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HDGabor

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HDGabor

Re: Biobillionair post# 29663

Monday, 06/23/2014 7:41:35 AM

Monday, June 23, 2014 7:41:35 AM

Post# of 426504
BB,

It's not a question for me, that Vascepa is good for the public and should be approved for ANCHOR (safe and better than "labeled" drugs - niacin, fibrates). I just could not find any written / announced procedure (#29625: "no existing, available guideline for lipid-altering drugs and for “when substantial scientific issue essential”") which was breached by FDA. Of course they breached the unworldliness of Congressional Record and the 1997 PDUFA Goals Letter.
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