Replies to post #215188 on Amarin Corp Plc (AMRN)

[Biobillionair]

FDA could not answer MRC CP, he created enough doubt to confuse enough at the FDA they had to back track Ad Com plans. To further support this Amarin also believes MRC CP as doing harm otherwise they wouldn’t have responded to supplement petition and wouldn’t have filed FOIAs on MRC.

Amarin couldn’t answer why PDUFA was delayed because they are forced to SPECULATE. FDA pointing at primary reason for Ad Com in notice doesn’t definitely define reasons for delay in PDUFA...one has to speculate and Amarin isn’t going to speculate anything in communications with investors.

MRC citizens petitions should all be denied as baseless due to him attempting to sell the document for $32k online....him attempting to sell documents should be filed to all petitions with a request for FDA to deny them.

BB

[ziploc_1]

M...You stated "I believe MRC is either in bed with hedge funds that want in at a cheaper price or BP who want’s to either derail Vascepa or own it at cheaper valuations."

MRC is speaking in a medical language in its CP... that a BP might be more familiar with...rather than in the way that a hedge fund would speak(although a hedge fund could certainly have hired medically experienced individuals to write their CP for them)...I'm putting my money on the employer of MRC being a BP, desiring a narrower label for Vascepa so that the BP could sell its drug with less competition from Vascepa... This gaming of Citizen Petitions is an underhanded trick, if not a criminal one....This whole charade is crying for an investigation by Amarin, or by the SEC, or by the FDA.

I still believe the breadth of the label was the item the FDA wanted more perspectives from an Adcom and this lead to the delayed PDUFA date...The MRC CP was just a side show.

[Flounderguy]

Mellow- would also explain how upset JT was during that call on 8/8. The company was blindsided and all because of a CP. IMO

Regards,

Flounderguy

[sts66]

The new guidance is directed at using CPs to delay generic/biosimilar approvals, not sNDAs - and IMO timing has nothing to do with MCR or AMRN - FDA issued an updated draft guidance around this time last year, and after taking public comments they finalized and released it the other day.

I believe MRC is working for someone, not with someone - he admitted on Twitter a couple days ago that he alone wrote the CPs, and shorted the stock to make money since nobody bought his "research".

Hadn't heard that someone here claims to have a source within the FDA that said "FDA felt bad about the late AC decision" - I'd take that with a grain of salt - this person would fall in a very narrow range of FDA employees, would actually have to be involved in AC decision, else it was 3rd party gossip around the water cooler between two FDA employees/contractors with specific interest in AMRN and the V sNDA.