I'd say good thing is we will be done with all the hand wringing Wednesday but if its 6-4 in favor, for example, we need to hand wring through December...
I suspect 8-2, 9-1 or 10-0 in favor but I'm assuming the panel is not predisposed to a negative view and that they will really look at the science as the science makes it an easy vote.
As to vested interest in keeping drug off market, don't see it.
I could see vested interest in getting company on the cheap in BO but getting an Anchor denial would make approval later questionable.
Since Lovaza is going generic soon GSK will be losing Lovaza as revenue stream either way so they wont care. Statins will be prescribed regardless of Vascepa so Statin companies don't care.
BP does not gain anything from Anchor denial, if anything it hurts them as the approval process for trig lowering drugs just went from- prove it lowers trigs to- spend million on a long term outcome study. I don't think Omthera's owners would like that idea. I don't know any BP that would like that idea.
The FDA is asking for the panel to discuss a MAJOR change, the FDA presents evidence in briefing docs that is contradictory and does not really support a major change, it supports a maybe, maybe not at worst case.
AMRN has two things it needs to do in the Adcomm:
1-Show evidence that lowering trigs can reduce heart issues and there is more evidence it does than it does not.
2-Show why the studies that have failed have scientific reason why they did.-This should be easy if they are smart.
The panel will have to decide that lowering trigs does not mean less heart issues-MAJOR change and big leap of science AND that studies that showed no benefit are definitive studies on the subject of Trigs and CHD. Not that niaspin or low level of EPA/DHA don't work but that the studies definitively show there is no benefit to lower trigs in addition to statins.
I would rather be on AMRN's side if on a debate team and not knowing the panel will go with SR when he said based on the panel he only sees one predisposed to a no. If accurate it seems the preponderance of evidence added to the extreme safety should persuade the remaining 9 members to approve.
