Amarin Corp Plc (AMRN)

[HDGabor]

r-

Unfortunately questions are only provided 2 days before the Adcom so Amarin needs to make sure that that our key people (like Bhatt) have their schedules cleared in case they are needed.

Meanwhile the final question will be available on November 12 only based on November 14 and the Guidance:

19/09: The FDA explains the meeting’s focus to the sponsor and also may advise the sponsor about the information it may wish to include in its briefing materials

23-30/10: The FDA will send a copy of its briefing materials (or relevant portions thereof), as prepared for public release, to the sponsor to review. … inc. the draft question ***

31/10-04/11: The sponsor should review FDA briefing materials (or relevant portions thereof), as prepared for public release.

02/11: The FDA will post on its Web site both the sponsor’s and the agency's publicly available briefing materials.

Furthermore they will have a late-cycle meeting on or before November 1. ("For applications that will be discussed at an Advisory Committee meeting, the late-cycle meeting will occur not less than 12 calendar days before the date of the AC meeting. … The background package for the late-cycle meeting should be sent to the applicant not less than 20 days before the meeting if an AC is to be held")

***

Prepare AC Meeting Background Package: Questions for the advisory committee and an agenda are prepared and the Advisory Committee Meeting Background Package is assembled in accordance with DACCM timelines

DFO sends FDA’s background package for the AC meeting to the applicant not less than 20 calendar days before the AC meeting

Best,
G