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Re: jessellivermore post# 58159

Tuesday, 09/01/2015 11:54:32 AM

Tuesday, September 01, 2015 11:54:32 AM

Post# of 424150
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
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