Amarin Corp Plc (AMRN)

[heysfguy]

Let me add my two cents to your very good post, Birzinho. The issue here may not be a standard "breach of contract" as we know it commercially, but essentially malfeasance. Public officials can be sued for malfeasance.

I think it entirely possible that a judge would likely rule that FDA's determination of "SUBSTANTIAL scientific issue essential to DETERMINING the safety or efficacy of the drug" is not just erroneous but willful. (Especially is improper notification of AMRN is also demonstrated.)

Just recently a judge ruled that FDA's procedures on an ADCOM clearly violated conflict of interest standards...so their administrative track record is not in the greatest shape.

I doubt AMRN would take such a drastic path as a breach/malfeasance complaint. However in order to keep that possibility alive, their leadership may be required to give FDA every opportunity to correct their mistakes. I would not be surprised at all if they went through the entire appeals process, regardless of FDA's record of denials.

Bottom line, I hope NCE and sNDA decisions make this a moot point! Nobody wants this to go to court, if it can be worked out another way.