One path I've heard is BMY will apply for accelerated approval on the peptide study and use the DTIC study for full. This isn't available to them since they changed the primary endpoint in the peptide study to OS.
According to people on this board, BMY has said they will file the peptide study data for approval.
I think this will be a fascinating dilemma for the FDA, particularly if BMY didn't file a second amendment to the SPA to convert their alpha spend to any ipi arm from the ipi+gp100 arm. One wonders whether Fleming will be trotted out again by Pazdur to lecture on the evils of unplanned analyses or whether Pazdur will just let this one slide by.
Melanoma patients should figure out whatever the "wrong" side of Pazdur's bed is and station someone there to make sure he gets up on the other side every morning between now and the PDUFA date.
News 
Market Data 
Discover 
