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Re: ATLnsider post# 615211

Sunday, 07/30/2023 1:22:47 PM

Sunday, July 30, 2023 1:22:47 PM

Post# of 689131

I said I believe it was the FDA not the German regulators who placed the hold on the DCVax-L Phase III trial due to a “lack of clinical equipoise”.



I agree ATLnsider. The German Authority has nothing to do with the “hold”.
NWBio voluntarily suspended the trial ongoing in Germany ("temporary halt").

I believe it became apparent to the FDA, and all of the other regulators, that it was unethical to continue randomizing the nGBM trials patients to the SOC only arm.



I agree. Patients lived longer when treated with DCVax-L and the FDA lifted the partial hold. Changing the endpoints was the logical consequence of this decision by the FDA, IMO.
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