Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn(TM)
Friday March 3, 8:45 am ET
Company Now Has Clear Roadmap to NDS
TORONTO--(MARKET WIRE)--Mar 3, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product for the treatment of diabetes.
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The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn(TM) with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn(TM) to be marketed and distributed in Canada.
"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn(TM) and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."
The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA
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