$CPRX..Catalyst expects to achieve the following key milestones this year:
•Conduct Pre-NDA meeting. Catalyst expects to hold a pre-NDA meeting with the FDA in Q1 2015.
•Submit Firdapse(TM) NDA to FDA. Catalyst expects to complete its renal safety study and full toxicology program for Firdapse(TM) in Q2 2015, with an anticipated completion of an NDA submission to the FDA by Q3 2015.
•Complete launch of Firdapse(TM) expanded access program. Catalyst is currently enrolling LEMS and CMS patients in the expanded access program, which will provide Firdapse(TM) at no charge to patients who meet the inclusion/exclusion requirements.
•Complete all pre-commercialization activities required for successful Firdapse(TM) launch. The Company will continue to focus on pre-commercial activities ahead of an estimated approval / launch of Firdapse(TM) in 1H 2016.
•CPP-109: Top-line results from Tourette's Disorder. An academic investigator sponsored study evaluating CPP-109 for the treatment of Tourette's Disorder is ongoing at Mt. Sinai, in New York, and Catalysts expects to announce topline results in the first half of 2015.
•CPP-115: Catalyst expects to announce topline results from a Phase 1 multiple dose safety and tolerance study in the first half of 2015.
•Exploration of additional indications for Firdapse(TM). Catalyst plans to continue to explore additional indications including Congenital Myasthenic Syndrome and refractory Myasthenia Gravis.
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