Amarin Corp Plc (AMRN)

[HDGabor]

JZ was not even at the ADCOM

How do you know it?

We do not know he was there or not. (Note: the following is based on 2013 Meeting Materials of Endocrinologic and Metabolic Drugs Advisory Committee - 6 events inc. Amarin)
The final roster never includes participants from sponsor, sponsor’s presentation was by Regulatory Affairs, Medical Leader, Metabolism Development, etc, never by the CEO and the presenters were determined by the sponsor, not by the FDA.

Could you please tell me ie): How could be the NCE granted with different management?

The NCE is depends on the drug (Vascepa) itself, so new management has to deal with the same drug. The reason for denial was the “active moiety” (based on FDA’s regulation), however the statue contains “active ingredient”. FDA applied the moiety approach since the beginning – it is not new – they applied “new” (never applied before) approach to determine the active moiety.