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Re: patientsdeservebest post# 140777

Friday, 09/13/2013 9:49:12 PM

Friday, September 13, 2013 9:49:12 PM

Post# of 346419
Stat. Sig. is not required for BTD. Stat. Sig requires powering using a large enough "n". BTD is designed to help expedite drug development for those that show a benefit in one or more clinically meaningful endpoints. Overall Survival is the most clinically meaningful endpoint in existence. Bavi increased MOS by 60% in 2nd line NSCLC p=.11. That, IMO, is textbook criteria to be granted BTD.
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