Replies to post #672749 on NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

I think it is Hail Mary they are trying with MHRA. Even if by some lucky chance MHRA approves,there is no doubt that the EMA and FDA reject this without question. Changing the endpoints knowing that primary failed kills the integrity of the trial. This is a shortcut to save money.

[Doc logic]

exwannabe,

1). There is no spinning when treatment effect in crossover patients is real and easy to recognize because nothing else given causes this OS increase in rGBM patients.
2). To this day there is still no absolute way to distinguish treatment induced pseudoprogression from actual progression in all patients with radiological visual examination readouts.
3). Noted treatment benefit from crossover benefit has reason to be studied and discussed not just discounted and thrown out like you attempt to do. JAMA Oncology published the article and its conclusions based on the rigor and independence of the ECA comparators utilized in the comparison of ndGBM and rGBM patients treated with DCVax-L thus affirming the conclusions made. [You and no one on this board is in any position of authority to refute JAMA’s affirmation of this data and methods used to determine treatment effect when they published this study. All you can do is cast opinion and doubt from the grandstands while you root for another team.]
4). Switching endpoints in blinded fashion is completely legit. Inferring that NWBO was unblinded to results before the switch to OS was made is blatant misinformation and infers NWBO is a scam company trying to extend the process not for the sake of patients but only for their own financial benefit. If NWBO had been unblinded or did not have a legitimate reason to make the switch to OS, such as treatment induced pseudoprogression, then JAMA Oncology would not have peer reviewed the results because their reputation is on the line. The SAP would not have been accepted by all the regulators either which was the first clue that the data and measures used to test for treatment effect were and are sufficient for such a determination.
One last point being that Advent is not being built up on support from a scam company as claimed by you and the rest of the team but on support for the effort from the likes of Dr. Keyoumars Ashkan who has stated that he wants DCVax-L for all of his patients.
5). Patient matching was not possible for this trial, however, these ECAs were independently composed by a very capable panel and every effort was made to produce a fair comparison. This was validated by regulator acceptance of the ECAs by way of acceptance of the SAP and further validation by MHRA acceptance of the PIP which is for a future pediatric trial based on these same type of ECAs and JAMA Oncology peer review. Your inferences that these ECAs are biased or unacceptable are completely unfounded fabrications that the experts have overruled you on and soon will use as the basis for approval of DCVax-L for GBM, rGBM and likely lower grade gliomas. Best wishes.