Thursday, February 28, 2008 8:08:58 PM
".. he was clearly talking about an abstract regitstrational trial and not the actual design."
correct. from a clinical perspective we know proellex is quite effective at stopping menstrual flow, and the outstanding concerns relate to its chronic effects on the endometrium - specifically will the withdrawal bleeds be tolerable and timely, and will there be any precancerous or cancerous transformation. with acute administration these concerns are for the most part eliminated - hence my confidence in such a trial.
now from a statistical perspective did i think the placebo arm would have 15 pts back when i posted? no. do I now think this placebo arm poses an inordinate risk? I'll leave that to the statisticians on this board, except to point out there is usually not much of a placebo effect on a hard endpoint like this - in fact, much like an antiviral trial, expectations are that the placebo arms will continue to trend negatively - magnifying any positive efficacy signal in the tx arm
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