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DewDiligence

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DewDiligence

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Re: jq1234 post# 122394

Thursday, 01/19/2012 8:06:18 AM

Thursday, January 19, 2012 8:06:18 AM

Post# of 252453
FDA issues CRL for BMY/AZN’s dapagliflozin; new trials likely:

http://finance.yahoo.com/news/Bristol-Myers-Squibb-bw-1592330870.html?x=0

The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials.

Dapagliflozin became a longshot for approval on the first review cycle after the FDA advisory panel voted 9-6 against in Jul 2011 (#msg-65362040).

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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