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DeepBreath

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Re: johnking29 post# 22007

Thursday, 11/21/2013 9:48:48 PM

Thursday, November 21, 2013 9:48:48 PM

Post# of 427213
jk29,

Amarin never asked or intended for "lowering CVE" in the anchor indication. The FDA added it. That is the problem. Because of the failed studies, they believe this too will fail for outcomes.

If that is the case, the company should have been notified prior to the Adcom and also in the sNDA letter. It never happened. The FDA set Amarin up to fail.
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