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iwfal

08/19/06 2:35 AM

#737 RE: ocyanblue #731

'The number of patients is based on "randomized" patients not simply signed up to see if they qualify...'

Understood. And given their Jun 05 PR and the legal implications if this weren't the definition they were using I'd agree that this is likely true. But likely is, well, only likely. And no more - remember this is coming from the same IR person who told BTB that the endpoint was PSADT. The implications if the Provost presentation are more accurate are pretty significant for any prediction of the implications of delayed P-11 triggering.

FWIW - Probably 30% of my job is chasing down discrepencies between facts A from once source and facts B from another. The results are often completely different than you might expect. And therefore interesting and important.
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iwfal

08/30/06 7:42 PM

#877 RE: ocyanblue #731

From an IR email:

'The number of patients is based on "randomized" patients not simply signed up to see if they qualify...'

Fairly definite in this case.


Just FYI I just talked to Monique and she directly and completely contradicted this. She said the sequence of events is "Enrollment, hormone therapy, then randomization". And she repeated this even when I asked 3 or 4 different ways. If this is the case then a delay in unblinding until Oct means fairly little. Militating against this definition is:

a) Standard definition of 'enrolled' is 'met the entrance criteria' (one of which is PSA less than 1 ng/ml after LHRH).

b) historical statements by IR (e.g. your response in writing)

c) the fact that the 10K talks of 175 patient 'enrolled' which would be less than 160 patients randomized given historical hormone failure rates.

FYI.