Re: DNDN and Dick Pazdur
I agree in part, but I don’t think the issue is as simple as Pazdur’s accepting rigorous data and rejecting wishy-washy data. Rather, I see Pazdur’s MO being to reject the first time around when there is any doubt, and then go overboard to accept the next time. Sort of like the “make-up call” in sports.
With Erbitux in colorectal cancer, for example, the data in the second application (the one based on the Merck KGaA trial) were not much different from the original IMCL data and the second trial still lacked a chemo-only control arm.
Pazdur does not mind being proven wrong – and taking heat from patient-advocacy groups— but he is disinclined to do this more than once for a given drug.
>>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.<<
Strictly speaking, DNDN has not asked for pooling of 9901 and 9902a. They merely want to use 9902a to show that the 9901 survival data were not a fluke. From a practical standpoint, as long as the 9902a survival data are at least OK, it won’t matter whether the 9901 survival data are considered on their own or are supplemented by 9902a – the result will be the same either way.
Hence, pooling per se is not the main Pazdur-related issue. Rather, the Pazdur issues are:
1) Whether Pazdur will make a big deal about the primary endpoint of TTP being missed for the ITT population; and
2) Whether Pazdur will insist on two large trials (9901 and 9902*b*) to support a BLA.
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There is enough complexity and doubt here to fuel strong opinions on both sides. My rationale for being long is that: a) Even with Pazdur, a 9901+9902a BLA has a decent chance; and b) The valuation is cheap even if Pazdur demands to see 9902b.
Still, if Pazdur said he was thinking of taking a one-year sabbatical, I would not try to talk him out of it :-)
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