NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

AVII, so how many months difference between the cohorts would you need for stat sig of .05 or less with the event size as we now have it?

We'll use your numbers.
If control does 25 months and DCVax does 28 months then, with 233 events the p value would be about 0.42.

Not even close to stat sig. Not by a mile.

To hit SS you would need 1350 events. And that would just get you 0.05 (the FDA wants better than that for single trial approvals).

So yeah, the FDA might approve it with a 3 month advantage, but they are not going to show a 3 month advantage with only 233 events.

Btw, I assume that this would compare the cohorts as at randomization of 2 to 1. What can be said about the two cohorts of 90% DCVAX and 10% without ever getting DCVAX (after unblinding)?