Amarin Corp Plc (AMRN)

[Biobillionair]

BioP-

John-
Amarin released an 8-K that contains the PDUFA delay communication from the FDA, but Amarin doesn’t provide the reason for the delay. Company’s prior to Amarin have provided reason/s for delay; it is unusual to not include this in your notice to Amarin investors. Do you understand this?

Jason

Some investors have expressed that they view it to be unusual. But unusual does not mean wrong. In all such disclosures we aim to be truthful and not misleading. In doing so we seek not to speculate and not to unintentionally and unnecessarily potentially alienate regulatory authorities.

John-
I think I understand...the FDA has not given a reason for PDUFA delay...is this an accurate assumption?

Thanks
Jason

The substance of the notice they sent us they published in the federal register.

Above communications are in order and occurred yesterday. The authenticity can be verified by a trusted almost 3rd party.

The only excuse I see the agency give that could justify delay of PDUFA is the clearly stated primary objective. “The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

https://www.federalregister.gov/documents/2019/09/12/2019-19770/endocrinologic-and-metabolic-drugs-advisory-committee-notice-of-meeting-establishment-of-a-public

It is my belief Amarin could not figure reasoning for delayed PDUFA either and they had to further ask FDA later in the evening. IMO Amarin feels the delay reason is already given in the notice...despite the fact they couldn’t ascertain a reason either until FDA clarification. Amarin did not include the description of doubting efficacy in 8-k....

Is the FDA really going to question the efficacy of R-I results at Ad Com? If there’s an Ad it appears this is the “primary” purpose.... IMO FDA doesn’t have the ability to question SOC....

MRC petition created enough doubt for the FDA to not only question R-I efficacy but also SOC....I don’t see the agency taking the risks of NOT approving labeling...but the decision will be made at the Office of the Commissioner.

I believe approval is likely on or before original PDUFA date...it is based on hunch and above reasoning.

Best of Luck!!!

BB