Replies to post #211011 on Amarin Corp Plc (AMRN)

[Atom0aks]

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 There is no such thing as a delayed Priority Review; it is a rescinded Priority Review.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

As far as I am aware, the FDA has never rescinded a Priority Review. They can, however, EXTEND (or delay) Priority Reviews. Here are some examples from within the past 12 months (click text for press releases):

20 Nov 2018 Brexanolone (Sage)

7 Feb 2019 Ruxolitinib (Incyte)

4 Apr 2019 Quizartinib (Daiichi Sankyo)

6 Jun 2019 Selinexor (Karyopharm)

Edit: Just in case people think this is a conspiracy by BigPharma, it happens to them too.

6 Sep 2018 Atezolizumab (Roche)

26 Nov 2010 Cladribine (Merck)

[bidmark]

And how long would the appeal process drag on?

[Yoyippie]

Shame on the FDA. With an unmet need and the safety profile has be a shame not to get vascepa expanded on time. What's the negative FDA sees AMRN making money?