Amarin Corp Plc (AMRN)

[sts66]

Wait a second - isn't that a BAD example of Adcom timing? I thought the AC had to be scheduled 6 wks prior to PDUFA, at least per FDA guidelines, but this one is only 4 weeks in advance. Yes, found it on the FDA website as "pdufa vi - FDA", which applies from 2018-2022:

b. For applications that will be discussed at an AC meeting, the following
parameters apply:

i. FDA intends to convene AC meetings no later than 2 months (standard
review) or no later than 6 weeks (priority review) prior to the PDUFA goal
date. The late-cycle meeting will occur not less than 12 calendar days
before the date of the AC meeting.

So if that NDA did not receive PR, Intra-Cellular Therapies really got screwed - yup, they did - that NDA was accepted on Dec 11, 2018, so they got standard review, and didn't even get the AC timeline for a PR. Another example of FDA guidelines not being worth the paper they're written on!