NorthWest Biotherapeutics Inc (NWBO)

[alexander77]

Also “The Company reiterated that its Phase III trial was already solidly designed prior to the enhancements just announced, with a conservative assumption that the extension of Progression Free Survival (PFS) in patients treated with DCVax-L in the Phase III trial would be only 1/3 as long as the extension of PFS (compared to PFS with standard of care) that was seen in patients treated with DCVax-L in the Phase I/II trials. This conservative assumption in the Phase III trial design was and is also combined with strong statistical powering in the trial design (with an anticipated “p value” of 0.02).”
Since p must be below .05 to be statistical significant, the company has even more safe room to be statistical significant on PFS.:
“The enhancements of the Phase III trial do not in any way seek to “rescue” a trial that is already strong and solidly designed. The changes seek to prevent external variables from potentially distorting the results of the trial, while also having the added benefit of further lowering the threshold for the primary endpoint to be met from 6 months’ difference in PFS to 4 months’ difference in PFS between patients treated with DCVax-L and the control arm. This is a further de-risking of the trial, and as such is a valuable enhancement.”

https://nwbio.com/nw-bio-corrects-ongoing-false-claims-by-feuerstein-about-phase-iii-trail-of-dcvax-l-and-interim-analysis/

“In the DCVax-L Information Arm, for the 25 GBM patients with apparent early tumor recurrence at one of two time points, 40% of the patients had reached or exceeded approximately 3 years’ survival. This substantially exceeded the expected survival time of about 15 months even for regular GBM patients without early tumor recurrence.”
https://nwbio.com/nw-bio-issues-statement-on-adverse-market-conditions-and-nw-bio-stock-decline/