Amarin Corp Plc (AMRN)

[HDGabor]

My expectation re. the meeting (based on Doc 73 - "Memorandum & Opinion"):

The parties are, of course, at liberty to pursue further refinements to this disclosure as this litigation moves forward.

They will propose some modifications (if any) to the disclosures.

The Court’s approval today of these communications is based on the present record. Amarin bears the responsibility, going forward , of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading. ... With respect to the reprints of the 13 peer-reviewed scientific publications that address the effect of EPA (Vascepa’s main component) on coronary heart disease, the FDA does not claim that these, viewed separately or together, are false or misleading.... The Court therefore holds, and the FDA does not dispute, that Amarin’s dissemination of these reprints, under the circumstances proposed, would be neither false nor misleading.

/emphasis add by me/

They will set-up a method for inclusion of any additional reprints. ie.: Amarin will send a proposal -> FDA will answer -> yes, OK / No: I guess Amarin will "agree", since the relevant part is already included by the 13 reprints. Any new, will be the cream on the cake.

future course of and next steps in the case

I am not sure, but FDA could declare their intention (ie.: not appeal, but going forward (or not) as a "jury case"), however don't forget it will be FDA intention only, the Goverment could appeal within the 60 days (as they submitted their view after the OA, on 07/27/2015)

Best,
G