Replies to post #199109 on Amarin Corp Plc (AMRN)

[funnygi2]

GG,

I liked these parts, from page 24:

Under FDAAA, an Advisory Committee meeting must be held for all NMEs and original BLAs,
- "someone" was upset earlier today that V isn't considered an NME like Lovaza. Lucky us.

The decision to go to AC should be made as soon as possible, perhaps even before receipt of the application, especially for priority reviews. It should be made no later than the filing meeting for standard reviews;
- filing meeting is day 45 for standard reviews and day 30 for priority reviews. We're well past both.

If an Advisory Committee is deemed necessary, the appropriate Designated Federal Official (DFO) in the Division of Advisory Committee and Consultant Management (DACCM) is immediately notified so that they can begin the scheduling process
- they're already scheduling into September and our PDUFA date is 9/28 if not sooner. Go figure.

[sharinky]

I know the review meeting was yesterday. JT said on Tuesday that the mid-cycle meeting was going to be on Friday.