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Generex Biotechnology Provides a Corporate Update to Address Management's Strategic Initiatives for Growth
Date:10/5/2010

n that same fiscal year we were permitted to charge for the product to recover costs.  Receiving that approval is an important milestone for our Company in that we are the first diabetes-related product to receive an FDA Treatment IND approval and all drugs with that type of approval have historically gone on to achieve full approval from the FDA.  We have moved forward with the implementation of this innovative program by enrolling participating health practitioners after securing requisite institutional review board approvals (see www.clinicaltrials.gov for regular updates).  I would also like to emphasize that while it is easy to look at some of the high profile pharmaceutical failures related to other non-injectable forms of insulin and just write off Generex Oral-lyn™ as more-of-the-same, the fact is that Generex Oral-lyn™, as opposed to inhaled insulin, does not and cannot go into the lungs.  In addition, Generex Oral-lyn™ does not enter (a) the gastrointestinal tract where limited absorption and removal by the liver compromises clinical efficacy, or (b) the nasal cavity where the fragile membrane limits usefulness, or (c) through the skin where extraordinary devices are required.  As the route of absorption of Generex Oral-lyn™ is through the epithelial lining of the buccal cavity, the safety and efficacy hurdles facing other forms of non-injectable insulin do not confront our product.  Results from countless studies indicate a strong desire among diabetes patients for an easy and safe alternative to insulin injections.

For the future of our buccal drug delivery platform, we intend to pursue a three-pronged approach.  First, we intend to complete our Phase III study of Generex Oral-lyn™, which currently has 460 patients enrolled, and then seek FDA and global approvals provided that the data remains consistent with previous data from this and oth
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