Amarin Corp Plc (AMRN)

[heysfguy]

After reviewing the FDA letters posted by HD (thanks as always!) the agency's rationale appears quite reasonable on the surface. However, JL is right to question the "behavioral" aspects of the FDA's management of the SPA process. I wonder how the AMRN SPA compares to the basis used in the other 9 cancellations. Or for that matter to the 190 or so other SPAs that have not been rescinded. Has the FDA used the same yardstick for all, or are they singling AMRN out unfairly?

No judge is going to argue science in the courtroom but they are experts in analyzing regulatory procedures.

The assumed lack of timely notice by FDA is one thing, but other troubling aspects include arbitrary definition of effectiveness, management of AdCom, and other potentially questionable actions by FDA.

NCE ruling has already exposed a certain level of capriciousness on FDA's part. I don't think it would take the world's greatest attorneys to make some strong points along similar lines in the SPA case. Perhaps AMRN is awaiting rulings and final results of NCE and 1st Amendment cases before making a decision about further litigation.