Amarin Corp Plc (AMRN)

[Biobillionair]

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. The SPA does not require that an outcome study be completed in order for the ANCHOR indication to be approved. As of the date of this update, Amarin has not been informed of any change in the FDA’s agreement on this matter. 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.

I'd like to add...Under a SPA agreement the FDA is required to meet with Amarin if there is a change.

I'm guessing after NOA for Anchor combo on Saturday, AZN may not have been the first BP to make a move.