Replies to post #32690 on Amarin Corp Plc (AMRN)

[HDGabor]

To anwer to JJ MPC has to held a meeting.

Formal Dispute Resolution:
Appeals Above the Division Level

"In instances when the FDA requires limited discussion with one or more members of an advisory committee or internal or external experts, the FDA should inform the sponsor of this plan within 30 calendar days from receipt of the appeal. The FDA should schedule such limited discussions as quickly as all parties are able to agree on a mutually acceptable date and time. After this limited discussion is held, the FDA should render a decision on the appeal within 30 calendar days from the date of the discussion."