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Milestone Pharmaceuticals Plans To Resubmit The NDA For Etripamil To FDA For Paroxysmal Supraventricular Tachycardia

Author: Benzinga Newsdesk | February 26, 2024 08:04am

Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with FDA. FDA indicated that the timing of adverse events (AEs) in question had minimal impact on the overall characterization of the etripamil safety profile. To align with FDA's guidance, the Company will restructure the data sets that capture timing of reported AEs, reformat certain data files to facilitate FDA's analyses, and resubmit the NDA. 

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