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Re: DewDiligence post# 89745

Sunday, 09/02/2012 2:42:18 PM

Sunday, September 02, 2012 2:42:18 PM

Post# of 347009
As previously noted, the ORR data reported in April are final and cannot improve, and hence the study in question failed to meet its primary endpoint and is useless for registration purposes, including accelerated approval.


Roy, if the FDA has embraced irRC, we should be OK. IMO