Biotech Values

[DewDiligence]

>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.