NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Quote:

His "tripping factor" comment is saying IF the entire trial is marginal, and the mesenchymal subset is strong, they might approve the subset. I have seen a case of this (forget who), so have to agree with him there. But it would not be normal for the FDA to do this. - exwannabe-

You are correct but FDA needs something that works for GBM and the OS appears to be greater than 24 months here as per Dr. Linda Liau's comments in her October presentation. Her OS referrence points for survival were from newer data indicating 24 months OS possible. Accordingly, this DCVax-L protocol is benefitting patients with OS beyond this mark as per her comment about all patients apparently living longer. Besides the stronger mesenchymal results, Dr. Liau mentioned how even some proneural patients can benefit at crossover by using the right kind of chemo. I am sure doctors at all clinical trial sites were made aware of her findings.


The questions surrounding the length of time taken so far with the screening suspension and the investigation has created shaky ground for investors due to time=money losses. Linda did say she intended for the trial to go to the end, perhaps in anticipation of needing to have more mature OS data. Regulators appear to be dealing with a good deal of information, some of which may be being reviewed in an ongoing process. I would think that a co-primary OS petition would not take this long but other reviews could take up to about 9 months. Multiple reasons for this delay seem to be reasonable. Though accounted for otherwise in disclaimers, there is every reason to believe this trial will finish enrollment and then finish on or near on schedule. Safety does not seem to be a cause of concern so finishing should not be an issue. This as a minimum brings HE revenue.