Replies to post #66355 on Amarin Corp Plc (AMRN)

[Sam81]

M,

Seriously this was discussed lots of times before. Updated or not in the OB, generics are informed by FDA that they can't submit any request, FDA ain't taking any bcz of the suit....Updated in Jan, in Feb or even June...it will happen eventually, meanwhile no one can challenge V for a generic version

[rafunrafun]

Let me translate - you are trying to convince some uninformed that NCE would not be granted in the immediate future and they should sell their shares.

[HDGabor]

M-

I know much more about next week lottery numbers than about what the FDA will do ... :-)

The petition has a high standard (and could be refused):

(1) The petition must begin with a statement that either:
(A) the panel decision conflicts with a decision of the United States Supreme Court or of the court to which the petition is addressed (with citation to the conflicting case or cases) and consideration by the full court is therefore necessary to secure and maintain uniformity of the court's decisions; or
(B) the proceeding involves one or more questions of exceptional importance, each of which must be concisely stated; for example, a petition may assert that a proceeding presents a question of exceptional importance if it involves an issue on which the panel decision conflicts with the authoritative decisions of other United States Courts of Appeals that have addressed the issue.

I do not think that Watson could provide any of them (but I do not know the FDA's view).

Best,
G