I agree...if the FDA continued to mess with ELTP, I agree that Elite should take their data and get approved in other countries first.
Check out "Peramivir" with its approval in Japan as Rapiacta and South Korea as Peramiflu before the FDA decides to approve it in the US as Rapivab.
DESCRIPTION
BioCryst Pharmaceuticals, Inc. (BioCryst), incorporated on November 15, 1991, is a biotechnology company. The Company designs, optimizes and develops small molecule drugs that block enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases. The Company uses X-ray crystallography, computer modeling of molecular structures and chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the enzymes that control cellular biology. The Company's drug candidates include RAPIVAB, RAPIACTA, PERAMIFLU, Avoralstat, BCX7353, other second generation hereditary angioedema (HAE) compounds, BCX4430 and Forodesine.
RAPIVAB
The Company's product RAPIVAB contains peramivir. Peramivir is an intravenous neuraminidase inhibitor approved in various countries for the treatment of patients with influenza, in the United States as RAPIVAB. Intravenous (i.v.) peramivir injection is approved in Japan as RAPIACTA and in Korea as PERAMIFLU. RAPIVAB is used for the treatment of acute uncomplicated influenza in patients of approximately 18 years and older who have been symptomatic for over two days.
Hereditary Angioedema Drug Candidates
The Company's hereditary angioedema drug candidates include Avoralstat, second generation HAE compounds and BCX7353. The Company's Avoralstat is a HAE product candidate in a suite of molecules being developed as oral treatments for the prevention of HAE attacks. Avoralstat is a selective inhibitor of plasma kallikrein in development as an orally-administered treatment for the prevention of attacks in patients with HAE. It offers second generation HAE discovery program is to discover and develop oral molecules for the prevention of HAE attacks, which have a selectivity and bioavailability profile. BCX7353 is a plasma kallikrein inhibitor. BCX7353 is a once-daily, oral prophylactic HAE treatment.
BCX4430
BCX4430 is a broad-spectrum antiviral (BSAV) research program and is being developed under a contract with the National Institute of Allergy and Infectious Diseases (NIAID/HHS). The primary focus of the program is treatment of hemorrhagic fever viruses. NIAID/HHS has supported BCX4430's development as a treatment for Marburg virus and Ebola virus. BCX4430 depicted efficacy results in animal models of infection with Marburg virus and Ebola virus. BCX4430 completely protected cynomolgus macaques from Marburg virus infection when administered by intramuscular injection over 48 hours post-infection.
Forodesine
Forodesine is a Purine Nucleoside Phosphorylase (PNP) inhibitor in development by Mundipharma as a treatment for cancer under a world-wide license agreement. PNP is a purine salvage pathway enzyme.
The Company competes with F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc, Daiichi Sankyo Co., Ltd., FUJIFIM Corporation, Tekmira Pharmaceuticals Corporation and Mapp Biopharmaceutical, Inc.
» Full Overview of BCRX.O
AI
