Replies to post #5654 on Dendreon Corp fka DNDNQ

[p3analyze]

"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.

[ocyanblue]

"let us have more efficacy data since we have to wait for CMC anyway"

If you cannot weigh the difference between a requirement that can be satisfied with some work and a requirement that can kill a drug forever due to the high cost and long time to run a new trial, then there really isn't much for us to discuss. Believe what you will.