Replies to post #31349 on Amarin Corp Plc (AMRN)

[Biobillionair]

Your link is correct and also the draft guidance used to judge Vascepa. The FDA delayed answering Lovaxa CP and determination of a Vascepa NCE/NME decision to write this "draft policy". That's why they delayed the decision.... This is not my opinion, it's also claimed in Amarin v. FDA NCE lawsuit. What's extremely disturbing is the Lovaza CP reply, Vascepa NCE refusal, and draft guidance do not maintain consistent application of exclusivity definitions or historical rulings...hence by definition capricious.

Have you read Amarin v. FDA?

BB