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Generex Provides Clarification of Facts
Date:6/27/2011

e on a comprehensive strategy to achieve FDA approval of Generex Oral-lyn™.  Today, Dr. Anderson, an independent member of the Generex Board, commented:  "The Company's scientific team is confident that our clinical and regulatory program is designed for success, and we intend to conduct a broader study to include a wider patient population in both type 1 and type 2 diabetes."  The full presentation from the annual meeting of stockholders' is available for viewing on the Generex website at www.generex.com.

Mark Fletcher, Generex President & Chief Executive Officer, stated:  "We have made great strides in establishing  a top notch scientific team at Generex and, as a result, have established a realistic and focused plan to realize success in the future for the largest possible patient population.  The closing of the current Phase III study and the data we obtain from it will further that effort.  Generex Oral-lyn™ has demonstrated efficacy and safety in all of the studies conducted to date."

The June 16 Generex press release stated that the Company's clinical and regulatory plan for Generex Oral-lyn™ will "focus on rapid registration in the North American major markets, with its rapid absorption and sharp peak in plasma insulin concentration mimicking normal insulin secretion, and Generex Oral-lyn™'s short duration of activity reducing the potential for hypoglycemia.  Studies will include a key activity/effect (pharmokinetic/glucodynamic) study using the final formulation and a series of small, well-designed phase 3 studies (potentially conducted as one study with multiple arms)."  Generex management anticipates that these studies will be completed during 2013.  Generex will also focus on studies that will measure Generex Oral-lyn™'s ability to provide metabolic benefits that cannot be achieved with subcutaneously inj
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SOURCE Generex Biotechnology Corporation
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