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Friday, March 28, 2008 1:56:13 PM
>I still think DD could have given a better example. Satraplatin comes quickly to mind.<
I didn’t cite Satraplatin as an example because the p-value with many zeros turned out to be for a non-standard endpoint (a composite PFS with some novel components).
Avastin (in breast cancer) and Vectibix had many zeros in their p-values for an established endpoint (conventionally defined PFS) and yet the applications still ran into significant troubles along the way to approval.
The impetus for this thread is that a poster on this board likes to cite the many zeros in Proellex’s phase-2 p-value as justification for Joe to use the phrase slam dunk in describing the drug or its clinical trials. My contention is that this viewpoint is naïve. Regards, Dew
I didn’t cite Satraplatin as an example because the p-value with many zeros turned out to be for a non-standard endpoint (a composite PFS with some novel components).
Avastin (in breast cancer) and Vectibix had many zeros in their p-values for an established endpoint (conventionally defined PFS) and yet the applications still ran into significant troubles along the way to approval.
The impetus for this thread is that a poster on this board likes to cite the many zeros in Proellex’s phase-2 p-value as justification for Joe to use the phrase slam dunk in describing the drug or its clinical trials. My contention is that this viewpoint is naïve. Regards, Dew
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