Replies to post #57068 on 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

[jfmcrr]

As unacceptable as clearing every bit of promotion with the FDA is the FDA allowing ANCHOR and mooting the whole 9 yards. There is a lot of space between the two positions. Monday meeting and Friday letter to the judge. i'd like to buy a ticket to watch this.....

[ziploc_1]

Hey:

The FDA threatened Amarin with severe fines and jail if they used Anchor info in promoting Vasepa. The FDA considers itself a kind of police force,which also decides what the laws are. They have been tough when they perceive disobedience to their laws. With this mindset, they have not been ready and are not now ready to compromise. Its not just about what issue of what law they consider to have been broken. Its about their position as law maker and enforcer. I do not see the FDA as about to compromise on any of these issues. It will be up to the court to say what is free speech and what are the limits of the FDA in interfering with it.

[sts66]

I agree with every one of your points, and think the FDA/AMRN "love letter" will not meet the expectations of the court - dunno where it goes from there though. AMRN cannot accept the FDA demanding every new communication gain FDA approval before use, as you mention FDA will simply sit on the review(s) and refuse to issue an opinion. But AMRN must toe the line set by the judge and not cross it.