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Replies to #97086 on Biotech Values
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AlpineBV_Miller

06/10/10 8:54 PM

#97107 RE: DewDiligence #97086

What's your source for confirmation BMY didn't do a final SPA amendment to any ipi as the study arm? None of us at ASCO could get anyone nailed down one way or the other. Not saying you're not accurate, just curious as to how you know.

Well, it probably is an issue with alpha spend, which is a different issue than the actual alpha reported. If they spent all p=0.05 on the primary endpoint of ipi+gp100 vs gp100, there is no alpha to spend on the "any ipi" or "ipi monotherapy" analyses they will be asking for approval.

This assumes, of course, that BMY will not be applying for a ipi + gp100 dual approval label.