Replies to post #196954 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Umibe5690,

There are actually three possibilities which have been considered which all bode well. One is as Rkmatters hypothesized, if I am remembering correctly, was that the final group was the 32 pseudoprogression that were to be added into the final analysis if the primary PFS outcome measure was met or the first 38 perhaps held out separately at first due to methylation status not being known. As sentiment_stocks pointed out, there are some things that don't add up with these scenarios. The other scenario is that the last patients were all put on treatment.
This is consistent with validation of trial data from 2015. There could have been a recommendation to unblind given to NWBO ie "good news" that was unheeded because OS had not been established or because NWBO saw a positive change in efficacy being noted by new measures that needed time for validation.

Final statistical powering and OS eventing would have been adversely affected had all remaining 48 patients been kept from enrolling.
The final cohort of 31/32 patients would have all been put on treatment to finish enrolling the full preestablished number of treatment patients set to be tested by trial design while keeping the final SOC only patients from being enrolled to prevent them from being placed at greater risk of death than treatment would. These last enrolled patients may also have been part of an equivalency study that allowed for them to be kept within the Phase 3 trial parameters while being analyzed separately for outcomes. Bottom line is that any enrollment after the halt was a good sign and because the bears did such a good job of watching and reporting this enrollment we know that patients were indeed enrolled up to early November 2015, confirmed by Dr. Bosch I believe, which coupled with the enrollment curves pretty much proves that the pseudos were not added in yet nor were there 38 suddenly added in at the beginning after the screening was halted. To do this would have taken enrollment up to 300 in August of 2015 which would still not explain the 17 SOC+placebo left out when the remaining 31 were enrolled. Best wishes.