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