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Re: debrry post# 690

Thursday, 08/17/2006 12:18:13 PM

Thursday, August 17, 2006 12:18:13 PM

Post# of 12660
The factors that go into predicting P-11 success based upon unblinding date:

a) Median time to Relapse to 3 ng/ml when on LHRH for 4+ months - very likely (90% chance) to be less than 9 months given all the literature.

b) Distribution of time to relapse - 95% patients relapse by 3x median (nominal assumption)

c) Enrollment distribution - Assume that 'enrollment completion' mentioned in Jun 05 PR is equal to 'randomization completion'. Assume a r^4 enrollment curve (moderately conservative assumption). Only conflicting data is that Jan presentation on CD54 upreg only talked of 104 P-11 treated patients when there should be about 117 - implying either the CD54 data was more than 6 months old or that the above assumption about the definition of enrollment is incorrect.

d) Number of trigger events required - Industry typical in short trials (median time to event measured in months) is 75% of enrollment without much variation (per at least 6 trials I found). So pick 130 as a moderately conservative number for triggering.

e) Number of censored due to lost/withdrawn... - 10%.

Result - If they unblind in mid Oct or later then there is at least a 50% chance of stat sig. Of course that analysis is only as good as its input assumptions - see above.

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