Amarin Corp Plc (AMRN)

[Atom0aks]

TTE,

I think a BIG question that needs to be answered is where were we in the review cycle at the end of July/beginning of August. If my calendar math is correct we should have had our Late-cycle meeting at the end of July. Per the "guidelines" we should have been well past the Mid-cycle review and would of had frequent communications with the FDA via the RPM (Regulatory Project Manager).

My point is:

1, No notice of an Adcom with 74 day letter (Priority Review granted)
2. No notice of an Adcom at Mid-cycle review
3. If my calendar math is correct, no notice of Adcom at Late-cycle review

Those meetings and months of communications with the RPM and no hint of Adcom until 8-8? If the FDA needed more time to review RFI or if there was an added amendment they could have just pushed the PDUFA date back. I think many on the board are correct, the label is for a very large population and its CYA by the FDA. Hence the late Adcom which also extends the PDUFA date. The FDA gets the best of both worlds.....for them.

The FDA could certainly learn from Health Canada when issuing a Priority Review. I can't wait to throw a tweet at Ned Sharpless that Health Canada approved Vascepa for a broad label:)

I had a similar thought as well (my words are bolded) but HDGabor pointed out that a late cycle meeting may not have even occurred,

Quote:
I think the late-cycle meeting has already occurred, which is when an AdCom was decided … the late-cycle meeting would have occurred somewhere around July 28, at which time if they decided to hold an AdCom, it would explain why Amarin was notified of an AdCom on August 8
In this case which is your scenario:

(i) Amarin received the background package for the late-cycle meeting … participated in the late-cycle meeting: was aware of the AdCom decision … BUT … said (by July 31) the AdCom is unlikely and was "surprised" by Aug 8

or

(ii) Amarin did not receive the background package for the late-cycle meeting … did not participate in the late-cycle meeting

or (meanwhile it is not your view)

(iii) the late-cycle meeting was not held yet

This discussion was in regards to HDGabor's timetable in post 210178 (hyperlink)