Amarin Corp Plc (AMRN)

[Biobillionair]

Shar=

So is this just something you pursued for the message board to make it appear Amarin CEO was incompetent?

CEO is not incompetent...but his strategic counsel might be.

At the same time you are now saying that "The agency has threatened to take action and retract/rescind Priority Review on a whim from Office of the Commissioner." Where did this happen? Where is the proof?

Amarin has a form letter stating the FDA wants to hold an Ad Com in November, and Amarin CEO assumed during CC PDUFA date was going to be delayed until December, I have assumed nothing and the proof is in the form letter. This form letter is submitted with Appeal to Office of the Commissioner.

The FDA still needs to meet their goals as this drug did receive priority review notification.

Yes true, but it appears the FDA has again reset the bar for Vascepa approval and pointing at PDUFA goals in 6 months does nothing to get Priority Review back on track. Nothing should detract from the public safety concern!!!

The pathway to get Priority Review back on track is to appeal decision to “delay PDUFDA” either after Federal Notice in Registry or on 9-29-2019. There is no such thing as a delayed Priority Review; it is a rescinded Priority Review. The appeal is a formal pathway direct to Office of the Commissioner and it requests “final action”. If the Office of the Commissioner denies appeal Amarin’s can take the decision to rescind Priority Review to Court as Arbitrary and Capricious application of PDUFA Regulation regarding “Program Communications”. Amarin must get “final action” from Office of the Commissioner to get Court to accept case.

Again Amarin appeal is based on a clear and present danger the delay poses to cardiovascular patients, the ICER report supports the appeal as well as the REDUCE-IT results.

BB