The data monitoring committee issued a statement to the FDA panels that "the remaining events to be captured during the next 18-to-24-months could have a very substantive impact on the interpretability and reliability of trial results."
Dr. Nissen argued that the study should not be stopped. It is being funded by Pfizer, but the study is being guided by an executive committee that is fully independent and unpaid, he said, adding that the data safety monitoring committee is also independent of Pfizer.
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