Amarin Corp Plc (AMRN)

[HDGabor]

BB-

This post is a good example for my statement, you did not cite any law / regulation to support your view.

The fact the FDA had the Ad Com and made the allegations and then publicly foreshadowed the rescindment of ANCHOR violated the APA. The FDA has guidance documents to address such procedures, not using those documents is arbitrary and capricious.

The AdCom was organized, held acc. to the laws / regulations. FDA "may seek advice from external experts, which may include discussing the SPA submission and the substantial scientific issue at an FDA advisory committee meeting, before the review division decides whether to rescind the agreement". If you could, please mark the exact violation with exact reference to the §.

Had the FDA used the guidance documents a type A meeting would have been scheduled prior to Oct. 16th 2013 ANCHOR rescindment SPA Ad Com

The SPA was rescinded on Oct 29, 2016, AdCom vote was one of the reference (among others) and I am not aware of any law that require a type A meeting before an AdCom. Furthermore,
- How do you know, what is the proof, that the DMEP did not notify Amarin in writing, including the rationale for the potential action (rescindment) and offer an opportunity for a Type A meeting before the rescindment ... Amarin did not raised it, as an issue, in any case ...
- The post rescindment Type A meeting was requested on November 22, 2013, was granted on November 26, 2013 and was held on December 16, 2013

So what is the violation? What is the proof?

Best,
G

ps.: Do you feel the difference between the content of your and my post?