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12/22/15 11:27 AM

#67393 RE: BioChica #67390

Winning the NCE case? The judge threw out the FDA's initial decision and remanded the case back to the FDA for further review. A win would have been the FDA being told to issue the NCE by the end of the week or face sanctions. The FDA gets a do over. They have nothing but time and my tax dollars to work with and my bet is that they are working every possible angle to justify denying NCE again. Now, for those who say it doesn't matter because they aren't accepting any ANDAs and that effectively grants NCE to Amarin, I would simply say that the issue here is lack of certainty - that nagging little issue that Wall Street banks on.

As for the 1A case, I've seen this tactic many times. The senior partner goes to court, gets the initial ruling and the client, all giddy, gets sucked into to process. There is no significant outcome other than the law firm's billings for the amount of time that it takes to wear Amarin down and agree to settle - you know, the old settle just to settle ploy! And again, that old lack of certainty issue keeps popping up.

Oh, but I'd love to be proven wrong!