Amarin Corp Plc (AMRN)

[HDGabor]

Yes and no.

Yes: Vascepa could be THE anti-inflammatory drug, but it's a new sNDA.

No: The problem is the FDA determined that a substantial scientific issue essential to determining the safety or efficacy of the drug in the BD on Oct 11 2013. Not in 2010 (Accord-Lipid), not in 2011 (AIM-HIGH), not in February 2013 (sNDA submission), not in March 2013 (HPS2-Thrive). It is fact and not interpretation.

Of course – top of this – their background / reason – is wrong due to several reason (other studies’ target group / type / side effect, etc.) as it’s discussed on this board, so I am not repeat it again.

So the FDA 'has to' protect both the background and the timing, 'as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.'