Replies to post #220274 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Isaeed, it has been so long ago and a black period that my mind has blocked most of those days out. Can you remember whether the reason for the Adcom then was because of the addition of the CVD wording? TIA

[jessellivermore]

isaeed...

I remember everything...Yes the SPA was predicated on Trig levels..The mistake was a tacit misunderstanding that trig lowering would result in lowered CVD event risk...The confusion was largely due to the fact other modalities that lowered Trigs also raised LDL-C..This had a halo effect on EPA..The ANCHOR SPA was simply about lowering trigs...and nothing about lowering CVD event risk...

But that was an unintended mistake on the part of FDA and that mistake if not corrected would have resulted in AMR101 gaining a label expansion of about 35mil patients (the mixed dyslipdemia cohort) for a drug that had no proven benefit for lowering CVD event risk..In terms of contract law FDA definitely breached the contract...and through no fault of Amarin's...Furthermore FDA used their power to stop Amarin from ever reaching the Federal courts by tying them up in a morass of FDA regulations..One of which was the FDA's right to compel Amarin go through a series of graduated FDA levels..Which was a four corners stall...That would have gone on for years..

None of this had anything to do with FDA being Peed off with Amarin or JZ..This was clearly an FDA mistake..

IMO the FDA would have never allowed the label expansion without a CVOT like R-I...That would never ever come about...I do think if Amarin could have gotten FDA into Federal Court they would have got damages..Probably enough to cover the cost of R-I...

This probably would not have changed the calendar a great deal....

":>) JL

[sts66]

How do you know the "original" ANCHOR sNDA had no mention of CVD reduction in the requested label? AMRN never released the sNDA to the public - I think it was there right from the start, we just weren't aware AMRN was reaching too far. And TG levels for the sNDA were 200-499, not 135-499.