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DewDiligence

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Re: jbog post# 200195

Friday, 10/28/2016 9:18:29 AM

Friday, October 28, 2016 9:18:29 AM

Post# of 251687
REGN/SNY—CMC issue may delay FDA approval of Sarilumab in RA:

http://finance.yahoo.com/news/sanofi-announces-strong-q3-2016-121400357.html

Manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility, which conducts "fill and finish" activities. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies. Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab on its PDUFA date of October 30, 2016.

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

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