Wall Street fecha semana sem rumo. Grandes tecnológicas pressionam

[pedro200]

http://pipelinereview.blogspot.com/

Em Wednesday, June 8, 2011:

"Dr von Hofe began his presentation by mentioning the approval of Dendreon's Provenge as ushering in the new era of immunotherapeutics. Antigen Express is developing the next generation of immunotherapeutic peptide vaccines, which have the advantage of being off the shelf, self potentiating, and are fully synthetic. The focus is on unmet medical needs, and Antigen has a promising technology platform. Dr von Hofe continued to explain the importance of activating CD4+ T helper cells, as I explained in my latest blog"

"The most exciting update from Dr von Hofe had to due with a prospective partnership for AE37 in HER2/new expressing breast cancer patients. Dr von Hofe stated that the company should be in position to announce a partner later this year. He also informed that a large scale SPA Phase III for AE37 for breast cancer patients is being prepared to commence in the first quarter of 2012. The study population in the Phase III study will include 1000 node positive or high risk node negative HER2 expressing patients, with FISH scores as low as HER2 1, which are not eligible for Roche's Herceptin. A large scale study of this size can cost upwards of $100 million, so the company must be confident that they will secure a partner to help with the costs. Interim data from the ongoing Phase II study for breast cancer patients will be presented in the third quarter of this year, as well as in December at the San Antonio Breast Cancer Symposium"

[pedro200]

2012 Preview: Cancer Immunotherapy Catalysts

2012 Preview: Cancer Immunotherapy Catalysts
http://seekingalpha.com/article/314109- ... l_porfolio

[francisco lopes]

desculpa esteve a 0.32 a partir das 23 horas ate perto
da 1.30 mas ate e natural pois este titulo tem grandes oscilaçoes e alguem pode ter comprado meia duzia de açoes pra tentar impulsinar o titulo
abraço

[francisco lopes]

SHEVET agora realmente esta 0.12 mas na hora que postei
estava a 0.32 e esteve bastante tempo assim
perto da meia noite e meia voltou a 0.12

abraço

[Shevet]

CAROS amigos se algum de vos tivesse visto o
MARKET WACHT naquela hora no after market iria ver que estava a 0.32

Caro francisco, era uma boa prenda de Natal!!
Estas a falar do bigchartsmarketwatch certo?? se la fores agora, deveria aparecer o fecho em after market e não aparece nada!!

Já agora viste o volume que fez, quando viste essa cotação???

[francisco lopes]

CAROS amigos se algum de vos tivesse visto o
MARKET WACHT naquela hora no after market iria ver que estava a 0.32

[Shevet]

Esta menina esta a subir so 173 % no after hours

IN YOUR DREAMS????!!!!!

Não encontro isso em lado nenhum!!!

[pedro200]

Esta menina esta a subir so 173 % no after hours

[ruisebas]

Onde consegues ver essa informação, no google finance não aparecem esses valores...

[francisco lopes]

Esta menina esta a subir so 173 % no after hours

[pedro200]

http://lifesciencedigest.com/2011/12/14 ... catalysts/

[andraderui]

http://finance.yahoo.com/q/mh?s=GNBT.OB+Major+Holders

[fcpfcp]

Alguem me consegue dizer quais os principais acionistas e a sua percentagem aproximada do capital detido por cada um deles ?

[Nyk]

Vamos ver se é desta que ela nos surpreende

[pedro200]

Newsweek Magazine:

12 de Dezembro de 2011

Could This Be The End Of Cancer?

http://www.thedailybeast.com/newsweek/2 ... ancer.html

[pedro200]

Breast Cancer Vaccine Being Developed by Generex Subsidiary Antigen Express to be Featured on Bloomberg Television

http://finance.yahoo.com/news/Breast-Ca ... 6.html?x=0

[Nyk]

Form 10-Q for GENEREX BIOTECHNOLOGY CORP

Quarterly Report



12-Dec-2011

Quarterly Report



Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
As used herein, the terms the "Company," "Generex," "we," "us," or "our" refer to Generex Biotechnology Corporation, a Delaware corporation. The following discussion and analysis by management provides information with respect to our financial condition and results of operations for the three-month periods ended October 31, 2011 and 2010. This discussion should be read in conjunction with the information contained in Part I, Item 1A - Risk Factors and Part II, Item 8
- Financial Statements and Supplementary Data in our Annual Report on Form 10-K for the year ended July 31, 2011, as amended, and the information contained in

