I think Pazdur is bad if you're looking for (or require) a little leniency in the approval process.
Companies looking for accelerated approval will need a relatively robust trial (>100 patients) that is clearly documented (somewhat applies to imclone). No short cuts or sloppiness.
With regards to DNDN, I don't think Pazdur is the type to allow pooling of data from separate trials *if* the company asks for it. He's not that much of a softie. That's just my opinion.
But I don't think he signals an end to cancer drug approval as some fear. Tarceva showed a clear survival benefit and was approved with relative bureaucratic haste. Velcade had a strong accelerated approval package and proceeded through the process without hang-ups. I'm sure he had a glance at those applications somewhere along the line.
It seems as if sponsors need to give Pazdur the impression that he's in control, without making him think that they're trying to slip one by. The one advantage I see for investors is that Pazdur won't let companies run wishy-washy trials. I expect companies to get firm guidance on trial design as well as firm guidance on what is and what isn't a clinically meaningful improvement in the endpoints.
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