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DewDiligence

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DewDiligence

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Re: DewDiligence post# 106479

Thursday, 10/20/2011 2:16:52 AM

Thursday, October 20, 2011 2:16:52 AM

Post# of 253127
SNY reports additional Aubagio (f/k/a teriflunomide) data from phase-3 TEMSO study in RRMS and reveals that the NDA has been accepted by the FDA for review:

http://finance.yahoo.com/news/Oral-Therapy-Teriflunomide-prnews-1797152570.html?x=0&.v=4

Assuming a standard review (the PR would presumably have said so if a priority review), the PDUFA date is in June 2012. The PR above says SNY intends to submit a European MAA in 1Q12, which could allow EU approval in 1H13.

Aubagio is one of the various oral threats to Copaxone, so it bears watching for MNTA and TEVA investors.

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

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