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Generex Provides Corporate Update
Date:8/2/2011

ical Development Plan.  At the Company's annual meeting of stockholders on June 8, 2011, Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex's Senior Scientific Advisor, provided a synopsis on the clinical and regulatory program for Generex Oral-lyn™.  The Company had received written guidance from the US Food and Drug Administration (FDA) in late May in response to data submitted on Generex Oral-lyn™.  The FDA response did not comment on any safety issues identified in the clinical trials, nor were there safety questions raised by the FDA.  The FDA did not express any concerns about the RapidMist™ delivery device.  There were a variety of questions about preclinical, clinical, toxicology, manufacturing, and regulatory and product labeling issues related to the wide variety of formulations and prior protocol changes that were made historically.  The Company is in the process of providing the additional information requested for complete clarification.  The FDA guidance placed no limitations or restrictions on the types of patients included or trial designs of current or future clinical studies.   The Company's new clinical development plan for Generex Oral-lyn™ will focus on fast-track registration in the North American major markets, highlighting the product's rapid absorption and sharp peak in plasma insulin concentration mimicking normal insulin secretion, and its 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).  It is anticipated that these studies would be completed during 2013.  A consensus meeting with the FDA to obtain agreement with the clinical plan and submission data package is planned this year to insure timely regulatory agency review
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