Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP) announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA(NYSE:TM)(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.
At the meeting, the FDA agreed that the proposed NDA for Northera could be submitted based on combined data from Chelsea's two completed Phase III studies in NOH, Study 301 and Study 302, without the need for any further efficacy studies. During the meeting, the agency did request and Chelsea agreed to supply top-line results from a QTc study at the time of the 90-day Safety Update and conduct a post-marketing study to evaluate the clinical pharmacology of Northera in renally impaired patients.
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases.
American Video Teleconferencing Corp. (Pink Sheets:AVOT) is pleased to announce that American Video is presently in final discussions to enter into a formal agreement to acquire an exclusive option on a molybdenum property in the Otter lake area in the province of Quebec, Canada. The property has been dormant since the 1960's when Hupon Mining and Exploration carried out surface work, stripping, trenching and a minor drill program of 445 feet contained in 11 drill holes. Some of the sample results from the trenching in 1962 showed 0.94% to 25% molybdenum averaging 5-10%. These values were obtained from assessment files in the Department of Mines in Quebec City. This property is only one of several advanced stage properties American Video has under consideration in the province of Quebec.
The two largest uses of molybdenum are as an alloy in stainless steels and in alloy steels-these two uses consume about 60% of the molybdenum needs in the United States. Stainless steels include the strength and corrosion-resistant requirements for water distribution systems, food handling equipment, chemical processing equipment, home, hospital, and laboratory requirements. Alloy steels include the stronger and tougher steels needed to make automotive parts, construction equipment, gas transmission pipes. Other major uses as an alloy include tool steels, for things like bearings, dies, machining components, cast irons, for steel mill rolls, auto parts, crusher parts, super alloys for use in furnace parts, gas turbine parts, chemical processing equipment. Molybdenum also is an important material for the chemicals and lubricant industries. Moly has uses as catalysts, paint pigments, corrosion inhibitors, smoke and flame retardants, dry lubricant (molybdenum disulfide) on space vehicles and resistant to high loads and temperatures. As a pure metal, molybdenum is used because of its high melting temperatures (4,730 F) as filament supports in light bulbs, metal-working dies and furnace parts. Major producing countries are China, Chile, and the U.S.
Rare-Earth elements are not that rare; the U.S. has plenty of the metals that are critical to many green-energy technologies, but engineering and R&D expertise have moved overseas; responding to China's near monopoly, companies in the United States and Australia are ramping up production at two rich sites for rare earths, but the process will take years.
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