Replies to post #5644 on Dendreon Corp fka DNDNQ

[rancherho]

p3analyze:
Assuming, as I will, that your statistics are accurate wrt stopping at 98 deaths in the TAX 327 docetaxel trial yielding a calculated p value of 0.20, IMO, that statement would have stopped Hussein and Scher cold at the Advisory Committee meeting, especially if DNDN would have followed up with a Petrylak type analyis of how powerful the combination of Provenge and docetaxel are. The argument would have gone over to trial numbers then, but your statement regarding what would have been a comparison to the standard of care, IMO, would have made a strong impression.

Unfortunately, as you know, IMO, the failed February preapproval manufacturing inspection would ultimately have produced the same result. The results of DNDN's Motion to Dismiss are still not known in the court case. If DNDN loses, discovery should provide a definitive answer to my belief; if not, no one but some at the FDA and a few insiders will ever know for sure. JMHO.

[mouton29]

<<Docetaxel's p-value in the 772 patients clinical trial with way more events than IMPACT merely demonstrated a p-value of 0.01, and an HR of 0.76.

With that type of treatment effect, docetaxel may only demonstrate a p-value of 0.2 at 94 deaths (the events in trial 9901).

So another way to look at this is FDA in essence approved a drug with 20-fold (0.2 vs 0.01) higher chance of being a placebo with much more toxicity, had it been subjected to the same clinical trial condition of 9901.>>

I don't follow this. Are you saying that evidence from a large clinical trial should be rejected because, had a smaller clinical been run and had the results been proportionately the same, the p-value would have been higher? But the larger trial was run, and in this case, a placebo would have produced the results in question in 1% of the cases. What's the relevance of the fact that a smaller trial could have been run?