Part I, Item 1 - Financial Statements and Part II, Item 1A- Risk Factors in this
Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2011.
Forward-Looking Statements

We have made statements in this Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology Corporation for the fiscal quarter ended October 31, 2011 that may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in any lawsuit based on forward-looking statements that we have made. All statements, other than statements of historical facts, included in this Quarterly Report that address activities, events or developments that we expect or anticipate will or may occur in the future, including such matters as our projections, future capital expenditures, business strategy, competitive strengths, goals, expansion, market and industry developments and the growth of our businesses and operations, are forward-looking statements. These statements can be identified by introductory words such as "may," "expects," "anticipates," "plans," "intends," "believes," "will," "estimates" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Our forward-looking statements address, among other things:

� our expectations concerning product candidates for our technologies;

� our expectations concerning existing or potential development and license agreements for third-party collaborations, acquisitions and joint ventures;

� our expectations of when different phases of clinical activity may commence and conclude;

� our expectations of when regulatory submissions may be filed or when regulatory approvals may be received; and

� our expectations of when commercial sales of our products may commence and when actual revenue from the product sales may be received.

Any or all of our forward-looking statements may turn out to be wrong. They may be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties. Actual outcomes and results may differ materially from what is expressed or implied in our forward-looking statements. Among the factors that could affect future results are:

� the inherent uncertainties of product development based on our new and as yet not fully proven technologies;

� the risks and uncertainties regarding the actual effect on humans of seemingly safe and efficacious formulations and treatments when tested clinically;

� the inherent uncertainties associated with clinical trials of product candidates;

� the inherent uncertainties associated with the process of obtaining regulatory approval to market product candidates;

� the inherent uncertainties associated with commercialization of products that have received regulatory approval;

� the volatility of, and decline in, our stock price; and

� our ability to obtain the necessary financing to fund our operations and effect our strategic development plan.

Additional factors that could affect future results are set forth in Part I, Item 1A Risk Factors of our Annual Report on Form 10-K for the year ended July 31, 2011, as amended, and in Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. We caution investors that the forward-looking statements contained in this Quarterly Report must be interpreted and understood in light of conditions and circumstances that exist as of the date of this Quarterly Report. We expressly disclaim any obligation or undertaking to update or revise forward-looking statements to reflect any changes in management's expectations resulting from future events or changes in the conditions or circumstances upon which such expectations are based.



--------------------------------------------------------------------------------

Executive Summary

Overview of Business

We are engaged primarily in the research and development of drug delivery systems and technologies. Our primary focus at the present time is our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Through our wholly-owned subsidiary, Antigen, we have expanded our focus to include immunomedicines incorporating proprietary vaccine formulations.

We believe that our buccal delivery technology is a platform technology that has application to many large molecule drugs and provides a convenient, non-invasive, accurate and cost-effective way to administer such drugs. We have identified several large molecule drugs as possible candidates for development, including estrogen, heparin, monoclonal antibodies, human growth hormone and fertility hormone, but to date have focused our development efforts primarily on one pharmaceutical product, Generex Oral-lyn�, an insulin formulation administered as a fine spray into the oral cavity using our proprietary hand-held aerosol spray applicator known as RapidMist�.

Our wholly-owned subsidiary, Antigen, concentrates on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e. self proteins and allergens). Our immunomedicine products are based on two platform technologies and are in the early stages of development. We continue clinical development of Antigen's synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I clinical trials. We recently initiated an additional Phase I clinical trial in patients with either breast or ovarian cancer. The synthetic vaccine technology has certain advantages for pandemic or potentially pandemic viruses, such as the H5N1 avian and H1N1 swine flu. In addition to developing vaccines for pandemic influenza viruses, we have vaccine development efforts underway for seasonal influenza virus, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus. We have established collaborations with clinical investigators at academic centers to advance these technologies.

