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Re: Stumbling Bear post# 53206

Tuesday, 07/07/2015 1:29:45 PM

Tuesday, July 07, 2015 1:29:45 PM

Post# of 425250
Thanks for that great summary! FDA attorneys botch their case again - AMRN going to be 2 for 2 - hopefully 3 for 3 if they sue over SPA!

This question alone, a terrific line of thought by the judge, should have ended oral arguments:

Judge said to the FDA,'you have been inviting Amarin to market the drug as OTC, where they could make the claim about "substantial but not conclusive" evidence of reduction in cardio-vascular events. Let's assume that Amarin did that for the Anchor population, but continued to market Vascepa as a prescribed drug for Marine. So you would have the exact same drug for two different indications. Why should the statement be considered truthful and not misleading in one context and not in the other? The FDA didn't have a good answer.

Because there IS no answer, let alone a GOOD one!

The Thought Police: To censor and protect. Craig Bruce

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