Sunday, December 02, 2012 4:44:49 PM
Seriously, if bavi continues to show doubling of survival from the SOC in the concurrent Phase II and IST trials and if the Phase II second line data problem can be favorably resolved, it would be unethical to subject a large number of patients to the SOC + placebo in a Phase III demonstration. The new breakthrough pathway to approval is designed for just such instances.
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