NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

arain,

I'm certainly not a technical expert, but I believe that something over 60 trial patients remain alive after 5 years in GBM. It's a disease that historically would have killed all but about 15 with the SOC statistically. That's to say I believe at least four times what would have been expected survived in this trial, and perhaps it's substantially over 60, their were over 80 the last time a firm number were reported.

I'm a believer that survival is more important than other goals established when designing a trial. This trial wasn't supposed to be survival based, but was to be based on progression free survival. The problem was what was viewed to be progression wasn't, it was determined to be pseudoprogression, but that couldn't be properly determined until years after the trial began. Extending the trial to prove superior survival was apparently deemed to be the best course to approval by the management rather than ending the trial years earlier, but struggling to show that patients thought to have progressed had actually pseudoprogression.

This is purely a layman's view of what occurred, I only got involved a couple years ago, well after the temporary halt in the trial, and the decision not to require a control in the last roughly a third of the patient in the trial. You should know that most in the control group were permitted to cross over. I believe that all, or very nearly all survivors in the trial will have at minimum received the vaccine on crossing over. If the majority opinion that over 60 remain alive, many well beyond 5 years as the trial began well over a decade ago, is true, I just cannot see the regulators requiring additional proof of a benefit.

Gary