Additional Relevant Details Catalyst Pharmaceuticals provided an update on the content of the planned resubmission of the New Drug Application for Firdapse (amifampridine phosphate), which currently has Breakthrough Therapy and Orphan Drug designations for Lambert-Eaton myasthenic syndrome (LEMS). Catalyst recently met with the Food and Drug Administration to obtain greater clarity regarding what will be required by the FDA to accept the Firdapse NDA for filing.The FDA has stated that in addition to the results of the submitted multi-center, randomized, placebo-controlled, Phase 3 LMS-002 trial, the Company will need to submit positive results from an additional adequate and well-controlled study in patients with LEMS. The FDA has stated that it is open to discuss a study design that could efficiently accomplish the requirement with a small, short-term study. Additionally, there is a requirement for several more short-term toxicology studies, which are expected to start soon.