NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I wasn't involved back then and don't know anything about what went on, I'm purely using my judgement that they made a decision to push O/S rather than PFS which lengthened the duration of the trial.

Everything I'm seeing says the vaccine's doing great it terms of O/S. Because early on pseudoprogression was thought to be progression, my thinking was that the PFS data would have been confused because of the diagnosis of progression which was actually pseudoprogression. I would certainly think anyone alive today after much more than say 6 or 7 years would be recognized as having pseudoprogressed, rather than progressed, even though originally progression may have been called. I don't believe the same for those who entered the trial in the first few years after it was initiated, who may have been viewed as progressing after a matter of months, but lived for 3 years or more.

I don't believe anything was wrong with what the company did, but I do believe they reacted to what they learned while in the trial. The new SPA is what I believe they needed to have the trial judged based on what was learned even though the numbers living alone should be evidence of the vaccines efficacy. Sometimes the FDA cannot see the forest through the trees.

Gary