Amarin Corp Plc (AMRN)

[Anonymous Fish]

"...still not at all sure how FDA will handle the issue"

I'm not entirely sure either, but going off the FDA's comments at the ANCHOR ADCOM i'd be inclined to believe that it does get approval:

"the critical question which patients care about is ultimately, do the observed changes in lipids and lipoproteins with Vascepa while treated with statins translate into a benefit on cardiovascular outcomes?"

So lets look at the R-IT Vascepa data:

TGs: -22%
non-HDL-C: -4%
LDL-C: +3% (and still well under 80mgs/dL)
HDL-C: +3%
ApoB: -3%
hsCRP: -13%
EPA: +394%

And the above translated into a 25% RRR in MACE, a 28% reduction in stroke, 31% reduction in heart attacks etc etc.

Looks like an open and shut case to me. The only thing that concerns me slightly is the 'fish oils' as a drug class thing. No reason why they should wait for STRENGTH with RRR of 25% and greater in R-IT with no serious adverse side effects, but you never know. Whatever way you slice it Vascepa and EPA are in a class of their own so it's completely unfair/unscientific to compare Vascepa to any fish oil containing DHA.