Amarin Corp Plc (AMRN)

[HDGabor]

One correction:

I could imagine (but not think) one scenario only when the reason could be important, if the reason is that the rescission at the the time of it was appreciate. As no new information could be submitted during the appeal process JJ decision have to be based on info as of Oct 2013 and could not consider the new studies' result.

Technically, since the SPA is not a mandatory condition of sNDA approval, DMEP could say, that based on the ANCHOR study and new information (studies) became available after the rescission they approve the sNDA.

"Because all FDA decisions on any dispute must be based on information already in the relevant administrative file (§ 10.75(d)), no new information should be submitted as part of a request for reconsideration or appeal. If the sponsor has new information that may affect the original decision, any appeal should be deferred until the new information has been submitted to the administrative file and reviewed by the division. New analyses of data previously reviewed should be considered new information, and therefore should be submitted to the division for review before being submitted as support for an appeal."

The new MARINE and ANCHOR Post-Hoc Analyses came out in May (after rescission and after the decision of ODE II). The new studies' result came out in June after the submission of the appeal to OND (May).