NorthWest Biotherapeutics Inc (NWBO)

[Ready4bluesky]

"this trial has been enrolling off and on for nearly ten years now. If this were that big of a problem, then they would have hit the requisite number of events a long time ago and would have re-designed the trial.

I'm not so sure. First, the enrollment ramp has been such that many of the 300+ were enrolled in the last two years. Second, have you forgotten that they did re-power the trial? They knew in 2014 that the PFS hurdle was going to be very close and lowered the bar.

"But no, that is not what happened. They were getting so good of results from the Phase II that they decided to move directly into a Phase 3...you don't do that if people are appearing to progress shortly after receiving the vaccine."

Phase 1 and phase 2 were small samples comparatively. Some of these issues were probably not visible until they achieved a larger cohort in phase 3.

"It may simply be that they are waiting for the subgroup data to mature...that and the longer the trial is blinded the higher the probability of reaching statistical significance amongst primary and secondary end points."

If the overall group PFS data is strong enough to file for approval why wait for a subgroup analysis?

"They really need to hit their PFS target...because OS is going to be highly confounded by the addition of other treatments and the deviations from SoC..."

This I agree with. Everything is riding on their PFS target. And we have been cautioned about "havoc". Make of that what you will.