Amarin Corp Plc (AMRN)

[drrc1949]

Hmmm, starts to look interesting! So now I see what BioBill has been up to with his posts. This a-hole, Dr. Coleman, eventually conceded for the record that Vascepa was safe so that should not be an issue. For the FDA to argue new science, they should have followed a specific protocol:

Quote
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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).
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1) No such determination appears to be documented nor was such provided to sponsor
2) No meeting opportunity was provided to Amarin to discuss the scientific issue involved

The protocol wasn't followed so either the FDA is not going to kill the existing sNDA based on new science meaning sNDA should be approved -or- the FDA did not follow its own protocol thereby creating an obvious opportunity for Amarin to initiate legal proceeding.

BioBill, you are one cagey and clever guy, but isn't the legal course still a significant risk?