Replies to post #374136 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

It has nothing to do with the selection criterion being "nefarious". For a randomized trial that is perfectly proper and always will be fine tuned for the treatment.

What does not follow is that one can compare such selections to other trials that are different. Even LL said that recently when she talked about matched controls for historical comparisons. But the DE/UK docs to not say matched controls, they say contemporary trials. And this board keep comparing to non-matched controls.

Your assertion that they are on par with others is between questionable an BS, depending on the trial. And then you always have the huge elephant in the Flaskworks lab. When they pulled rPD, were they more carefull about differentiating that from psPD? Long time bull, Regina, said they were. And the methylated numbers might support her. Add that to the intent for near total resection and steroid selection and you now can explain things.

Do these in reality explain the difference? I do not claim to know. But the burden of proof is not on me.

[AVII77]

DCVax’s selection criteria is on par with all other GBM trials

No, it is not.

The DCVax trial assessed patients progression after completion of chemorad. If not progressing they could be randomized.

Most P3 GBM trials randomize earlier, before chemorad.
Avaglio, RTOG 0825, Checkmate 548, Checkmate 498, the "Dose Dense" Trial, the Centric trial. (Someone tell me again why it isnt feasible to perform a large RCT in nGBM)

Now, OPTUNE was tested in the maintenance setting, like DCVax. But, unlike the DCVax trial, they randomized patients whose GBM was only amenable to biopsy. Biopsy only patients have a far far worse prognosis.

Also, the Rindo study was tested in a maintenance setting. Like Optune (and DCVax) they screened patients for progression after chemorad. (Madingly, even though their paper says the protocol is available, they never published it as a supplemental appendix so we don't know how they did the assessment).

But for the Rindo study, all patients were EGFR+. In all other cancers, EGFR amplification is a negative prognostic factor. (There is, admittedly, some debate about what it means for GBM.)

So, tell me again how the "selection criteria is on par" with other GBM trials. It most certainly is not.