They seemed content to perch tranquilly on the river bank, and leave him bowed down by the weight of a great prob- lem
. He wanted it settled forthwith.
--formed a consortium to develop LEMs
. Funding for the consortium came from the Department of Transportation, the Department of Energy, the Environmental Protection Agency, and several private foundations.
FIST is a database loaded by the LEMs
for the NAVAIR APML, LEMs
, and FMS customer to track spares, support equipment, and publications for the entire aircraft as well as at the system level.
Catalyst Pharmaceuticals Inc (Nasdaq: CPRX) said on Tuesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Firdapse (amifampridine phosphate) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS
), a rare condition that affects the signals sent from the nerves to the muscles.
Specifically, Biocept's liquid biopsy tests will be offered by Catalyst Pharmaceuticals at no cost to all patients enrolled in its ongoing Phase III clinical trial designed to demonstrate the safety and efficacy of Firdapse (amifampridine phosphate) for the treatment of LEMS
Biopharmaceutical company Catalyst Pharmaceuticals (NasdaqCM:CPRX) stated on Thursday that the first patient has been admitted under its additional Phase 3 clinical trial to evaluate the efficacy and safety of Firdapse in patients with Lambert-Eaton myasthenic syndrome (LEMS
'We remain focused on delivering on our promise to transform the way people living with LEMS
and CMS are provided access to a safe and effective, FDA approved therapy.
The company added that Firdapse has received Breakthrough Therapy Designation from the US FDA for the treatment of LEMS
, as well as orphan drug designations for LEMS
and congenital myasthenic syndromes (CMS).
Last year, Catalyst reported positive top-line results from its second Phase 3 clinical trial of Firdapse for the treatment of LEMS
, which was conducted under a protocol agreed to by the FDA through the Special Protocol Assessment process.
In addition, the company stated that it had held a productive pre-NDA meeting with the FDA regarding Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS
) and, based on the discussions at that meeting, its believes its Phase 3 clinical programme will provide acceptable support for submission of an NDA for Firdapse for LEMS
The preliminary data package included the recently reported positive top-line results from a required second, confirmatory Phase 3 clinical trial of Firdapse for the symptomatic treatment of LEMS
, as well as the recently completed FDA-required abuse liability studies demonstrating that Firdapse does not have abuse potential.