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yellow_bluff

12/21/15 11:16 AM

#67292 RE: Pittkid #67291

I believe both in the case of NCE and in 1A, FDA only wants to kick the can and live in continual delay mode. To them, that is achieving their agenda.

For AMRN, they still have the majority of what they fought to achieve, including FDA's non acceptance of new aNDAs and the right to promote Anchor and DS claim.

I suppose AMRN could ask the NCE judge, Randal Moss to request resolution of NCE by FDA, but so far the company has not. I dont think Watson can ask the judge to tell FDA to hurry up with their NCE decision.

It seems like detente until the chess match moves toward the end game.

I think we will all be waiting for another six months for any real news on any front...

But we can take some solace in the fact that every day that passes before getting to RI interim is another day that likely the drugs RRR goes higher.