José Luís Carneiro considerado o melhor líder para o PS

[Zezezinho]

Boas,

Em relação ao reverse-split, como ficou este assunto ?
Em que dia é que se saberá novidades ?

Já me arrependi de não ter vendido a 0,56.

[AC Investor Blog]

Boas AC:

do ponto de vista técnico consegues fazer uma actualização da generex?

Obrigado

Amigo Pedro,

Estive de mini-férias no Sul, só apartir de amanhã é que volto analisar mercados e titulos.

Boa Noite,

AC

[pedrojcc]

http://pipelinereview.blogspot.com/

[pedro200]

WORCESTER, Mass,, Oct. 5 /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com) announced today a corporate update in a letter to shareholders from Interim President and Chief Executive Officer, Mark Fletcher, addressing management's strategic initiatives for growth. The letter to shareholders reads as follows:

Since I've taken the position of CEO at Generex, the management team has been working diligently to refine its comprehensive plan for the advancement of our current proprietary drug delivery and immunotherapeutic vaccine platforms as well as the Company's strategic vision for future growth. Over the past twelve months, we have seen significant advancements in both of our platform technologies and we are encouraged by our progress.

Since Generex Oral-lyn™, our proprietary buccal insulin spray product, has been the main focus by many audiences following our Company, I will begin by providing a synopsis of that program as well as providing our vision for the future of this important buccal drug delivery platform. I would, however, like to emphasize that when evaluating our Company, one should not overlook the tremendous potential of our immunotherapeutic vaccine technologies which I will also address here in greater detail.

We are currently in an ongoing Phase III clinical trial of Generex Oral-lyn™ and have reported preliminary outcomes and trends in June of this year suggesting a better "Adverse Event" profile than subjects using injectable insulin as well as no weight gain. In fiscal 2010, the safety and efficacy profile of Generex Oral-lyn™ led the Food and Drug Administration (FDA) to grant us approval for the treatment use of Generex Oral-lyn™ in patients with Type 1 or Type 2 diabetes mellitus under the FDA's "Treatment IND" program and later in 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 other studies we have conducted. As we move through the remainder of our Phase III trial, we intend to focus our regulatory approval efforts in the United States, the European Union, and Canada. Generex Oral-lyn™ has been approved for sale in India by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. We entered into a Product Licensing & Distribution Agreement with Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in) pursuant to which Shreya is responsible for the marketing, distribution, and sale of Generex Oral-lyn™ in India. The terms of the Indian government approval required that a post-approval marketing surveillance study be undertaken in India. The CDSCO reviewed the protocol in respect of the study and granted permission for the commencement and prosecution of the study. The study, involving as many as 200 subjects, is well underway and is being undertaken and managed by Shreya. Upon completion of the study, the results will be submitted to the CDSCO in support of Shreya's intention to commence commercial distribution of Generex Oral-lyn™ in India.

The second prong to our strategy is to work with strategic partners to further the development and distribution of Generex Oral-lyn™ as well as other applications of our buccal drug delivery platform. Our recent long-term marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of one of our proprietary consumer/over-the-counter products, Glucose RapidSpray™ (www.glucoserapidspray.com), is just the beginning of what we believe is a tremendous commercialization opportunity for this platform. We continue to be in discussions with a number of companies with regard to potential strategic relationships in this regard, for Generex Oral-lyn™ as well as other diabetic and energy related pipeline products using the buccal delivery platform technologies.

The third prong to our strategy is to work with other pharmaceutical companies to establish the use of our proprietary liquid formulations that allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using our proprietary RapidMist™ device. By using RapidMist™ as a delivery method, we believe we can extend the patent life of injectable drugs near the end of their patent protection, greatly enhancing the value of those drugs.

For our immunotherapeutic vaccine platform, under development at our wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), we are confident that fiscal 2011 will be a year of great advancement in these groundbreaking efforts. We believe the vast potential of our breast, prostate, and other AE37 cancer vaccines are unmined gems for our Company. AE37 is used to generate a specific immunological response to cancers expressing the HER2 oncogene. We are in the midst of a Phase II clinical trial in patients with breast cancer and a Phase I trial in patients with ovarian cancer. In addition, we recently completed a Phase I trial in patients with prostate cancer and are making preparations to move into a Phase II trial. We anticipate our Phase II AE37 trial in breast cancer will be completed in fiscal 2011 and, provided that the study data is consistent with data available to date, we intend to work with the FDA on a plan to conduct a Phase III study for this important vaccine.

