GNBT has gained 18.5% since we introduced the company to our subscribers on Monday Night 4/25. This morning Generex Biotechnology made a major milestone by becoming the first company to gain regulatory approval to market non-injectible insulin.

Generex Biotechnology...(Nasdaq: GNBT)

Press Release: Generex Biotechnology Announces First Regulatory Approval to Market Non-Injectible Insulin

Announced that Oral-lyn(TM), its proprietary oral insulin spray formulation, has been approved for commercial marketing and sale by the Ecuadorian Ministry of Public Health for the treatment of both Type-1 and Type-2 diabetes.

Since the medical miracle of the discovery of insulin by Dr. Frederick Banting and Charles Best in 1921, insulin, a life-saving drug for patients with diabetes, has been delivered solely by injection. Almost a decade of research and development at Generex has culminated in the world's first regulatory approval of an alternative method for insulin delivery, in which Oral-lyn(TM) is delivered via the Company's proprietary RapidMist(TM) device into the human mouth where it is absorbed with no lung deposition. Generex believes that Oral-lyn(TM) offers a safe, simple, convenient, fast and effective alternative to prandial insulin injections.

Generex's South American joint venture partner, PharmaBrand S.A., under the stewardship of Dr. Roberto Cid, spearheaded this regulatory effort. PharmaBrand is making preparations for the commercial launch of Oral-lyn(TM) in Ecuador this year. There are approximately 360,700 adult patients with diabetes in Ecuador (International Diabetes Federation, 2003). In addition, the Company is continuing its efforts to secure the participation of a multi-national pharmaceutical co-marketing partner for the balance of South America.

Generex believes that this approval will pave the way for additional jurisdictional approvals around the world. The Company expects to be in a position to commence Phase III clinical trials of Oral-lyn(TM) in Europe and Canada later this year.

To view the Full Press Release please visit http://biz.yahoo.com/prnews/050503/sftu107.html?.v=8

For the Full Profile on GNBT please visit http://www.smallcapreview.com/gnbt.htm

Disclaimer  

SmallCapReview.com feature stock reports are intended to be stock ideas, NOT recommendations. Please do your own research before investing. It is crucial that you at least look at current SEC filings and read the latest press releases. For continuing coverage of GNBT, please sign up for our free newsletter. Information contained in this report was extracted from current documents filed with the SEC, the company web site and other publicly available sources deemed reliable. For more information see our disclaimer section, a link of which can be found on our web site. This document contains forward-looking statements, particularly as related to the business plans of the Company, within the meaning of Section 27A of the Securities Act of 1933 and Sections 21E of the Securities Exchange Act of 1934, and are subject to the safe harbor created by these sections. Actual results may differ materially from the Company's expectations and estimates. The information provided herein is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject us to any registration requirement within such jurisdiction or country.

Copyright SmallCapReview.com. All rights reserved. SmallCapReview.com is not a Registered Broker/Dealer or Financial Advisor, nor do we hold ourselves out to be. All materials presented on our web site and individual reports released to the public through this web site, e-mail or any other means of transmission are not to be regarded as investment advice and are only for informative purposes. Before making a purchase or sale of any securities featured on our web site or mentioned in our reports, we strongly encourage and recommend consultation with a registered securities representative. This is not to be construed as a solicitation or recommendation to buy or sell securities. As with any stock, companies we select to profile involve a degree of investment risk and volatility. Particularly Small-Caps and OTC-BB stocks. All investors are cautioned that they may lose all or a portion of their investment if they decide to make a purchase in any of our profiled companies. Past performance of our profiled stocks is not indicative of future results. The accuracy or completeness of the information on our web site or within our reports is only as reliable as the sources they were obtained from. The profile and opinions expressed herein are expressed as of the date the profile is posted on site and are subject to change without notice. No investor should assume that reliance on the views, opinions or recommendations contained herein will produce profitable results. SmallCapReview.com may hold positions in securities mentioned herein, and may make purchases or sales in such securities featured on our web site or within our reports. In order to be in full compliance with the Securities Act  of 1933, Section 17(b), SmallCapReview.com will disclose in it's disclaimer, what, if any compensation was received for our efforts in researching, presenting and disseminating this information to our subscriber database and featuring the report on the SmallCapReview.com web site. SmallCapReview.com has been compensated three thousand dollars by a third party for its efforts in presenting the Generex Biotechnology profile on its web site and distributing it to its database of subscribers. SmallCapReview.com may decide to purchase or sell shares on a voluntary basis in the open market before, during or after the profiling period of this report. Information presented on our web site and within our reports contain "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact and may be "forward looking statements." Forward looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through the use of words such as ???expects??™???, ???will,??? ???anticipates,??? ???estimates, ???believes,??? or that by statements indicating certain actions ???may,??? ???could,??? or ???might??? occur.