Amarin Corp Plc (AMRN)

[Biobillionair]

G & JL- You are both very wrong with your assertions the FDA acted within the confines of the APA.

The above quotes reflect what I believe is factually true..And should have been the correct course of action. However, IMO, the SPA was (appeared to be) flawed because it made the assumption that trig lowering would lower CVD event risk..An assumption that was held by many MDs in the CVD field..If this "assumption" was indeed correct then the "new science" clause in the SPA rules would have required "New" (dated from the commencement of the SPA) scientific evidence that trig lowering would not lower CVD event risk. So at the very least the SPA was poorly constructed and ambiguous.

It’s irrelevant the SPA was flawed, the written process to correct or amend the SPA was not followed. Instead the FDA publicly slandered R-I study with placebo allegation then foreshadowed the rescindment. This destroyed the stock and faith Wall Street has in the results of R-I. You do this Board a disservice for excusing the above FDA actions that violated the APA. Amarin did not prosecute this violation out of fear of further FDA retaliation, IMO an error in judgment. I assure you both if this ITC action does not produce just regulatory actions Amarin is obligated to litigate the US Government for a regulatory “takings” claim that has irreparable damaged CVD stakeholders and Amarin stakeholders. This opinion has been shared with Amarin CEO and Board of Directors.

Amarin can and will win a “takings” claim if the FDA doesn’t act in accordance to the APA.

BB