Replies to post #207561 on Amarin Corp Plc (AMRN)

[rafunrafun]

But KCSVEN could easily be right as well and they didn’t want to announce a date because of scheduling constraints with ADCOM members.

But what is the big deal about announcing the way they that Amarin did: it's tentatively scheduled for Nov 14 but may be bumped up due to scheduling. Why would FDA even tell Amarin if they're not fully ready yet?

[rafunrafun]

M - I don't like the date of the AdCom. If we get the typical 3 month extension, the new PDUFA becomes December 28. By policy, AdComs must be at least 6 weeks before the PDUFA. That means no later than November 16, which is a Saturday, obviously no good. I assume they don't do Fridays either (because travel day would be Saturday). Therefore November 14 is the latest day possible to fit within the 6 week rule.

Why are they pushing it back so much?

Mateo -

BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study. Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due to scheduling constraints for such a meeting.