Amarin Corp Plc (AMRN)

[bogatie]

This all comes down to one question: does FDA make CaPre run a CV trial? Does biometric data replace an outcomes trial? Amarin is making it very clear that this is EPA as the mechanism and not trig lowering. Better hope future FDA thought is the same - i.e. if they change their position they could open the door to other EPA / DHA mixtures. EPANOVA's trial will be the key. If that has similar results to Vascepa, then FDA might say that trig reducing is part. If their results are worse, then FDA would likely attribute success to EPA and failure to the DHA muddying the active ingredient. If EPANOVA is not at 25% RRR, it would be totally hypocritical of the FDA to start giving any Omega 3 a CV label based on anything other than an outcomes trial.