Amarin Corp Plc (AMRN)

[KCSVEN]

Pretty obvious, the Niacin failure, which we thought was good for a competitor to fail was the nail in the coffin, changed the SPA AMRN had since FDA made it clear they did not have outcome trials at SPA creation point.

The movement to Prove Reduce IT will be successful from Anchor lowering trigs was understated. With the safety profile you would think they would not change things with Vascepa. But they did.

They moved the goal posts and stuck to it. That's what was missed.

AMRM itself missed it, the FAQ on their website says:

In accordance with our Special Protocol Assessment (SPA) agreement with the FDA for the ANCHOR indication, Amarin was required to have an outcomes study substantially underway in order to submit for approval of the ANCHOR indication. The REDUCE-IT cardiovascular outcomes study is substantially underway. In February 2013, Amarin submitted a supplemental NDA (sNDA) requesting approval of the ANCHOR indication. The FDA accepted that sNDA for review and assigned a PDUFA date of December 20, 2013. Consistent with our SPA, and based on our discussions with the FDA, we do not believe the final results of the REDUCE-IT study will be required for FDA approval of Vascepa for the ANCHOR indication, although there can be no assurance that this will be the case. On June 18, 2013, the FDA informed Amarin that it plans to convene an advisory committee on October 16, 2013 to review our sNDA seeking approval for the ANCHOR indication. All regulatory approvals are subject to risks and uncertainties. Investors should review Amarin’s most recent risk factor discussion in its Form 10-Q for discussion of such risks.