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Re: DewDiligence post# 119748

Tuesday, 05/10/2011 6:16:55 PM

Tuesday, May 10, 2011 6:16:55 PM

Post# of 257251
"Human testing will not be an across-the-board requirement. "It depends on how confident you can be of the absolute sameness to the innovator product," Woodcock said. "There's a spectrum...some will get much closer than others in your ability to characterize them." "


THIS IS BIG. First time, I have heard that human testing of any kind is not mandatory ..Even Momenta was stating some clinical trial maybe needed on biologics.

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