Replies to post #97107 on Biotech Values

[DewDiligence]

Re: Primary analysis in Ipi ‘020’ study

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.

The evidence is slide #9 from BMY’a ASCO webcast on 7-Jun-2010
(http://www.bms.com/Documents/investors/ASCO_BMS_06_07_2010.pdf ).
The slide clearly shows that Ipi+gp100 vs gp100 is the primary analysis,
while Ipi (monotherapy) vs gp100 is the secondary analysis.

[DewDiligence]

BMY/Ipilimumab:

…it probably is an issue with alpha spend… 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.

That’s just another way of saying that BMY is seeking approval based on a secondary analysis (Ipi monotherapy vs gp100). There is not a separate issue with respect to alpha spend as there would have been if the Ipi+gp100-vs-gp100 primary analysis had missed its p-value cutoff, thereby invalidating the secondary analysis.

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

That’s correct—BMY’s application in the second-line setting will seek FDA approval only for Ipi as a monotherapy.