Financial Condition

As of October 31, 2011, our current cash position is not sufficient to meet our working capital needs for the next twelve months based on the pace of our planned activities. To continue operations, we will require additional funds to support our working capital requirements and any expansion or other activities, or will need to significantly reduce our clinical trials and other planned activities or suspend operations. Management is seeking various alternatives to ensure that we can meet some of our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities. In addition, management is actively seeking strategic alternatives, including strategic investments and divestitures. Management has sold, and is also seeking further sales of, non-essential real estate assets which are classified as Assets Held for Investment to augment its cash position. We cannot provide any assurance that we will obtain the required funding. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and our strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected and we may have to cease operations.

Generex Oral-lyn�

Regulatory Approvals and Clinical Trials

To date, we have received regulatory approval in Ecuador, India (subject to further study), Lebanon and Algeria for the commercial marketing and sale of Generex Oral-lyn�. We have submitted regulatory dossiers for Generex Oral-lyn� in a number of other countries, including Syria, Bangladesh, Kenya, Yemen, Iran, Sudan, Jordan and Armenia. While we believe these countries will ultimately approve our product for commercial sale, we do not anticipate recognizing revenues in any of these jurisdictions in the next twelve months.

In March 2008, we initiated Phase III clinical trials for this product in the U.S. with the first patient screening for such trials at a clinical study site in Texas in April 2008. Approximately 450 patients have been enrolled to date at approximately 70 clinical sites around the world, including sites in the United States, Canada, Bulgaria, Poland, Romania, Russia, Ukraine and Ecuador. The final subjects completed the trial in August 2011, and we hope to provide preliminary results from the trial to the U.S. Food and Drug Administration (the "FDA") by the end of the 2011 calendar year.

Special Access Programs

In October 2009, we received approval from the FDA to charge to recover costs for the treatment use of Generex Oral-lyn� in patients with Type 1 or Type 2 diabetes mellitus in the FDA's Treatment Investigational New Drug ("IND") program that provides for early access to investigational treatments for life-threatening or otherwise serious conditions. This approval allows diabetes patients who do not otherwise qualify to participate in a clinical trial or who have no other satisfactory alternative treatment for diabetes to have access to Generex Oral-lyn�. In April 2008, we received a Special Access Program ("SAP") authorization from Health Canada for a patient-specific, physician-supervised treatment of Type-1 diabetes with Generex Oral-lyn�. SAP provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are not available or are unsuitable. We received a similar authorization from health authorities in Netherlands in July 2008.

Marketing

We have entered into licensing and distribution agreements with a number of multinational distributors to assist us with the process of gaining regulatory approval for the registration, marketing, distribution, and sale of Generex Oral-lyn� in countries throughout the world, including:

� Shreya Life Sciences Pvt. Ltd. for India, Pakistan, Bangladesh, Nepal, Bhutan, Sri Lanka, and Myanmar;

� Adcock Ingram Limited and Adcock Ingram Healthcare (Pty) Ltd. for South Africa, Lesotho, Swaziland, Botswana; Namibia, Mozambique and Zimbabwe;

� E&V Alca Distribution Corp. for Albania, Montenegro, and Kosovo;

� Medrey S.A.L. (formerly MedGen Corp.) and Benta S.A.L. for Lebanon;



--------------------------------------------------------------------------------

� SciGen, Ltd. for China, Hong Kong, Indonesia, Malaysia, the Philippines, Singapore, Thailand and Vietnam;

� Pharmaris Perus S.A.C. for Peru;

� MediPharma SA for Argentina;

� PMG S.A. for Chile; and

� Dong Sung Pharm. Co. Ltd. for South Korea.

Under these licensing and distribution agreements excluding the one with Dong Sung Pharm Co., we will not receive an upfront license fee, but the distributor will bear any and all costs associated with the procurement of governmental approvals for the sale of Generex Oral-Lyn�, including any clinical and regulatory costs. We possess the worldwide marketing rights to our oral insulin product.

In August 2008, we entered into a product licensing and distribution agreement with Dong Sung Pharm Co. Ltd. for the importation, marketing, distribution and sale of Generex Oral-lyn� in South Korea. Under the seven-year agreement, Dong-Sung will have an exclusive license. Per the terms of the agreement, Dong-Sung paid us a USD $500,000 non-refundable license fee upon execution and will pay us a USD $500,000 non-refundable license fee at such time as governmental approval for the importation, marketing, distribution and sale of the product in South Korea is obtained. Under this agreement, we are responsible for procuring such governmental approval. In addition, when it places its first purchase order, Dong-Sung will pay us a pre-payment in the amount of USD $500,000, which will be applied against product purchase orders.

