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Replies to #68808 on Biotech Values
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DewDiligence

11/20/08 10:36 PM

#68809 RE: exwannabe #68808

>My understanding was that in practice (i.e., FDA eyes) the 2-sided P value would be rejected for showing a benefit if the curves were not visually clear wrt the treatment arm being on the correct side throughout.<

Do you have a citation for this? My impression is that early curve crossing in cancer trials is quite common, and I have not heard of any cases where log-rank analysis was rejected on this basis alone. T.i.a.
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DewDiligence

11/20/08 10:38 PM

#68810 RE: exwannabe #68808

>Oh yes, it is possible the curves have only some minor early crossing, gets much better at 12-18 months, and a continuation of the 12-18 month effect could provide a winner. And it's possible that biologists will discover a species of airborn pigs.<