOM Resources

Some relevant transcript comments (admittedly out of full context or sequence):

Dr. Seely: "So I'm really glad an ongoing study is happening, and I will be incredibly thrilled if the results of the efficacy study with outcomes shows that Vascepa, added to a statin, decreases cardiovascular risk. I think it's a really important study. I will be thrilled with those results. But I don't think we have that information today."

Dr. Wilson: "I share Dr. Seely's optimism. Let's see the results with an outcomes trial. That's really where the proof in the pudding is, from my perspective at this point."

Dr. Smith: "And just to expand on that a little bit are the comments again from the advisory committee that the REDUCE-IT study in fact appears to be a well-designed study in a very important patient group, an important study, and one that should substantially help to answer the question before us about whether or not cardiovascular outcomes will be improved with Vascepa."

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."

So, while we can't entirely rule out an ADCOM with 100% certainty, it would seem to me that the FDA can handle the review themselves.

[jessellivermore]

SSt....

Good post...

Re: Adcom....IMO there will be no Adcom because FDA does not want to draw more attention to the 2013 Adcom...THough most of the comments about the 2013 Adcom on this board center around the hypothesis that FDA had it in for Amarin...I believe the Adcom was really about covering up a huge mistake the FDA had made...That mistake being granting an SPA which was a label expansion for lowering CVD event risk for a drug which lowered trigs (albeit not raising LDL-C) but had no hard evidence it could lower CVD event risk...The only way to determine V would lower CVD event risk was an outcomes trial..Hence REDUCE-IT....

I believe the last thing FDA wants is to bring up what happened in 2013..

We shall see...

":>) JL