Faraday Pharmaceuticals Announces Agreement with FDA on Interim Analysis of Phase 3 IOCYTE AMI-3 Trial Data and EU Notice of Intention to Grant Patent
The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.
- The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.
- The SPA amendment optimizes the timing, based on the study’s current enrollment rate, and expands the data set of the interim analysis.
- The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration.
- For more information on the IOCYTE AMI-3 Phase 3 please visit ClinicalTrials.gov and reference Identifier NCT04837001 .