Biotech Values

[DewDiligence]

BMY:

But the FDA may ask: How do researchers know that the (gp100) vaccine is not toxic, and that this--not effects of ipilimumab--accounted for the difference in survival between the two patient groups?

This question is addressed by the comparison between the two Ipilimumab arms (Ipi monotherapy vs Ipi+gp100), where the hazard ratio was 1.04. If gp100 were significantly toxic and thereby reducing survival in the combination arm, the survival difference between the combo arm and the mono arm would not have turned out to be minuscule.