Replies to post #211014 on Amarin Corp Plc (AMRN)

[Biobillionair]

At this point Amarin has nothing to appeal, but Khushboo Sharma and FDA Ombudsman should be notified of intentions. Amarin should hold a call with FDA Ombudsman ASAP and if the PDUFA date is delayed the appeal should land on the Office of the Commissioner desk the day after 1) Public Notice in Registry of Ad Com and PDUFA delay 2) 9-29-2019, delay PDUFA date. The purpose of the appeal is to not delay PDUFA date, delaying the PDUFA date creates a public safety issue and harms cardiovascular patients. R-I indication SHOULD be ON LABEL 9-28...NOT 9-29 or later.......

Best case is FDA notices Amarin of Ad Com and PDUFA date delay so this process can start.

BB