In December 2008, we, together with our marketing partner Benta SA., received an approval to market Generex Oral-lyn� in Lebanon. Benta is currently working on reimbursement policy for Generex Oral-lyn�. The official product launch in Lebanon took place in May 2009.

In India, a marketing plan has already been submitted by Shreya Life Sciences Pvt. Ltd., to Generex on the marketing strategy for the distribution of Oral Recosulin�-the trademark under which Shreya will market Generex Oral-lyn� within India. The marketing plan also includes post-approval marketing studies. Per the requirements of the regulatory approval in India, an in-country clinical study must be completed in India with Oral Recosulin� before commercial sales can commence. We have not recognized any revenues from the sale of Generex Oral-lyn� in India through the end of the 2011 fiscal year or in the first quarter of the 2012 fiscal year.

Cancer and Immunotherapeutic Vaccine Platforms

Our wholly-owned subsidiary, Antigen, is developing proprietary vaccine formulations based upon two platform technologies that were discovered by its founder, the Ii-Key hybrid peptides and Ii-Suppression. These technologies are applicable for either antigen-specific immune stimulation or suppression, depending upon the dosing and formulation of its products. Using active stimulation, we are focusing on major diseases such as breast, prostate and ovarian cancer, melanoma, influenza (including H5N1 avian and H1N1 swine flu) and HIV. Autoimmune disease such as diabetes and multiple sclerosis are the focus of our antigen-specific immune suppression work.

Antigen's immunotherapeutic vaccine AE37 is currently in Phase II clinical trials for patients with HER-2/neu positive breast cancer. The trial is being conducted with the United States Military Cancer Institute's (USMCI) Clinical Trials Group and will examine the rate of relapse in patients with node-positive or high-risk node-negative breast cancer after two years. The study is randomized and will compare patients treated with AE37 plus the adjuvant GM-CSF versus GM-CSF alone. The Phase II trial follows a Phase I trial that demonstrated safety, tolerability, and immune stimulation of the AE37 vaccine in breast cancer patients.

Based on positive results in trials of the AE37 vaccine in breast cancer patients, we entered into an agreement in August 2006 with the Euroclinic, a private center in Athens, Greece, to commence clinical trials with the same compound as an immunotherapeutic vaccine for prostate cancer. A Phase I trial involving 29 patients was completed in August 2009, which similarly showed safety, tolerability and induction of a specific immune response. Agreements are in place for initiation of a Phase II clinical trial.

The same technology used to enhance immunogenicity is being applied in the development of a synthetic peptide vaccine for H5N1 avian influenza and the 2009 H1N1 swine flu. In April 2007, a Phase I clinical trial of Antigen's proprietary peptides derived from the hemagglutinin protein of the H5N1 avian influenza virus was initiated in healthy volunteers in the Lebanese-Canadian Hospital in Beirut, Lebanon. We have completed the first portion of the Phase I trial. Modified peptide vaccines for avian influenza offer several advantages over traditional egg-based or cell-culture based vaccines. Modified peptide vaccines can be manufactured by an entirely synthetic process which reduces cost and increases both the speed and quantity of vaccine relative to egg- or cell-culture based vaccines. Another advantage is that the peptides are derived from regions of the virus that are similar enough in all H5N1 and H1N1 virus strains such that they would not have to be newly designed for the specific strain to emerge in a pandemic.

In March 2007, Antigen entered into an agreement with Beijing Daopei Hospital in Beijing, China to conduct clinical trials using Antigen's pioneering technology for suppressing Ii expression using RNA interference (RNAi) to stimulate an immune response to patients' cancer cells. The strategy developed by Antigen for modifying the patient's cancer cells increases their immunogenicity and thereby enables the immune system to fight off the cancer cells anywhere in the patient's body. Antigen has developed proprietary methods using RNAi to specifically inhibit expression of the Ii protein in cancer cells already expressing MHC class II molecules that are amenable to clinical use. Cancer cells from patients with acute myelogenous leukemia will be transfected with a vector expressing RNAi to silence Ii expression. After lethal irradiation, the cells are re-introduced as a subcutaneous immunization to the patient.
Preliminary work under the agreement has commenced. Due to regulatory changes in China's approval process relating to these types of studies, it is unclear when the trial might commence.



