""a bit longer" would not be something I use to describe the difference between a delay to end of 2007 because of minor CMC issues and a delay to some time in 2009 to wait for the interim data and then resubmit new data."
OK, maybe a bit longer is not the proper term here but the idea remains one and the same. The way I can imagine it happened is along those lines sometime in the late April early May time frame...
The big shot: "Where are we with respect to the Provenge BLA"
The lower level bureaucrat: "well the panel vote endorsed approval but there are some CMC issues still unresolved that we believe will take another year or so. Additionally, you may have read the public letters of Hussein, Scher, and Flemmings arguing vehemently against approval because the efficacy has not yet been demonstrated"
The Padzur Manipulator: "Well, since the CMC issues will take a while to resolve, and since they have an ongoing 9902b trial that will confirm or deny the current questionable efficiency, I think it makes sense to delay approval until both these issues are resolved to a scientific conclusion. Undoubtedly the trials have questionable efficiency so far as has been publicly pointed out by some of our most respected oncologists and statisticians and I think approving at this stage could be a nightmare for the FDA because it could hamper enrollment in 9902b and may result in our approving a drug without the needed efficacy data. What makes sense here is to issue a CR letter requiring a resolution of the CMC issues as well as added efficacy data from 9902b"
The big Shot: " OK, in the interest of sciences, and in order to avoid a major rift within the FDA ranks, let us issue the CR letter requiring further efficacy along with a resolution of the CMC issues..."
Something along those lines may have happened. I suspect that, barring the CMC issues, the arguments of the naysayers would have been weaker and this is why I think the CMC issues may have had a material effect on the final FDA decision...
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