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Re: croumagnon post# 5654

Saturday, 04/12/2008 6:10:44 PM

Saturday, April 12, 2008 6:10:44 PM

Post# of 12660
"so what you do with one case affect next"
Crou, ocyan is probably right in strict regulatory sense, and for sure I was talking about a hypothetical case that if one were to repeat the doctaxel tax327 trial with merely 98 deaths, then a statistically significant finding would be unlikely. But I have to agree with Rancher on this one too, given that Maha and Scher harped on the small sample size issue over and over again in the AdCom. The faults they found regarding this topic were that "a small sample size study is underpowered", and "the data were too unstable" implying it could turn negative upon additional followup, because in their mind provenge is really as good as saline. So it should be useful to seize the moment and rebuke those two points. It should help the Yes vote to go more easily.

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