Ardelyx provided an update regarding the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH. Earlier today, Peter Stein, Director of the Office of New Drugs, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, requested a meeting with Ardelyx to discuss the status of his review of the appeal. After a productive conversation, Stein communicated that the FDA is finalizing the response and may require up to a few more weeks to do so. Ardelyx will communicate the response to the appeal once it has been received from the FDA.
Published first on TheFly
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