Replies to post #55612 on Amarin Corp Plc (AMRN)

[picasel]

ggwpq; Thanks very much and best wishes, this should change the game for us. This quite possibly could lead to a more serious look at who Amarin is and what it has to offer by those searching for the next blockbuster!

[sts66]

Pg 28:

Separately, the Complaint alleged, the FDA’s restrictions on off-label promotion of Vascepa harm Amarin because the FDA had—until recently—“permitted manufacturers of other triglyceride-lowering drugs, such as fenofibrates, niacin, and another omega-3 fatty acid-based drug, to market their drugs for treatment of persistently high triglycerides.”

When did the FDA withdraw the rights of other drugs to market for high TGs? All they did was change the Lovaza label a bit.

Pg 43 - love this bit - judge states what we all thought - that Janet's letter nailed the coffin for FDAs case:

a. The scope of First Amendment protection for a
manufacturer’s truthful and non-misleading promotional
statements under Caronia

In the CRL, the FDA first raised the prospect of a misbranding action against Amarin. But the CRL was unspecific as to the conduct on which the FDA might base such an action. The FDA stated only that that it might consider Vascepa misbranded if “it is marketed” for use by persons with persistently high triglycerides before the FDA had approved such use. From this, Amarin inferred that the FDA was threatening to bring a misbranding action based solely on truthful and non-misleading speech in which Amarin might engage that promoted this off-label use, e.g., statements reporting the results of the ANCHOR study.

In opposing preliminary relief, the FDA has now confirmed that Amarin’s inference was correct. The FDA’s brief, and its responses to the Court’s questions at argument, clarify that the FDA is reserving the right to bring a misbranding action against Amarin where the only conduct on which that action would be based are truthful and non-misleading statements promoting this off-label use