We have recently looked to augment our team of scientific advisors as we move our development programs and pipeline of products toward commercialization. We intend to take advantage of their experience and expertise to assist our scientific and management teams and provide advice and guidance in refining our science to enable us to capitalize on our Company's promising future. For Generex Oncology, we have brought in Dr. Craig Eagle, the head of the oncology therapeutic area of the global medical group for Pfizer, Inc., as an advisor to help us navigate through the regulatory approval process for AE37 as well to help us in our strategic partnership efforts within the pharmaceutical community. We have also retained the consulting services of Dr. George M. Peoples, presently the Chief of Surgical Oncology at Brooke Army Medical Center in Houston, TX, a Professor of Surgery and the Director & Principal Investigator of the Cancer Vaccine Development Program at Uniformed Services University of the Health Sciences in Bethesda, MD, and the Deputy Director of the United States Military Cancer Institute (www.usmci.org). Dr. Peoples is providing advice and assistance to us with respect to the design and implementation of a Phase III trial of the AE37 vaccine in patients with breast cancer, and acts as a liaison with the FDA regarding the clinical and regulatory development of the vaccine. We also have engaged the services of a world-renowned independent firm used by many major pharmaceutical companies for intellectual property appraisals, to provide an appraisal of our vaccine technology platform.

As I navigate our Company through this transitional period in management, I feel it is important to communicate to our shareholders that management is committed to bringing our rich intellectual property resources to commercial fruition. We continue to work closely with our business development consultants, including Seahawk Capital, which was instrumental in helping us regain our financial footing in 2009. We intend to seek out unique opportunities to generate meaningful near-term revenue streams. We are confident that, together with our board of directors, our in-house scientific team, our scientific and business development advisors, and everyone associated with our Company, we are well-positioned for, and more focused than ever on, achieving our goals.

As I am sure you are aware, we are at a pivotal point in our Company's history and you are faced with an important decision. The price of our common stock is below $1 per share and we face an imminent NASDAQ delisting should our shareholders elect to vote down a proposed reverse stock split. While I fully understand the reservations you may have regarding this proposal and we will continue with our business development strategies without regard to your final decision, management believes that it is in the best interest of our Company and its shareholders to approve the proposal. We believe that by maintaining the NASDAQ listing we will be better able to attract top caliber talent to our Company as well as maintain a stronger standing in the business and financial community. We intend to communicate further on this subject prior to October 15th as we work to position Generex for the future.

In closing, I would once again like to emphasize that each and every employee and all those associated with Generex are dedicated to achieving success. As we forge ahead, I intend to make every effort to guide us toward our promising future. Generex is a company rich in intellectual properties, technologies, and talent, with tremendous growth potential, and together we will realize that potential for the benefit of our Company and its shareholders.

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. The Company's flagship product, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Safe Harbor Statement

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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

[pedro200]

Boas AC:

do ponto de vista técnico consegues fazer uma actualização da generex?

Obrigado

[pedro200]

http://vfcsstockhouse.blogspot.com/

Generex Biotechnology Corp. made TheStreet.com's biotech blog once again on Friday, although the biotech blogger's comments were a bit more civilized than past comments, but that might have to do more with the $250 million lawsuit that Generex filed against TheStreet.com than an actual lightening of heart.

Regardless of the reasons for the lightening of tone, Feuerstein - who is TheStreet.com's blogger and seemingly a puppet for some bigger players who pull the strings - still managed to hit replay on his all-out negative assault of Generex - an assault that never started until Mannkind received bad news regarding its insulin-spray earlier this year. It was that suspicious timing that drew curious eyes to the true motives of TheStreet.com, as Generex had been - for the most part - left alone until Mannkind went south.

