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10nisman

09/23/11 3:28 PM

#127233 RE: DewDiligence #127231

Pending FDA biosimilar guidance / U.S. FDA guidance on biosimilars may be imminent
http://www.reuters.com/article/2011/09/23/fda-biosimilars-idUSS1E78M0PN20110923?feedType=RSS&feedName=governmentFilingsNews&rpc=43
As a reminder…the FDA has publicly committed to releasing FoB guidance during 2011: #msg-62941793.

I'm going to go on the record and say MNTA inks an FoB partnership within 3-4 months after guidance is issued.
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HattieTheWitch

09/24/11 6:11 PM

#127291 RE: DewDiligence #127231

I wonder why the FDA has said "weeks or even days" - surely they must have a better feel for timing matters than that?

?