Edgewise Therapeutics (EWTX) provided information regarding the company’s relationship with Dr. Han Phan at Rare Disease Research. “On November 27, 2024, the U.S. Food and Drug Administration issued a warning letter to Dr. Phan based on a 2024 site inspection related to her work with another company. This warning letter is unrelated to any Edgewise clinical trial or data. None of the Edgewise clinical trials are the subject of the FDA’s warning letter. Edgewise has audited Dr. Phan’s site multiple times and believes that the data related to the Edgewise clinical trials at the site are being acquired and stored in accordance with FDA requirements,” the company stated.
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