NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

What I know is this:

Planned interim efficacy analyses based on OS may be appropriate. However, interim efficacy analyses of PFS before completion of patient accrual are discouraged. Early interim efficacy analyses of PFS that cross a stopping boundary often overstate the magnitude of the effect. An interim PFS efficacy analysis is unlikely to provide an accurate or reproducible estimate of the treatment effect size because of inadequate follow-up, missing assessments, inconsistent readings between radiological reviewers, and/or lack of concordance between investigators and independent assessors. Stopping a trial based on interim PFS efficacy results that may not be verifiable after adjudication can render the trial results uninterpretable. In addition, a statistically significant difference in PFS that is small in magnitude may not be deemed clinically meaningful. Interim analyses to detect harmful effects or futility for PFS or OS endpoints may be appropriate.

What reason do you have for believing they would simply dismiss the above as irrelevant and go ahead with an IA efficacy analysis anyway?

Yes I believe they are well past 149 events, but if you have reviewed any post hoc case studies in clinical trials you would know that interim analyses rarely occur at presprcified triggers, and at times, and specifically because of not being fully enrolled, they are delayed.

Greater understanding and knowledge are required to comment on these matters sir. A casual, uninformed opinion after reading a few FDA docs isn't going to cut it if stating something informed and reliable is the goal.