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Re: DewDiligence post# 100022

Wednesday, 07/28/2010 2:48:12 PM

Wednesday, July 28, 2010 2:48:12 PM

Post# of 257269
No, Dew, that's NOT my whole argument. My argument (and, I think, SNY's argument) is actually two-fold: (1) Requiring immunogenicity data is ipso facto a request for safety and efficacy data (I think Rockrat and Mouton may agree on this point, although you don't) and (2) The FDA by requiring such data had to do a "comparative assessment" which forced them to use SNY's proprietary data and, thus, breached FDA's own statutes.



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