--------------------------------------------------------------------------------

A Physician's Investigational New Drug ("IND") application for the Phase I and Phase II trials in patients with stage II HER-2/neu positive breast cancer has been filed with the FDA. The Phase I trial was completed at the Walter Reed Army Medical Center in Washington, D.C., and the Phase II trial is taking place at 13 sites, including 11 in the U.S., one in Germany and one in Greece. A Physician's Investigational New Drug application for a Phase I trial in patients with breast or ovarian cancer also has been filed with the FDA and this Phase I trial is being conducted in Dallas, Texas at the Mary Crowley Cancer Center. Applications were filed and approvals obtained for a Phase I prostate cancer trial using AE37 in Athens, Greece from the Hellenic Organization of Drugs, and this Phase I trial was completed in August 2009. The Ministry of Health in Lebanon gave approval for Phase I trial of our experimental H5N1 prophylactic vaccine in Beirut, Lebanon following submission of an application. All other immunomedicine products are in the pre-clinical stage of development.

Other Potential Buccal Products

We have had discussions regarding possible research collaborations with various pharmaceutical companies concerning use of our large molecule drug delivery technology with other compounds, including monoclonal antibodies, human growth hormone, fertility hormone, estrogen and heparin, and a number of vaccines. We are currently pursuing development opportunities to complement our insulin therapy. Amarantus BioSciences and Generex Biotechnology announced in June 2011 that they are working towards establishing a collaboration on cell therapy for late stage diabetes, but as of the date of this report, no definitive agreements have been signed.

In October 2008, we announced the enrollment of subjects in our bioequivalence clinical trial of MetControl�, our proprietary Metformin medicinal chewing gum product, conducted in the United States. The protocol for the study is an open-label, two-treatment, two-period, randomized, crossover study comparing MetControl� and immediate release Metformin� tablets in healthy volunteers. The study results that we received and analyzed in December 2008 demonstrated bioequivalence. We are evaluating the economics of proceeding with this product with a suitable partner. We have not expended resources to further develop this product during the 2011 fiscal year or the three months ended October 31, 2011.

Consumer/Over-the-Counter Glucose Product Line

Using our buccal delivery technology, we have launched an over-the-counter glucose spray, Glucose RapidSpray�. In addition, we have entered into a marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of, Glucose RapidSpray� brand formulated glucose spray product.
Merck will market and distribute the product in Mexico as Diabion� GlucoShot�. To date, we have received modest revenues from sales of these products which are available in retail stores and independent pharmacies in the United States and Canada. We do not plan to focus significant resources on these products going forward, other than any resources which may be required to support the Merck agreement.

Competition

We face competition from other providers of alternate forms of insulin. Some of our most significant competitors, Pfizer, Eli Lilly, and Novo Nordisk, have announced that they will discontinue development and/or sale of their inhalable forms of insulin. Generex Oral-lyn� is not an inhaled insulin; rather, it is a buccally absorbed formulation with no residual pulmonary deposition. We believe that our buccal delivery technology offers several advantages, including the ease of use, portability, avoidance of pulmonary inhalation and safety profile. Furthermore, insulin administered through the Generex Oral-lyn� RapidMist� technology is absorbed directly into the blood stream and not only acts rapidly, but returns to baseline quickly, thereby minimizing the chance of developing hypoglycemia.

In May 2009, Mannkind Corporation submitted an NDA to the FDA requesting approval to market AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder, for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia, and the NDA is still currently under review by the FDA. In addition to other delivery systems for insulin, there are numerous products, such as sulfonylureas (Amaryl�and Glynase�), biguanides (branded and generic metformin products), thiazolidinediones (Avandia�and Actos�), glucagon-like peptide 1 (Byetta�and Victoza�), and dipeptidyl peptidase IV inhibitors (Januvia� and Onglyza�), which have been approved for use in the treatment of Type 2 diabetics in substitution of, or in addition to, insulin therapy. These products may also be considered competitive with insulin products.

