Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT [Yahoo! Finance]
Milestone Pharmaceuticals Inc. - Common Shares (MIST)
Last milestone pharmaceuticals inc. - common shares earnings: 3/6 07:00 am
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Source: Yahoo! Finance
MONTREAL and CHARLOTTE, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST) today announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT). 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. Based on the guidance received during the Type A Meeting, the Company expects that this approach will address the Refusal to File letter from FDA. FDA has not requested that the Company complete additional clinical efficacy or safety trials prior to r
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MIST
Earnings
- 5/13/24 - Beat
MIST
Sec Filings
- 5/13/24 - Form 8-K
- 5/13/24 - Form 10-Q
- 4/29/24 - Form 10-K/A
- MIST's page on the SEC website