Replies to post #208896 on Amarin Corp Plc (AMRN)

[Atom0aks]

Right, and if you look at the FDA guidelines, you will see that those dates fall roughly in line with the review cycle (p. 6). In Amarin's case, they probably decided on an AdCom during the late-cycle meeting. Unfortunately, since AdComs only meet twice a year, this meant a November meeting and so Amarin did not get the advance heads up that other companies get.

[sts66]

All you have to do is look back at what happened with ANCHOR sNDA - AC announced 4 months prior to it being held, FDA informed AMRN of the AC 2 months after accepting sNDA but didn't publish it in the FR until two months before the AC (and 3 months after they tell AMRN they're having an AC):

FDA acceptance of sNDA on 4/23/13
FDA informs AMRN it will convene an AC, AMRN PRs it on 6/19/13
FDA publishes AC in the Federal Register on 8/19/13 (note: FR does not mention agenda), see: https://www.govinfo.gov/content/pkg/FR-2013-08-19/pdf/2013-20111.pdf
AC is held on 10/16/13
Debacle occurs