You say, "And although enrollment can be negatively impacted in many cases, i think that reason is a red herring in this particular example. The enrollment in 02B has clearly picked up, and arguably it will be fully enrolled very soon. At the stage 02B is at, an enrollment delay is not a reasonable argument to nix the possibility of a CU program. "
But, of course, enrollment is not the end of story. The patients need to be kept in the study as well. Would the CU program be closed to people who quit the trial? Is it ethical for the company to treat men who have not enrolled in the trial better than men who have not?
Now, I think it is possible to exaggerate this problem for both approval or CU, because men progress pretty fast -- after 4 months or so, something like 80% of the men on the 9901 placebo arm had progressed. At that point, the men presumably crossover and take Provenge from frozen. Further, at some point, men progress enough so that they would not fit within the proposed label (asymptomatic). So if the FDA is really worried about approval invalidating the results of 9902B, why wouldn't an althernative be, approval conditional on full approval plus, say, 6 months. Conditioning approval on the RESULTS of 9902B (i.e., till 2010) does not seem justified by a desire to maintain the statistical purity of 9902B, such as it is.
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