NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Ex, there is no doubt that when the trial began PFS was the desired path to approval. The problem was pseudoprogression which made PFS an invalid measure. The regulators agreed with the company that the trial could proceed with OS as the goal. OS had previously been one of the goals, but it became primary when patients were deemed to have progressed when in reality they were greatly improving, the cancer appeared bigger but in reality, was dead matter, not an actively growing cancer.

There was a time that regulators wouldn't have supported such a change, they'd have said end the trial and start a new one designed to consider pseudoprogression. Fortunately, the regulators have evolved and trial design can be reconsidered based on what's being found in the trial.

Gary