Saw this on the Vascepa site: (http://www.buyvascepa.com/vascepa-nce-decision-delayed-till-september-14th/).
"...In addition, a delay may be the reason for the FDA to get all their legal backings in order first before issuing the NCE to Vascepa. Drug companies like GlaxoSmithKline (the makers of Lovaza) may possibly sue the FDA for granting Vascepa NCE status."
As AF said earlier, if the FDA wasn't going to grant NCE they would've said so. They've had plenty of time to determine the moiety issue, so a legal snafu has much more likelihood of being the real hold up. It's highly likely they'd prefer the patent office to defuse the situation.
Has GSK given an indication? Pronova CEO who has the patents and licensed it to GSK has made offensive remarks against Amarin.
Pronova did Combination study--Omacor(same as Lovaza) plus statin.They should have the results by now-- Have they filed any application with FDA for this combination drug?
"offensive remarks" from PRON CEO?
Please document this.
But he has laughed at Amarin repeatedly, as everyone with real knowledge about this in Norway does, AMRN is regarded as one of the biggest jokes ever.
And these people have REAL knowledge about this, in stark contrast to you know-nothings on this board.
Your only "experts" are a fake doc calling himself JL and a hyperactive housewife or something from Seattle who constantly posts publicly known information!