Now we're to understand that even though Feuerstein likes the removal of Anna Gluskin as CEO of the company, that there's no possibilities of positive developments for Generex. They've simply got no chance - just ask the biotech blogger.

It's true, there are two sides to every story, and the astute investor must respect both sides, but the biotech blog has a track record of only telling the negative side of the story - because it's easier that way and fits right into whatever ulterior motives may be conived behing the scenes. If you remember, Dendreon (DNDN) had no chance either.

In a slippery sort of way, Feuerstein tells his readers that the only way that GNBT can stave off a delisting from the Nasdaq is by a reverse split - no mention of the fact that if the stock price were to meet listing standards in the near future, then it could continue to trade with no problem on the big board.

Is that a likely event? That's debatable, but it's possible - and the thought should be entertained when summing up the risk/reward of this particular stock.

As I discussed in my last post about the shakeup at Generex, there are quite a few theories out there of what went on behind closed doors to lead to the ouster of the company's CEO - some positive, some negative - but it's obvious that Feuerstein doesn't know any more than you or I - but he wants you to believe that it could only be bad for the company and shareholders.

The tone may be softer - again, probably due to the lawsuit - but the irresponsible blogging (only Feuerstein himself considers what he does as journalism) and disregard for the facts or both sides of the story continue.

It's up to the reader to determine why he or she believes TheStreet.com likes to attack particular companies - and then decide if TheStreet.com's involvement has any thing to do with the fishy trading that goes on with those companies.

Don't be fooled, and I wouldn't waste my time at that website.

Disclosure: Long GNBT.

[pedro200]

Big Changes at Generex Biotechnology
Yesterday, shareholders of Generex (GNBT) Biotechnology were startled to learn that the company's Board of Directors ousted co-founder and long time President and Chief Executive Officer Anna Gluskin. The Board of Directors appointed their Generex Counsel and VP Mark Fletcher as Interim President and Chief Executive Officer. Ms Gluskin was also replaced as Chairman of the Board by John P. Barratt. Mr Fletcher has served as Generex's Executive Vice-President and General Counsel since joining the company in April 2003, while Mr Barratt has chaired the audit and compensation committees of the Board since 2003. This change comes at a critical time of Generex's development.

Background

Ms Gluskin, along with co-founders COO Rose Perri and the late Mark Perri, incorporated Generex in 1997, and she has served as CEO and Director since that time. Their original goal was to develop proprietary formulations of large molecule drugs that can be administered through the buccal mucosa to eliminate or reduce the need for injections. They focused their efforts at developing a liquid version of human insulin, originally called Oralgen, through the inner cheek wall to validate their delivery system. The first patent applicable to their large molecule delivery technology was issued in the US on January 25, 2000. Last week, we learned that a newly issued patent increased the number of issued patents related to the company’s buccal drug delivery platform technologies to 161 and a total of 102 patent applications remain pending. Oralgen is now called Oral-lyn, and it has been successfully developed deep into a worldwide Phase III trial, and is the first diabetes developmental drug approved by the FDA to be available through a Treatment IND program.

Ms Gluskin, as CEO of Generex, also had the vision in 2003 to aquire a promising life science firm, Antigen Express, that was developing immunotherapeutic peptide based vaccines from the labs of the University of Massachusetts. The promising vaccine science had not yet been studied in a single human clinical trial, and today their lead vaccine is in a Phase II efficacy study under a clincal trials agreement with the United States Military Cancer Institute. The vaccine has yielded extraordinary positive interim results in patients with HER2/neu breast cancer patients, and also has been evaluated in a positive Phase I trial for prostate cancer patients. This wholly owned subsidiary has also undertaken a Phase I study utilizing their Ii-Key hybrid technology to protect against avian influenza, and has an ongoing collaboration with France's Stallergenes to create a novel approach for the control of both dangerous forms of asthma and functionally disabling allergic reactions. None of these studies may have been possible if not for Ms Gluskin's ability to fund their efforts.