Large pharmaceutical companies, such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc., MedImmune Inc. (a subsidiary of Astra-Zeneca, Inc.) and others, also compete against us in the oncology, immunomedicine and vaccine markets. These companies have competing experience and expertise in securing government contracts and grants to support research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, as well as manufacturing and marketing approved products. As such, they are also considered significant competitors in these fields of pharmaceutical products and therapies. There are also many smaller companies which are pursuing similar technologies in these fields who are considered to be competitors of Generex.



--------------------------------------------------------------------------------

Brief Company Background

We are a development stage company. From inception through the end of the quarter ended October 31, 2011, we have received only limited revenues from operations. In the quarter ended October 31, 2011 and in the fiscal year ended July 31, 2011, we generated $9,931 and $291,628 in revenue, respectively. The revenue in each of the fiscal periods pertained primarily to the sale of our consumer/over-the-counter products. These numbers do not reflect deferred sales to customers during the respective periods with the right of return.

We operate in only one segment: the research and development of drug delivery systems and technologies for metabolic and immunological diseases.

We were incorporated in the State of Delaware in 1997. Our principal executive offices are located at 33 Harbour Square, Suite 202, Toronto, Canada, and our telephone number at that address is (416) 364-2551. We maintain an Internet website at www.generex.com. We make available free of charge on or through our website our filings with the SEC.

Accounting for Research and Development Projects

Our major research and development projects are the refinement of our platform buccal delivery technology, our buccal insulin project (Generex Oral-lyn�), our buccal morphine product and Antigen's peptide immunotherapeutic vaccines.

During the first quarter of the current fiscal year and during the last fiscal year, we expended resources on the clinical testing of our buccal insulin product, Generex Oral-lyn�. In July 2007, we received no objection from the FDA to proceed with our long-term multi-center Phase III study protocol for Generex Oral-lyn�, which study is ongoing. Late-stage trials involve testing our product with a large number of patients over a significant period of time. The completion of late-stage trials in Canada and eventually the United States may require significantly greater funds than we currently have on hand.

While Generex Oral-lyn� has received regulatory approval in Ecuador, India (subject to the completion of an in-country study), Lebanon and Algeria, we have not recognized any revenue from sales of Generex Oral-lyn� in Ecuador, India or Algeria to date and only modest revenues in Lebanon. We do not expect that the near-term revenues from the sales of Generex Oral-lyn� in the countries where we currently have regulatory approval will be sufficient to sustain our research and development and regulatory activities.

Although we have initiated the regulatory approval process for our morphine and fentanyl buccal products, we did not expend resources to further this product during our last fiscal year or during the first quarter of this fiscal year.

During the first quarter of the current fiscal year and during the last fiscal year, we expended resources on research and development relating to Antigen's peptide immunotherapeutic vaccines and related technologies. Antigen has one vaccine currently in Phase II clinical trials in the United States involving patients with HER-2/neu positive breast cancer and has completed a Phase I clinical trial for a vaccine for H5N1 avian influenza at the Lebanese-Canadian Hospital in Beirut. Antigen's prostate cancer vaccine based on AE37 has been tested in a completed (August 2009) Phase I clinical trial in Greece. Preliminary pre-clinical work has commenced with respect to the experimental vaccine for patients with acute myeloid leukemia at Beijing Daopei Hospital in China.

Because of various uncertainties, we cannot predict the timing of completion and commercialization of our buccal insulin in all jurisdictions or Antigen's peptide immunotherapeutic vaccines or related technologies. These uncertainties include the success of current studies, our ability to obtain the required financing and the time required to obtain regulatory approval even if our research and development efforts are completed and successful, our ability to enter into collaborative marketing and distribution agreements with third-parties, and the success of such marketing and distribution arrangements. For the same reasons, we cannot predict when any products may begin to produce net cash inflows.

