Lambert-Eaton Myasthenic Syndrome (LES)

S&P 500 2,037 +15.99 +0.79% PRESS RELEASE Catalyst Pharmaceuticals Announces Encouraging Pre-NDA Meeting With the FDA for Firdapse(TM) as a Treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) By Published: Feb 2, 2015 8:03 a.m. ET SHARE   CORAL GABLES, Fla., Feb 02, 2015 (GLOBE NEWSWIRE via COMTEX) -- Catalyst Pharmaceutical Partners, Inc. CPRX, +0.00% (Catalyst Pharmaceuticals), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced it has held a productive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding Firdapse™ for the treatment of LEMS. Based on this meeting, Catalyst believes that its Phase 3 clinical program will provide acceptable support for submission of an NDA for Firdapse™ for LEMS. The Company plans to complete a full NDA submission during the 3rd quarter of 2015. Catalyst will confirm the overall regulatory path for

Catalyst starts process to offer Firdapse at no cost to  LEMS  patients in US US-based Catalyst Pharmaceutical Partners has initiated the process necessary to establish an expanded access program (EAP) to make available its investigational potassium channel inhibitor, Firdapse in the US, to patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS) through their neuromuscular disease specialists. Currently, Firdapse (amifampridine phosphate or 3,4-DAP phosphate) is in Phase III development and it will be provided at no cost until sometime following approval. Patient enrollment in the Phase III development is expected to start in the next few months, pending FDA review and approvals. Catalyst Pharmaceutical Partners CEO Patrick McEnany said, "As part of our ongoing commitment to the LEMS community, we are making Firdapse available to those who would like access to this investigational drug, but are unable to participate in clinical studies or travel to sites wher