Saturday, July 04, 2020 8:26:40 AM
Had this actually happened the information was available. They are still blinded and know of the imbalance now, so they could have known when it happened.
Regardless, the FDA does not run the trial. They inform the sponsor/investigators what they can or can not do. The method for doing this is spelled out in law.
Furthermore, the FDA does not have any control over the sites in Germany, United Kingdom and Canada.
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