Most of our buccal delivery research and development activities to date have involved developing our platform technology for use with insulin. Insubstantial . . .

http://biz.yahoo.com/e/111212/gnbt.ob10-q.html

[Nyk]

Generex Biotech and Avanir Pharmaceuticals Look to Rally in 2012
The Paragon Report Provides Equity Research on Generex Biotechnology & Avanir Pharmaceuticals

NEW YORK, NY--(Marketwire -12/12/11)- The biotechnology industry has been a strong performer in 2011 as mergers and acquisitions and favorable legislation have propped up the sector. The domestic biotechnology industry has tapped into only a fraction of its several potential applications and is expected to grow to $146.2 billion in 2016, from an estimated $92.4 billion in 2011, according to a report from IBISWorld. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Generex Biotechnology Corporation (OTC.BB: GNBT.OB - News) and Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR - News). Access to the full company reports can be found at:

www.paragonreport.com/GNBT

www.paragonreport.com/AVNR

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. Last month the company announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application for NUEDEXTA for the treatment of pseudobulbar affect (PBA).

NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.

Generex Biotechnology Corporation is a development stage company engaged in the research and development of drug delivery systems and technologies for metabolic and immunological diseases. Last week shares of the company spiked after it announced that positive interim Phase 2 clinical data from its ongoing study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients were presented at the 34th Annual CTRC-AACR.

Generex explains that its Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer

http://finance.yahoo.com/news/Generex-B ... 6.html?x=0

[pedro200]

Boa tarde,
Para ler o texto colocado hoje utilizei o tradutor devido ao meu mau inglês. Parece que as noticias não são más? Contudo a cotação não tem parado de cair! Será que alguém entendido pode fazer o favor de acrescentar algo mais?
Comprei a 0.30, e só espero um golpe de sorte.

carissimo,
a GNBT é uma biotecnológica. Já apresentou medicamentos muito promissores nomeadamente no combate ao cancro ( quem não tem o azar de saber o que é o Herceptin... está com muita sorte!) e medicamentos para a Diabetes que é o caso deste Oral Lin (?).
Ou seja era possível que um sucesso de um destes medicamentos fizesse disparar a cotação...

tal não aconteceu.

eu tive GNBT e saí quase sem perdas.

olhe quer um conselho... eu acho que o que lhe falta perder deve ser pouco...

Ver:
Prof. Peoples (foi ele que estve ontem na http://www.sabcs.org/ faz parte da equipa da generex)


http://www.youtube.com/watch?v=-BUvWOdK ... re=related

[pvg80713]

martins,

pense que tem a imensa sorte de só conhecer a GNBT da bolsa.

se tivesse o azar de a conhecer de outro sítio... ia certamente perder muito mais !

haja saúde !

celebre a sua perda !

[amartins42]

Agradeço ao pvg80713 a ajuda que me deu no seu comentario. Contudo, hoje, está a levantar, já chegou aos 0,11...

[pvg80713]

Boa tarde,
Para ler o texto colocado hoje utilizei o tradutor devido ao meu mau inglês. Parece que as noticias não são más? Contudo a cotação não tem parado de cair! Será que alguém entendido pode fazer o favor de acrescentar algo mais?
Comprei a 0.30, e só espero um golpe de sorte.

carissimo,
a GNBT é uma biotecnológica. Já apresentou medicamentos muito promissores nomeadamente no combate ao cancro ( quem não tem o azar de saber o que é o Herceptin... está com muita sorte!) e medicamentos para a Diabetes que é o caso deste Oral Lin (?).
Ou seja era possível que um sucesso de um destes medicamentos fizesse disparar a cotação...

tal não aconteceu.

eu tive GNBT e saí quase sem perdas.

olhe quer um conselho... eu acho que o que lhe falta perder deve ser pouco...

[amartins42]

Boa tarde,
Para ler o texto colocado hoje utilizei o tradutor devido ao meu mau inglês. Parece que as noticias não são más? Contudo a cotação não tem parado de cair! Será que alguém entendido pode fazer o favor de acrescentar algo mais?
Comprei a 0.30, e só espero um golpe de sorte.

[Nyk]

Leading Investigator to Present Clinical Data on Generex Oral-lyn™ at International Diabetes Federation Meetings in Dubai

Clinical Data Provides Further Evidence of Effectiveness in Treatment of Prediabetes




WORCESTER, Mass. and TORONTO , Dec. 7, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT.OB - News) announced today that a group of physicians led by Professor Paolo Pozzilli at the University Campus Bio-Medico in Rome, Italy , will provide an update on results of using Generex Oral-lyn™ as it pertains to prediabetes at the forthcoming International Diabetes Federation (IDF) Congress, to be held in Dubai , December 3 rd-8th, 2011.

