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DeepBreath

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Re: johnking29 post# 22001

Thursday, 11/21/2013 9:08:28 PM

Thursday, November 21, 2013 9:08:28 PM

Post# of 426184
johnking29,

I'm sorry but I totally disagree with you. Amarin never asked for the label to include "reduce CVE's". Therefore it stands to reason that the FDA added it. Why? My thoughts are since the other studies failed with outcomes (fibrates, niacin) they are concluding that this to will fail. Why prescribe a drug to lower lipids if it doesn't reduce cve's. During the adcom, it was repeated over and over again...You would only prescribe this medicine in this group (trigs 200-500) to lower cve's. The battle with the FDA is the SPA agreement and the rescission of it due to "new science".
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