Amarin Corp Plc (AMRN)

[biowreck]

Another adcom?....On Thursday, Amarin said it was operating under the assumption that the sNDA will be reviewed over a standard ten months resulting in a PDUFA date near the end of January 2020, and that it expects the regulator with organize an advisory committee meeting of outside experts to deliberate and recommend whether Vascepa’s label should be expanded before the FDA makes its final decision.i

Amarin takes application to expand Vascepa label to the FDA as M&A chatter heats up

by natalie grover — on March 29, 2019 06:16 AM EDT