Amarin Corp Plc (AMRN)

[jessellivermore]

HDGabor...

Excellent post...agree with all points..

Quotes:

1) "The FDA (requesting R-IT result instead of ANCHOR), did not set the bar so (too) high, they set the bar on the correct / right level ... to confirm clinical effectiveness clinical outcome is necessary."

2)"I did not see any sign that it was personal against Amarin or requested / pressured (sanctioned) by any entity (commercial or governmental)..

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.

FDA invalidated the SPA on the grounds of three CVOTs...ACCORD, AIM-HIGH, and THRIVE...all of which according to FDA, showed that Trig lowering, did not lower CVD risk...Well to say that was creative on FDA's part is putting it mildly..None of these trials were focused on trig levels and their effects on CVD event risk...All of trials were failures on some level and actual subset of moderately high trigs in one trial did suggest trig lowering might reduce CVD risk..

IMO FDA did use these three trials as a ruse to renege on an SPA that never should have existed..The hard truth is there was/is only shaky proof that lowering trigs will lower CVD event risk and there was/is only shaky proof that EPA would lower CVD event risk in mixed dyslipidemia..And what other reason would there be to give Amarin a label indication for the 35 million patient indication unless it was that EPA lowers CVD event risk...

So like it or not...FDA might have used some leger-de-main and played fast and loose with the facts...but they did the right thing...We need proof, clinical proof that EPA lowers CVD event risk and that proof will be given by R-I...

":>) JL