Biotech Values

[mouton29]

DNDN: If reduction in risk of death is say 18-20% instead of 22% does the FDA approve it? [/quote] 20% perhaps, 18% no (IMO).

I believe the primary endpoint is overall survival. Are you saying that even if there is a statistically significant increase in overall survival, the FDA will reject Provenge on the ground the difference is not clinically significant, if the hazard ratio is 18%? Or are you saying that if the hazard ratio os only 18%, overall survival won't be statistically significant and the primary endpoint won't be met and therefore the FDA will reject?