Cartesian Therapeutics (RNAC) announced that it has received written agreement from the U.S. Food and Drug Administration, FDA, under the Special Protocol Assessment, SPA, process on the overall design of the Company’s planned Phase 3 AURORA trial for Descartes-08, its lead mRNA cell therapy candidate, in myasthenia gravis, MG. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial.
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