I've been reading all of the discussions from the DNDN bulls and (let's just call them) non-bulls re: the biostatistical aspects of the DNDN trials vs. FDA rigidity. These discussions seem to ignore the very high level of crossovers in the trials - will this be the case as well when DNDN takes Provenge before any advisory committee? Given the low numbers of placebo non-crossovers, the trials have this Provenge Now vs. Provenge Later comparison baked into the KM curves. How can an advisory committee not take this into account? Without referring to nomograms (sp?), what really can be proved here?
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