zum...
The way the lawyers are looking at this, the only mutual agreement possible would require Amarin to get the ANCHOR indication, or some important part of it.
Otherwise how can they come to an agreement.
My reasoning is as follows. What the FDA wants is the whole "off label promotion" legal issue to disappear. That includes the PI. That way the FDA can proceed as if little has changed, and come out with its new watered down policy on off label promotion. The PI is strong medicine...in some ways on par with an sNDA...It unwraps the FDA's fingers from around Amarin's throat.
Amarin's options are to continue their lawsuit which has an overwhelming chance of succeeding which would result in the PI becoming a Permanent Injunction, the FDA getting tarred by the second strike, which could focus congressional attention on the agency and ask ...In the immortal words of Vince Lombardy, "What the Hell's going on here?" So make no mistake about it, the FDA wants all this to go away. So a good settlement for the FDA is Amarin drops the lawsuit and agrees to vacate the PI injunction..
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.
The reason why they must have the label expansion is because that and that alone moots the issue of "off label" promotion. Amarin is holding all the cards and there are only two acceptable outcomes..hold onto the PI or get the label expansion. In the first case they continue down the legal road dragging the FDA behind the car. 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..
":>) JL
PS..I should add..The shorts go home and dig their graves..
