NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

True. And PFS in a trial like this is for accelerated approval and is a surrogate measure for OS. They are supposed to correlate and they did not correlate. Typically PFS allows accelerated approval with a follow-up trial to confirm OS, the actual gold standard.

PFS is not really good just by itself, though the FDA has allowed it with other measures where it appeared that no new treatment seemed possibly able to extend OS for so many years.

The company extended this trial to show OS and a long-tail. They succeeded.

Also, while they were blinded, they took the further precaution of engaging an outside firm of expert epidemiologists, doctors and consultants who were not involved with the trial and who could not be alleged to have inadvertently been “unblinded” to create the SAP. Also a very smart move as NWBO was blinded and they used outsiders who were blinded. So the SAP was prepared in circumstances one could characterize as effectively double blinded.