Poorgradstudent...first of all, thanks for posting the conf call transcript here, that was very helpful.
As to your question regarding the CMC section of the BLA, the company has said all along that this will be the rate-limiting step to getting the BLA filed. To me, I believe they mean that it's the last step. However, IMO it looks more and more like the P-11 data will be a parallel "rate-limiting" final step of the BLA. It's taking longer for the number of PSA=3 events to occur than what was previously thought. Originally, upon the enrollment of the final patient they thought that topline data would be ready sometime in 1H 2006. Now, it looks to be sometime in Q4.