Biotech Values

[AlpineBV_Miller]

The issue with ipi approval is not so much the data but whether BMY got FDA agreement for the second SPA edit. The SPA stated the study arm was ipi+gp100. BMY's comments at ASCO indicated they considered the study arm to be any ipi vs gp100. They'll clearly apply for approval for ipi monotherapy and not ipi+gp100.

Unless BMY got approval for this second edit, the stat geeks at the FDA are going to have issues with this shift. I'm not saying the FDA turns the BLA down, just that the stat review section should be interesting.

I've been away for two weeks on the road at AUA/ASCO. Did y'all come to any conclusion whether the ipi label would be limited to HLA-2+ patients (51% of the market) due to the fact these were the only patients allowed in the trial?