"Given Dr. Pazdurâ€™s 'Nothing Gets by Me (Unless It Is Biostatisically Pure Or Sponsored By A Firm With Many Lawyers)' attitude at OOD, he might be exactly what proponents of this portion of the new PDUFA legislation had in mind," Minyanville writes, referring to the new emphasis on safety in the recently enacted FDA reform bill.
"The effect on this for stocks of development-stage biotechs pursuing oncology indications could be significant," Minyanville continues. "Much would depend on who got the OOD job, but there are only a couple of people I could think of who would be worse at the job for oncology patients than Dr. Pazdur. Moving Pazdur out would not immediately make all the oncology drugs with sketchy data viable again, but it might mean late-stage oncology companies might see some positive investor attention again â€“ particularly from â€˜professionalâ€™ investors."
Pazdur, for those who don't know, has been a controversial figure this year, thanks to the Provenge debate. That's the Dendreon prostate-cancer vaccine that an FDA panel recommended earlier this year before two panel members took the unusual step, shortly afterwards, of writing the agency to urge a go-slow approach. The FDA subsquently delayed approval. And Pazdur is mentioned by prostate cancer patients and investors, who have sued the FDA, as allegedly encouraging the panel members to write those letters as part of a Byzantine, behind-the-scenes power play at the FDA.