Thursday, February 28, 2008 8:38:08 PM
a) What are the differences in the entry criteria for the ph iii vs the ph iib - if any?
b) For the ph iib subgroup with anemia measurements what were the baseline characteristics relative to the ITT group.
c) What, exactly, is the endpoint for the ph iii?
d) For that endpoint, what was the observed efficacy in the ph iib? The p value? The arm sizes for the subgroup with anemia data? (Note that this is ordinarily what you would see in a published trial)
e) What efficacy did you assume in the powering calculation?
Bad answers to any of the above can indicate a real problem.
Note that I still like the management team here more than most - but as with START, the motto should be "Trust but verify".
Clark
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