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Re: Gametheory101 post# 884

Thursday, 08/31/2006 2:15:51 PM

Thursday, August 31, 2006 2:15:51 PM

Post# of 12660
Still, data from P-11 was expected several months ago and the current expectations are now for the data to event in the fourth quarter. It was Gold who said the data would be available in the spring, not IR. Gold knows the trial protocols.

a) This too-early predicting of trigger hitting is a pretty normal mistake for companies to make. I believe it happens because they extrapolate the time to hit the trigger from the blended event rate during active enrollment. But forget about the fact that the event rate tails off after active enrollment is finished. This kind of prediction of trial ending means very little in the world of predicting stat sig since it is not a comparison to historicals.

b) Gold has said repeatedly it makes no sense to talk of P-11 powering because there is no history in this trial population/protocol. So he clearly is not making a comparison to historicals. (Note that there actually is a LOT of historical data - none exactly like what P-11 sees, but as close as most historical comparisons)

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