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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: Mark Bartlett who wrote (742)	3/9/1998 11:38:00 AM
From: Mr Logic	Read Replies (2) \| Respond to of 14101

Progress. It may be taking time but at least Dimethaid is ahead of the game. Monday March 9, 11:11 am Eastern Time Company Press Release Dimethaid's PENNSAID (TM) Clears FDA Technical Screening TORONTO--(BUSINESS WIRE)--March 9, 1998--Dimethaid Research I(TSE:DMX. - news) Dimethaid Research (TSE:DMX - news) announced today that the United States Food and Drug Administration (FDA) has completed its technical screening of the New Drug Application (NDA) for PENNSAID (TM) and accepted it for full review by the Center for Drug Evaluation and Research. If approved, PENNSAID (TM) would be the first topical NSAID targeting the estimated $4 billion U.S. market for osteoarthritis. ''We are extremely pleased that PENNSAID (TM) has passed this demanding screening process, particularly given the pharmaceutical industry's historical record which shows no more than about 20 percent of drugs under development ever get to this stage,'' said Rebecca Keeler, President and CEO of Dimethaid Research. ''We will continue to respond to the FDA as it continues its assessment of the PENNSAID (TM) NDA.'' PENNSAID (TM) is a topical nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain from osteoarthritis, the most prevalent form of arthritis. An estimated 15.8 million Americans suffer from osteoarthritis according to the Arthritis Foundation. PENNSAID (TM) is the first product Dimethaid is developing using its patented carrier. A presentation on this unique transdermal delivery technology and its ability to enhance percutaneous absorption was given last week by independent researchers at the 37th Annual Meeting of The Society of Toxicology in Seattle, Washington. The expected benefits of this delivery system include localized relief at the site of application, few side effects and negligible systemic toxicity. The carrier is designed to avoid systemic distribution of its active ingredient thereby attempting to avoid the serious side effects such as gastro-intestinal bleeds and even death, that have been reported with orally administered NSAIDs. Data has been collected in Canada from over 700 physician-investigators who have prescribed PENNSAID (TM) to more than 2,400 patients in a primary care setting with the most commonly reported adverse event being minor skin irritation in fewer than 3 percent of those having used the drug. In addition to the FDA application, Dimethaid has also applied for marketing approval of PENNSAID (TM) in Canada and the United Kingdom. Dimethaid Research is a pharmaceutical company engaged in the development and commercialization of innovative therapeutic products which work with the body's own healing mechanisms.