Amarin Corp Plc (AMRN)

[raistthemage]

Re:Easy. It is not a contract.

That will be decided in federal court (which I think will take the view that the SPA is a contract) and if the FDA thinks they can weasel out under paragraph D

The "director's of the reviewing division" provision says this

http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf

A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has
begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor
should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.


I think it will easily come out that they did not inform Amarin immediately when they decided this. Im almost certain a court will take a dim view of the FDA blindsiding Amarin. I am however not a lawyer.