Replies to post #58159 on Amarin Corp Plc (AMRN)

[Invest83838]

JL, Must Be Some Very Nice Mushrooms


"In the second case FDA does what it should have in 2013, the right thing, and grants the label expansion. Amarin drops the lawsuit, the two kiss and make up...the morons at FDA keep their jobs...and we shareholders go to sleep with visions of sugar plums dancing in our heads.."

LOL!

Well, let's hope dreams come true.

[Whalatane]

JL agree with some of the following


The problem is the PI the way it stands is the next best thing to a label expansion and if they give this up, they are back to where they were before the PI and at the mercy of the FDA, who might bring a mis branding charge against them. Amarin needs a place of greater safety. So without a label expansion, I just not see them vacating the PI, or discontinuing the lawsuit, and despite kiwi's abiding faith in the FDA's "first team", I can not imagine the FDA prevailing in the lawsuit.

I agree that AMRN will not want to give up the preliminary injunction without significant concessions from the FDA .
However I do not expect that concession to be full approval of the Anchor indication.

I suspect, along very simple lines ...the FDA will say " go ahead and inform MD's that current studies indicate reduction in risk is associated with lower TG's ApoC 3 etc and that Vascepa can lower these risk markers based on Anchor data.
BUT ...we do not want to see your Pawn Star guy on national TV saying Vascepa can lower your risk of a heart attack."

JMO
Kiwi

[sts66]

What the FDA wants is the whole "off label promotion" legal issue to disappear.

Even if they somehow settle with AMRN and the PI disappears FDA still has to address the 21st Century Cures Act and it's off-label drug promotion section - FDA cannot escape addressing this issue forever:

http://www.lifescienceslegalupdate.com/2015/05/articles/legislative-developments/proposed-21st-century-cures-act-addresses-off-label-promotion-issues-for-drugs-and-devices/

The present version of the 21st Century Cures Act specifies that, within 18 months of its enactment, the Secretary of Health and Human Services “shall issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.”