>> Re: Pazdur comments? by: walldiver (M/Los Angeles area) 04/22/05 03:31 pm Msg: 95669 of 95696
Pazdur is old school (never met a chemo he didn't like). If we take him at his word, Provenge's chances look good. IMO, the jury is still out on whether he can be taken at his word. He has the power to stack ODAC committees with an inordinate number of biostatistician voters.
Here are the upcoming possible FDA hints:
* GTOP progression data release this quarter, possible filing next quarter...which FDA division will review the filing, will it set a precedent for other cancer vaccines, will it go up before ODAC?
* 9902B enrollment target of 275 patients probably will be achieved this quarter...if SPA is amended to include all Gleasons, how favorable will the details be to Provenge's chances?
* 9901 presentation at ASCO in mid-May...will there be additional trial details released?
* 9902A data release, probably late in Q3...if supportive but not stat sig, just how much info will be publicized by DNDN mgmt on 9902A alone and on pooled 9902A + 9901 data?
* PDUFA date for Xinlay is approx Oct 10-12, 2005...the NDA filing for this HRPC treatment is based on pooled progression data...will the FDA approve, perhaps on a Subpart H basis...and what will the decision mean for Provenge? [Also see #msg-6031515 --Dew] <<
I thought Pazdur opposed accelerated approval processes.....how can he possibly help cancer patients by fighting accelerated approval....? With him, you're going to have to have trials which meet endpoints with a doubt....
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