Amarin Corp Plc (AMRN)

[ggwpq]

Should FDA grant Vascepa NCE?

IMHO, yes. Vascepa's active moiety couldn't have been previously approved. Otherwise, how can it serves an unmet medical need via the ANCHOR indication. In other words, if Vascepa can treat an illness/disease that none of the previously approved drugs can, by definition, it should be a New Chemical Entity.


When will FDA grant Vascepa NCE?

NCE/NME status is normally decided upon drug approval by the FDA. ANCHOR is a new indication and as a result Vascepa serves an unmet medical need. I believe it's only fair for FDA to start Vascepa's 5-yr exclusivity clock on ANCHOR approval date.

After 2 months of 4g/day Vascepa, it not only makes me healthier but much more optimistic as well.