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Re: attm post# 16096

Wednesday, 10/09/2013 5:01:43 PM

Wednesday, October 09, 2013 5:01:43 PM

Post# of 428912
"Rumors of Briefing Documents focusing on Outcomes study". I doubt that's a rumor...what else would the AdCom talk about all day? Not safety or Efficacy.

Invokana was approved by the FDA on 3-29-2013, it's a DM 2 drug. It was approved despite safety concerns, while waiting for the CV outcomes study due 2017. The lowering of glucose to improve CV outcomes is not proven and more controversial than Lower Trigs, Non-HDL, etc... This is the same Ad Com committee.
In addition, Invokana doesn't have a shadow study like Vascepa's JELIS.

Williams
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