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Re: DewDiligence post# 46765

Tuesday, 05/15/2007 10:30:07 PM

Tuesday, May 15, 2007 10:30:07 PM

Post# of 257253
On POTP, Dew, you have understated the alpha allocation to the interim look by a full 250%, it is .005, not .002.

"The Company expects to report on the committee's recommendation to continue the trial or stop the trial either due to reaching statistical significance (p less than 0.005) or futility. "

Note that the total alpha is a skootch higher than .05 (.0498 + .005 = .053). You never know when .003 will come in handy. I mean, clearly a trial that misses with its
primary endpoint by that much would be rejected by the FDA. (and no, I am not bitter, I just can't help myself).

On a different note, is your statement about the limited information obtained from an interim data look dependent on the interim look being unscheduled? Because my recollection is of press releases going into more detail for some interim looks, but I have not taken the time to look.

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