Replies to post #538061 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for posting. I recommend doing more research of this topic.

Here is Pazdur’s recent paper about external controls:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

There are many sources available about the FDA and this topic. Furthermore, it is simply common sense…

Please skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384

As NWBO moves toward the next step involving regulatory advisory, it is good to review and fact check this important point.

I suggest that you also research how the external contemporaneous controls were selected by an independent firm. Consider that the crossover was not only approved by the FDA as clinically appropriate, it was in fact required. The FDA’s job is to protect trial participants. When a trial participant with deadly GBM is presenting symptoms of advancing disease, they must be allowed to crossover. Forcing any patient to remain as a placebo subject would be insane and gruesome. Additionally, nobody would agree to it.




https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[biosectinvestor]

There was no “double dosing” and they did not “blow the comparator” with crossover. Crossover was an ethical requirement of the regulator and the patients as well. It wasn’t an option.

The fact is, you and others seem to want to make the trial a practical impossibility, as I explained early this morning. So your arguments fall apart because that is not how regulation works and definitely not in a case like this one, where patients and doctors want the treatment, the results are shown with significance and there is no safety issue and there are very few to no side-effects. You have what is clearly extension of survival, after all other treatments have ended, and in the case of recurrence and with MGMT patients. You have also what looks like, in the many instances where patients had swelling, and then the tumor disappeared, a variety of ways in which results validate the method of action. I would bet they have biomarkers that show it too, which they likely will have available for the regulator.

I just continue to see you throwing out made-up “facts” and false notions that could not possibly justify your conclusions in the end. It’s just my opinion. But you continue to have nothing but a good imagination on key details to validate your argument.

[Dr Bala]

A confounded post.

[Roman516]

The good news is that JAMA understands that DCVax-L had great results and the OS data is even more worthy based on multiple doctors, scientists and professional who are in agreement as well.