Amarin Corp Plc (AMRN)

[HDGabor]

My view:

They will hold decision on Anchor sNDA until the SPA appeal is ongoing, since if SPA reinstated (it won't) the revision division has to use SPA as the primary basis. Without reinstatement of the SPA, they could evaluate the claim without "restriction" and send their decision.

Amarin has 30 days (deadline: Oct 12) to submit the appeal to the next level. I hope they won't and will send a letter about it to FDA well before the deadline.

After the end of the appeal DMEP could issue the CRL since it's clear they will not approve the application in its present form. They will recommend actions that Amarin has to take to place the application in condition for approval.

1.) finish R-IT and submit a new sNDA based on R-IT's result
2.) resubmit as Accelerated Approval (?)
3.) resubmit as Class1/2 with modified indication / Draft labeling

I guess Amarin requests opportunity for hearing continuously and it will be granted, before - hopefully - or after the CRL.

To exhaust appeals to file suit on SPA (around Q2 2015) is useless since any final ruling could be around mid-2017 as earliest.