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Edgewise Therapeutics Clarifies FDA Warning Unrelated to Clinical Trials, Data
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Edgewise Therapeutics Clarifies FDA Warning Unrelated to Clinical Trials, Data
Dec 5, 2024 12:49 PM

03:25 PM EST, 12/05/2024 (MT Newswires) -- Edgewise Therapeutics ( EWTX ) said Thursday that the US Food and Drug Administration's warning to Han Phan at Rare Disease Research is "unrelated" to any of the company's clinical trials or data.

The warning letter issued on Nov. 27 following a site inspection was related to Phan's work with another company, according to Edgewise.

Edgewise said it has audited Phan's site multiple times and believes the data related to its clinical trials complies with the FDA's requirements.

Shares of the company were down 1.6% in recent trading.

Price: 31.56, Change: -0.50, Percent Change: -1.56

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