Much as we know MSCs are truly wonderful etc etc, there is no guarantee that people will not die in the treatment arm of a PCT. Nor at the time a P3 is started is there any guarantee that a new treatment is really much better than placebo/best standard of care, or proof that it might be worse. In fact the SOC may improve over time so much there is way less difference than thought by the time a longer P3 finishes.
Most variations of these have been seen during COVID-19 trials.
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-162
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