Amarin Corp Plc (AMRN)

[sts66]

The key statement here is "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." If Bruno is being truthful- this requirement did not happen. FDA is in clear violation of their binding regulation.

1. FDA is not in violation until the deny ANCHOR.

2. I'm amazed that the pharma world agreed to hand such enormous power into the hands of a single individual within the FDA, who is human, after all, and can be influenced by all sorts of things that are either irrelevant or illegal. Should have been some sort of committee decision instead.

3. The meeting never happened - it's a material event and would have had to be disclosed - so AMRN has clear grounds to go after the FDA is ANCHOR is denied. But does the document state what actions the sponsor can take if the rule is violated?

4. When did Bruno claim it didn't happen, and under what circumstances? Personal communication or publicly? If he said that publicly and was lying (which I highly doubt) he'd be exposed to some seriously bad SEC violations along with legitimate shareholder lawsuits - so my guess is he's telling the truth.

In summary, the FDA clearly and illegally "Moved the bar" on AMRN, breaking their own rules. This will not stand if they deny ANCHOR - I would hope that other pharmas would join in to support AMRN in arguing their case and putting pressure on Congress, the FDA, etc. to honor the agreement, since they all stand to be burned by the same thing happening to them.

Edit: BTW, anyone writing letters or CPs MUST INCLUDE the section of the SPA rules contained in speedrunner's post #18071 - this is critical - makes 100% clear to all recipients that the FDA may be about to violate their own rules - and make THAT point clear too - it's only true if they deny ANCHOR.