Replies to post #197771 on Amarin Corp Plc (AMRN)

[HDGabor]

M-

Are you not aware this was before the 74-day letter

Looks like you have to involve more 'expert' …

(I) Are you aware that the '74-day letter' is the Filing Communication?

The RPM also prepares a Filing Communication (the day-74 letter) describing deficiencies, filing review issues (See CDER MAPP 6010.5) and the final review designation.

No 60-day letter exists … the 74-day letter is due by day 60 in case of Priority Review.

The FDA send two letter - in case of Priority Review - if there are filing issues but they are not ready to send to applicant by day-60. In this case they send the “Priority Review Determination” letter by day60 then send the “Filing Issues Identified” Letter by day-74. … Isn't a likely scenario, more likely FDA sent the “No Filing Issues Identified” letter together with “Priority Review Determination” letter.

(II) by JT on June 12

In terms of recent highlights, about two weeks ago, our sNDA was both accepted and we were giving priority review. Number of folks here, since that point in time have been asking will they have an ADCOM? Will FDA have an ADCOM? Will the FDA have an ADCOM? Don't have any answer to that. They have told us nothing, essentially on that particular topic. So, they will have one. They have not said that they won’t have one. … we’ve heard neither yay nor nay on that topic that will silence at this point at this point time and again that’s not surprising

(III) If the FDA sent any type of notification (since June 12): yes … no .. maybe (about AdCom) it is a material information … the Co disclose it immediately.

Best,
G