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Re: DewDiligence post# 53207

Thursday, 10/04/2007 5:05:57 PM

Thursday, October 04, 2007 5:05:57 PM

Post# of 257302
DORB "it presents an unusual case for the FDA reviewers and I’m curious to see how they resolve it."

How come you think DOR's OrBec is an unusual case while DNDN's Provenge was a sure rejection by the FDA for you?

They both filed under the same parameters (missed primary but extended survival) and the DNDN data was a lot stronger than DORB's data... If you think DORB's case is unusual, and thus unpredictable, then for you DNDN's Provenge should have been a slam dunk approval...


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