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SkyLimit2022

11/18/22 12:28 AM

#534708 RE: dr_lowenstein #534696

I reviewed the message chain—Awesome point that you raised and you have presented a great opportunity to clarify the facts. It is worthwhile to review this…

Please skip to timestamp 8:01 of the recording that you published earlier today on iHub (which is linked directly below). 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.

The crossover design is also common sense if you simply think about it for a minute…

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 progression, 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://nwbio.com/wp-content/uploads/jamaoncology_liau_2022_oi_220066_1668698380.80695.pdf