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Thursday, August 05, 2021 8:33:07 AM
Mr Chairman: Can you clarify your thinking during July and August 2021? You knew there was a chance that a small Massachusetts pharmaceutical company had a cure for COVID, and yet you let the trial go on for 2 months, needlessly, pointlessly, even though almost every relevant data point was already complete?
FDA Chairman: Umm. No, not in the case of an overwhelming global pandemic. We recognize that at times trial protocol must be breached due a true emergency. You would not suggest that the FDA needlessly and pointlessly let hospitals fill here and abroad, with many deaths and much suffering, if it could have been easily avoided by an early look at some trial data? In those unusual circumstances, we had to know- for sure-that IP did not have a cure already tested and ready to go.
Nr Chairman: Are you suggesting that the national and global interest is more important than a meaningless wait during the 60 long and punishing days of July and August 2021? And that protocol was put aside in the face of such worldwide suffering and death?
FDA Chairman: That is exactly what I am saying, Senator. We had to know early. We figured that the shareholders and the general public would eventually find out, in good time.
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