NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm unclear on whether PFS may have ended with progression diagnosed in some of the earlier patients in the trial, who then went on and lived for several more years. While the PFS that was seen was probably pseudoprogression, were they able to go back and make that determination, essentially changing the earlier data in the trial.

I would suspect that if pseudoprogression had been understood from the beginning, and if a means was determined to differentiate from the beginning that patients had real progression or pseudoprogression, the trial could probably have been much shorter. Perhaps it's just my belief that their was uncertainty in the beginning that required making OS the primary consideration as no one can deny the numbers surviving for 5 years or more. I believe those who are living today may largely be judged as PFS, yet at an earlier stage of the trial they may have been thought to have progressed.

Gary