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DewDiligence

02/24/11 12:12 AM

#115420 RE: iwfal #115418

…to take advantage of the FDA's weakness of allowing existing standards to be used even if they are clearly asinine.

While you might be able to fool the FDA, you probably wouldn’t fool ODAC, so this strikes me as a poor regulatory strategy for a development-stage biotech company.
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AlpineBV_Miller

02/24/11 2:14 AM

#115425 RE: iwfal #115418

I suspect we'll understand better after MSKCC presents their system for determining bone-based responses at ASCO.