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walldiver

10/03/06 7:54 PM

#1115 RE: io_io #1114

Since the control arm in all three AIPC trials was placebo, then any approved label should state that survival benefit was the basis for approval.

If Provenge had been trialed vs Taxotere with both noninferiority and superiority endpoints, then any approval label in this hypothetical case would depend on the relative performance vs Tax.