Replies to post #268536 on Amarin Corp Plc (AMRN)

[ORBAPU]

I agree that demonstrating bioequivalency for MARINE should be straightforward. So the question is, will the FDA require bioequivalency for REDUCE-IT assuming a higher standard must be met? It would seem FDA would/should insist on a label restriction not for use in treating CVD if the generic drug hasn’t demonstrated R-I bioequivalency.