NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Is determining IDH mutation in the current MHRA or EU clinical trial listings (taken from the submitted SAP) reflected on either of them?
No
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE


Can you show me anywhere that the SAP, or the protocol, or any article or press release or SEC filing anywhere that indicated the trial will remove the IDH-mutated patients from this trial?
No

In fact, IDH-mutation was never even mentioned in any of the leaked protocols. And the only reference to it in the JTM article was to state that it had not yet even been investigated for the trial, and that it would be unlikely to account for any survival results as it usually occurs in less than 10% of all newly diagnosed GBM patients.

And while on the subject of the JTM article, the waterfall shown there indicated that 306 patients from the total 1268 excluded from the trial, were excluded for not being GBM following a pathological diagnosis AFTER surgery.
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

306 of a total 1599 patients screened equals 19%, so I’d bet there’s not too many patients remaining in the actual DCVax-L trial who’s IDH mutation status was positive.

But now your HUGE concern is that the control arms of the other trials that might be used to comprise the EA comparators might have been stuffed with IDH mutant patients, and so those control arms would have an unfair advantage when comparing against the DCVax treatment arm… so much so that you are tempted to pull out of your investment.

As this seems to be your concern, can you given an example of a control arm in any similar matching GBM trials where there was a control arm that performed particularly well because they were stuffed with a high percentage of IDH-mutated patients?

Of course, I’m not here to argue with you about whatever decision you may want to make regarding your investment here. You’re certainly informed enough on the details of this trial and the current regulatory thinking to make that decision for yourself.

But I would point out that this entire supposition that any IDH-mutant patients found in the DCVax-L trial has primarily been promulgated by you, and perhaps picked up by others who find the argument has merit. And if you enjoy obsessing about something you think to be relevant, that’s fine. I believe that I’ve given enough reasons that support the other side of that discussion, and so for me, as it stands, I will content myself to wait and see what’s contained in the journal article itself regarding the IDH-mutation issue as that will likely provide all the answers as to how the IDH-mutation issue will be handled in this trial.