NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I respectfully disagree. The number of events to start analysis for the 1st interim review is 66. If they reviewed that group and found statistically significant efficacy would they recommend a halt? Not yet. IMHO they would then move on to the next step. They would analyze the very critical but perhaps only tertiary pseudo-progression group. If that group reached a sufficient number of events. Remember, they are like a separate trial, with their own randomization. (We learned this from a patient blog online.) Otherwise, what a waste to come that far and force another phase 3 trial on yet another pseudo-progression group (in my estimation, literally almost half of the DCVAX-L responders). No, that's not how a trial would be designed. IMHO. It would also make people all over the world with a pseudo progression response wait that much longer for commercially available DCVAX-l.

Think of it the other way around. The Pseudoprogression group finishes their minimal number of events first. No interim analysis will be initiated until the 66 events occur in the main group. Let's pretend the recommendation is a continue in the primary group after the 1st interim review, then there is no need to analyze the pseudo progression group at the first interim.

A proper design will save people from another phase III trial.

The DMC would not be violating the trial design because the separate group of (perhaps 72) pseudo progression patients are analyzed separately and not used to determine the primary endpoint. Instead they would be following the statistical rules for sequential analysis in a separate group.

However, in the end, they are necessary and very critical to come to a complete halt. The evidence must be compelling.