NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Pyrr - In your SA article you mentioned that the sample size reestimation went from 240 to 348, but if the blinded sample size reestimation proceedure (BSSR) had calculated 360 instead, then that would have indicated that the event rate was so low that the reason almost would have to be due to superior Tx arm efficacy and not due to super low events from both control and TX arms, therefore warranting the DMC to recommend a halt of trial due to efficacy.

It seems we were so close there. Given measuring event rates overall do not require unblinding, could the DMC have another view of the overall event rate and calculate BSSR again before the first interim analysis? If an additional 3 months gets the DMC to the statistical confidence level, then we don't have to wait 6 or 12 months to the first interim.