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io_io

10/11/07 9:34 AM

#862 RE: jshaffer85 #861

<"That's still a secondary endpoint isn't it?">


I would say it is the 50-day GVHD TTF Primary Endpoint but with a Secoondary Analysis.

True, about as good as a Secondary Endpoint.
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drbio45

10/11/07 9:37 AM

#863 RE: jshaffer85 #861

At 50 days treatment failure was p value was .0515.

In the odac panel minds i think they thought the treatment failure rate was .1177. the p value of .1177 was a weighted average of the treatment failure throughout the 50 days so the problems in the first 10 days were actually magnified even though the drug didn't have a chance to take effect.

the important thing is at 50 days how many people were saved from undergoing high dose prednisone, not when they failed.