Replies to post #198766 on Amarin Corp Plc (AMRN)

[MedResCollab]

please show me any mention of 55 days from FDA's website / policy. -Rafun

See pg 17 here:

https://www.fda.gov/media/75436/download

However, it’s aged guidance, and not quite applicable to apps in PDUFA V and VI programs.

[Biobillionair]

Here:
https://www.fda.gov/media/75436/download Page 19

For open advisory committee meetings that involve sponsor-prepared briefing materials, approximately 55 business days before the meeting is scheduled to occur, FDA intends to notify a sponsor that an advisory committee will consider an issue that is directly relevant to the sponsor.

The 55 day notice is so Amarin can prepare for reasons why Ad Com need.

Amarin has not been notified.

Ad Com must occur 6 weeks before priority review. 21st Century Cure Act is mostly about timely FDA communications...several Ad Com references.

BB