Replies to post #207717 on Amarin Corp Plc (AMRN)

[sharinky]

He is going off the rails.

[Toddrobertking]

It’s like he is talking to people in the inside. Everything he’s been spewing out of his mouth seems to be coming true so far.

At this point - his theories seem as probable as many we all have.

What a complete mess

imho - he has someone feeding him info from the inside

[massulo52]

Biggest load of bs. Someone is feeding them.

[sts66]

This bit is troublesome - people here are going to lose their minds waiting for publication in the Federal Register that will include the reason for calling for an AC - I checked and he's right, FDA has not published the Agile Therapeutics AC in the Federal Register and it's been 1.5 months since they informed them of an AC - and guidelines call for 6 weeks between AC and PDUFA, Agile only got 2.5 weeks:

(4/) For example, consider the AC meeting date being held just *17 days* before the PDUFA goal date for Agile Therapeutic's Twirla NDA (see pic below). This a non-Program app. And the notice has of course not yet appeared in the Federal Register:

https://finance.yahoo.com/news/agile-therapeutics-announces-fda-advisory-201500199.html

Timing of when agenda should be released:

(5/) Which brings us to the next point--when will the Vascepa sNDA AdCom notice appear in the Federal Regsiter? FDA guidance states "about 6-8 weeks before AC meeting." So, mid Sept/early October it should appear. When it does, we will all pay close attention to the "Agenda."

He also states things I have suggested have occurred - that FDA asked for additional data IMO relating to MO, and what AMRN submitted was big enough to constitute an amendment to the sNDA, which forces FDA to delay the PDUFA, and in this case also caused them to call for an AC.

I know folks will respond with "he's full of BS", but IMO almost nothing in that 25 bullet point tweet is non-factual, and very little of it is opinion - it's accurate info for the most part, except for his claim that R-IT data is highly confounded and the BD's will prove it. Well, it had better be untrue, because if there's a grain of truth to it a CRL becomes a real possibility, meaning FDA forces AMRN to run a MO/statin absorption trial. That means they have to blow up the R-IT SPA, something I just cannot fathom them doing to AMRN a second time - it would be criminal, which may be what Spalding is digging for, proof of collusion between FDA and an outside influence.