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Posted On: 09/28/2022 11:49:49 PM
Post# of 145909
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Quote:
I want to make clear, that this audit is not a question of the performance of Leronlimab in clinical trials. Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex. And We are performing this purely To assess the probability that if the BLA submission had been completed, that it would pass an FDA GCP audit.
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