Amarin Corp Plc (AMRN)

[jessellivermore]

Vascepa..the recent history...

(just the pertinent stuff)...

I bought my first AMRN ADRs in Nov 2010. Through this entire period of time I have remained a faithful long.

The ANCHOR trial was a small clinical trial lasting only 12 weeks. The trial was designed simply to determine whether or not 2gms or 4 gms of EPA (AMR101) would lower trigs in the 150-500mg/dl range which was the mixed dyslipidemia (MD) range, without raising LDL-C...The USA market for this cohort was estimated at 35 mil. The thinking at that time was that the available trig lowering drugs (niacin, and fibrates) were not FDA sanctioned because they raised LDL-C..A case where the benefit (trig lowering) was counterfeited by a more serious effect (increasing LDL-C).

An added plum in this case was an iron clad agreement by the FDA (an SPA) that if ANCHOR did indeed lower trigs without raising LDL-C or other safety issues..FDA would give Amarin the label for the mixed dyslipidemia indication..There was one contingency ..and that was Amarin would have to commence an FDA approved CVOT (R-I) and have the enrollment substantially under way (ie 50% enrollment)...

Well ANCHOR fulfilled its promise and the PPS of Amarin rose to as high a $19...R-I enrollment met the 50% in the spring of 2013...and an adcom meeting was scheduled for the fall. Most of us know what happened..THe Adcom
was supposed to be a coronation...But instead FDA led a well orchestrate attack claiming recent medical science called into serious question whether or not lowering trigs was really any benefit in CVD...Subsequent FDA rescinded the SPA on the grounds of "new science" and instructed Amarin it would have to complete R-I and show meaningful benefit for the label award..

Well I was shocked and felt (and still do) that FDA broke their word/reneged
and then used their authority to deny Amarin any chance to combat their argument..Stock holders not in the know (including me) took a terrible beating...

I'm not going to be a hypocrite here because I now own many more shares of Amarin than I ever could if the price had remained at $19 and climbed from there...Also over the years I have come to understand FDA's decision and actually think they did the right thing...FDA's argument broke down to a question formulated by Mary Parks (FDA)...Where she ask the panelists if they felt ANCHOR results would be predictive of a positive R-I trial (I have change the exact wording...to make the question more easily understood.
The answer had to be NO...because ANCHOR was not about clinical outcomes..it was just about lipid levels..The point was FDA had made a serious mistake in formulating the ANCHOR SPA...This might of resulted in a huge patient cohort receiving a drug which really had no clinical evidence supporting its efficacy. FDA did what it had to in a very messy situation..

The rest of the history contains fascinating vignettes about Amarins clashes with the FDA in Federal court...As well as its financial adventures...The rest is largely sitting and waiting for the story to end which should come by this September..

Patience is a virtue...

":>) JL