Additional Relevant Details Catalyst Pharma has reached agreement with the U.S. Food and Drug Administration (FDA) on a confirmatory Phase 3 study protocol for Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). As part of the clinical protocol for the confirmatory study, Catalyst expects to initiate a small, single-center study with Firdapse during the second half of 2016. Catalyst also expects to announce additional information about the study design and timelines for the study once they are finalized.
"We are pleased to have the FDA's agreement on the design of the protocol for our second Phase 3 trial evaluating Firdapse for the treatment of LEMS. This is an important milestone in our effort to provide all LEMS patients with access to an FDA approved therapy," said Patrick J. McEnany, Catalyst's Chief Executive Officer. "Additionally, we have recently completed an analysis of our cash forecasts and budgets under our reorganized operational plan and believe, based on currently available information, that our existing capital resources are adequate to get us to an accepted NDA submission without the need for additional financing."