Biotech Values

[DewDiligence]

BMY:

Doesn't that make this quite different as Ipi passed the primary endpoint?

If BMY were seeking to market Ipi as an adjunct to gp100, there would be no problem insofar as the gp100±Ipi OS comparison was the primary analysis in the phase-3 trial. However, BMY is seeking to market Ipi monotherapy, and the statistical support for this comes from a secondary analysis in the trial.

Despite the above, I think the FDA will probably approve Ipi in the second-line setting, but (as stated at the bottom of #msg-51218113) I would not be unduly surprised if the FDA ends up asking BMY to run a new trial testing Ipi monotherapy vs some comparator.