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Larimar Therapeutics Announces FDA Recommendations on Safety Database, and Other Details of Nomlabofusp BLA Submission for Friedreich’s Ataxia Program
Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLAWritten FDA recommendations for safety database include a total of at least 30 participants with continuous exposure for 6 months including a subset of at least 10 with 1-year; large majority of the exposure should be on the 50 mg dose BLA submission seeking accelerated approval planned in the second quarter of 2026 to allow for inclusion of the recommended safety data for a
About this update from Larimar Therapeutics, Inc.
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