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notbrad

01/11/16 12:21 PM

#50375 RE: Rkmatters #50373

That's not going to happen. The FDA is not new to trials which require crossover. Provenge was approved with a placebo crossover upon progression. Corssover impact was more of a concern with Provenge because most patients with prostate cancer typically die of some other cause. But it's not the same with GBM. The historical survival numbers have been well established and crossover impact will be less important. I believe that the FDA will be more focused on the PFS and OS numbers in the treatment arm.