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Re: DewDiligence post# 34460

Monday, 09/25/2006 8:14:22 PM

Monday, September 25, 2006 8:14:22 PM

Post# of 252496
patients with stable disease at the time of unblinding were allowed to cross over.

This is an unusual design - at least to me since the statisticians I work with like uniformity in designing their experiments. How did you find out about this?

That’s true but irrelevant in this case because the PFS endpoint was hit with so much p-value to spare.

What you know post facto does not alter what you should plan a priori. They could have just taken out an insurance. After all an earlier phase-3 on Satraplatin was capped early by the original developer (BMS?) when an interim look was not impressive.

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