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

To: Salt'n'Peppa who wrote (8660)	2/7/2002 6:15:03 PM
From: SofaSpud	Read Replies (2) \| Respond to of 14101

Dimethaid plans rapid response to Health Canada issues on PENNSAID(R) new drug submission Company expresses extreme disappointment over tardiness of Directorate's response, 137 days beyond published deadlines TORONTO, Feb. 7 /CNW/ - Dimethaid Research Inc. (TSE: DMX) announced today that the Therapeutic Products Directorate has completed its review of the Company's New Drug Submission for PENNSAID(R) Topical Solution, after 437 days with a Notice of Non-compliance; this was 137 days after the Directorate's own self-prescribed deadline of 300 days. The Directorate has raised issues, which the Company believes should have been resolved by clarifying the information already submitted. The Company fully expects to respond in writing to all issues raised within 15 days. Assuming that the Directorate respects its own deadlines this time, it will have up to 195 days to review the Company's response. "Although we fully respect the Directorate's right to satisfy itself regarding the safety and efficacy of PENNSAID(R) before allowing its sale in Canada, it is a complete embarrassment that a product invented, developed and manufactured in Canada, after receiving approval from several European countries, has yet to be approved in Canada," said Rebecca Keeler, President and CEO. "Had the review been completed within the Directorate's own published timelines, we would have responded in early October 2001 to all the issues now being raised, enabling the review process to be completed by the end of this calendar quarter. However, due to this bureaucratic delay, Canadian patients will continue to wait for a final decision from their government in order to benefit from the option of an effective and safe alternative to pills, that PENNSAID(R) currently provides to osteoarthritis patients in the United Kingdom." With the successful completion of the U.S. Food and Drug Administration's pre-approval inspection of its Varennes, Québec plant last December, Dimethaid fully expects the review of its U.S. New Drug Application for PENNSAID(R) to be completed in a professional and timely manner. Dimethaid Research Inc. is a pharmaceutical company engaged in the development and commercialization of innovative therapeutic products that offer the potential to minimize the unwanted systemic effects of drug therapy on the body. Dimethaid's proprietary drug delivery technology utilizes the cell's tubule system to deliver drugs cell-to-cell. As a result, patients are able to treat localized conditions, such as osteoarthritis, while limiting the body's absorption of, and associated risks from, the medication. This technology has been applied first to produce PENNSAID(R) Topical Solution. The Company's business development strategy is to leverage its proprietary transdermal delivery technology into additional commercial products. For additional information on the Company, please visit www.dimethaid.com. This release may contain forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors outside management's control that could cause actual results to differ materially from those expressed in the forward-looking statements. A discussion of such risk factors is included in the Company's AIF filed with the OSC and includes, without limitation, risks regarding product development, clinical trials, dependence on third parties for development and licensing arrangements, and risks involving regulatory approval of products, licenses and patents. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect subsequent events or circumstances.