It was considered a partial hold and not for safety. The fact that they were short placebo patients and likely the regulator knew the reality was there was no placebo arm of note because of the crossover, and patients on placebo were doing worse than patients who got the drug immediately, it was in fact ethically reasonable to not have anymore placebo arm. But because of the high rate of crossover, and substantial impact on survival, I’d argue that the regulator, somewhere simply thought it was no longer ethical to have a placebo arm that was not going to be useful.
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