Dendreon Corp fka DNDNQ

[nerdseeksblonde]

Many people seem to think the FDA is
nitpicking on stats. However, the issue with taxotere is sill fishing- post hoc cherry picking if you will. There is no "alpha" criterion if you can pick stuff you like. My optimisim earlier was that they could allocate the variance- noise or deviation- to specific causes in a robust and
credible way ( make a causal argument to supplement the statistics) and eliminate many of the stats-only concerns about post hoc analysis. Taxotere synergy could be a fluke, or maybe not, but beating the data to death, not trying to gloss over stuff, was the only way to convince anyone. Why do we need to guess about the survival benefit in provenge-only patients? Aren't they advertising it? Scatter plots, clustering, etc any way to separate drug effects in any specific patients, was the way to go. With the placebo group, they had a way to validate their model beyond some simple summary statistics.

AFAIK, the FDA is looking at the overall evidence, of course in a rather subjective way, and would and did consider evidence beyond statistical hardlines.