(Logo: http://photos.prnewswire.com/prnh/20110 ... 5057LOGO-b)

The paper is entitled "Buccal Spray Insulin for The Treatment of Impaired Glucose Tolerance" and is presented by Dr. Y.M. Khazrai of Dr. Pozzilli's research team.

The study results confirm and significantly extend previous beneficial results showing that subjects with impaired glucose tolerance (IGT) treated with the Generex Oral-lyn™ buccal insulin spray achieved a significant reduction of 0.3% in HbA1c compared to the control group (∆ HbA1c 0'- 6 month -0.3% vs +0.09%, p= 0.002). Although the decrease in body weight in Generex Oral-lyn™ treated subjects did not reach significance in this short term study, there were no reports of hypoglycemia or other adverse events observed during the study period compared to control subjects. These preliminary results suggest that the addition of Generex Oral-lyn™ can be an effective treatment compared to diet and physical exercise alone in subjects with IGT in reducing HbA1c and doing so without adverse effects.

"These results suggest Generex Oral-lyn™ will be an important therapy tool for adults with prediabetes conditions of IGT and elevated blood-sugar levels," said Dr. James H. Anderson, Jr. , MD, FFPM, FACE, Generex's Senior Scientific Advisor. "The opportunity to successfully expand Generex Oral-lyn™'s use beyond Type 1 diabetes and Type 2 diabetes offers a validated therapy to not only treat and improve the quality of life of those who will eventually be diagnosed with diabetes, but also provides a solution for the diabetes medical community to potentially reduce or prevent the progression of the complications that may arise from having diabetes."

Prediabetes is a condition in which individuals have blood glucose or A1c levels higher than normal but not high enough to be classified as diabetes. People with prediabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke. According to the Center for Disease Control and Prevention, it is estimated that in 2010, 79 million people 20 years of age or older have pre-diabetes, and approximately 50% of Americans aged 65 and older have pre-diabetes.

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[Nyk]

Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program

Company Reschedules Conference Call to Early January


..

WORCESTER, Mass. and TORONTO , Dec. 1, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT.OB - News) today provided an update on the status of the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.

Work has been completed on reviewing, validating, re-analyzing (including additional new analyses), and revising all of the extant Generex Oral-lyn™ Clinical Study Reports. In addition, the data collection, analysis, review, and preparation of the final Clinical Study Report for the recently concluded Generex Oral-lyn™ Study 084, A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin In Subjects With Type 1 Diabetes Mellitus, has been completed.

This will allow an on-schedule completion this quarter of Generex's response to USFDA queries (as described during the annual meeting of stockholders in June). The new Generex Oral-lyn™ Investigators' Brochure (required for review and conduct of future Generex Oral-lyn™ studies) remains on schedule for completion, submission to the regulatory agencies of all countries participating in Generex Oral-lyn™ trials, and publication for investigators and ethical review boards in the first quarter of 2012.

The new clinical development plan, including pharmacokinetic and gluco-dynamic studies, a comprehensive clinical phase 3 program (to assure appropriate marketing approval to treat every type of patient with diabetes), and a small number of well-designed physiologic studies to demonstrate the unique advantages of Generex Oral-lyn™ (vital for marketing and reimbursement) will be announced early in the first quarter of 2012. Additionally, a meeting with the USFDA will be scheduled in the first quarter to insure consensus with the clinical plan to help achieve an expeditious regulatory review and marketing clearance.

The Company also announced today that the next investor conference call, initially scheduled for late November, will be rescheduled to early January, 2012. "The Generex management team and its advisors have been working diligently on the previously announced strategic development plan, including the spinout of Antigen Express, the Generex reverse stock split, the stock dividends of Antigen stock to the Generex stockholders, and the clinical and regulatory development programs for Generex Oral-lyn™ and the the AE37 immuno-therapuetic vaccines platform technologies, and significant progress has been made," said Mark Fletcher , the Generex President & Chief Executive Officer. "In order that the investor conference call will be as productive, informative, and useful as possible, we have elected to reschedule the call to a later date when the plan will have achieved greater maturity and specificity so as to be in a position to provide a more comprehensive and detailed report to our stockholders."

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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