Unheralded Success Meets Unsuspected Coup

In my book, all three aspects of Generex demonstrate remarkable and rapid achievement for a start up biotech; in drug delivery, in developing a new drug that will greatly benefit the lives of millions of diabetics, and in harnessing great potential value in a struggling life science firm. In other words, Ms Gluskin's tenure at Generex has seen great advances and has positioned the company to be on the cusp of revolutionary medical advancement. However, this week we see a revolution of a different kind. Due to the fickle nature of the stock market, which serves as an unfortunate and inaccurate barometer of achievement for publicly traded research and development biotech firms, Generex ticker is struggling and faces delistment from the Nasdaq Capital Market. There are many valid opinions, both pro and con, relating to Ms Gluskin's efforts as CEO of Generex, but in my opinion she deserves a far greater fate than the one issued by Generex's Board of Directors.

Change can be a good thing, and as small biotechs progress in their development to a period when partnerships can be gained, or when Western commercialization draws to the point of being a reality, we often see senior level management positions be relinquished to others that hold greater levels of experience. Even company founders, a special breed of management, understand and often initiate this type of change. For Generex, I find the circumstance to surround the change to be less appealing and far too quick. Many may disagree, but as a long time and supportive shareholder I disapprove of their handling of this delicate issue.

I do know that Ms Gluskin was out of the country for a couple of weeks, and during the time that the Board of Directors chose to remove Ms Gluskin from her duties. She returned to Toronto, home of Generex's corporate headquarters, one day after their decision was made. I find that tawdry. Can we call that a coup? I would be more empathetic with their decision, and I acknowledge I have no way of knowing why their ultimate decision was made, if they sat down with her and faced her in person. They did not do this, and I ask why? In the company issued press release, new Board Chairman John Barratt, whom I have met, stated that "the Board has concluded, however, that Generex has reached a stage in its maturation where new senior management leadership is now needed for the company to capitalize more effectively on the opportunities that we believe are available to the company." That all sounds well and good Mr Barratt, but why the coup? And why are shareholders left speculating for answers?

Capitalize on Opportunity

I believe that Ms Gluskin was positioning the company to be in a position "to capitalize more effectively on the opportunities" that the Board of Director's "believe are available to the company." I have had the unique opportunity to meet one of Generex's consultants, Joseph Moscato, a Senior Partner at Seahawk Capital, who also introduced me to one of the members of their scientific advisory board. I blogged about that experience earlier which you can read here. Mr Moscato gave me great hope, and I used that experience to fully understand the vision that Ms Gluskin was preaching where a small R and D biotech can seek out ways to earn revenue to offset sky rocketing development costs.

Beyond capital raising activities, Mr Moscato helps small firms such as Generex find unique business opportunities that typically are out of their grasp. I know he worked closely with Ms Gluskin, and it is imperative that the Board continue in working with him to avoid falling back into the same trap of PIPE debt and discounted offerings that plagued Generex shareholders and which were approved by this same group of Board members numerous times during the company's earlier years. It was not until the Spring of 2009, when Ms Gluskin brought in Mr Moscato and his NYC based firm, that this cycle of toxic offerings ceased. In my opinion, this relationship, which may hang in the balance, must continue.

Grace and Respect

Grace and respect are not often associated with the stock market, and I am naive to be disappointed that I do not recognize either in the way the Board of Directors handled this affair. I have long been an outspoken and supportive shareholder of Generex, but my support was grounded by the vision I shared with both Ms Gluskin and Ms Perri. The problem I face as a shareholder is that I do not know if Mr Fletcher or Mr Barratt realize and share the same understanding that no matter how uneven or rocky the road we are traveling, as we fulfill the vision of the founders and the late Mark Perri, we do know that we are embarked on a course that may revolutionize how diabetes and early stage cancer is treated.

Change may be needed, and when it is needed may be not something I can recognize, but I can recognize walking with a lack of respect and grace. I view Generex as mine, and I am proud to own my shares. The Board of Directors may not recognize it, but we will all benefit when Ms Gluskin succeeds in seeing her vision fullfilled. We now move forward, and may the next steps be taken with greater regard. Walk with grace, treat with respect, and never forget the original vision that created the company.
Posted by R J Steffens at 6:02 PM

[pedro200]

Little Update
I posted the following on digitaltradz, and I will insert it here. It serves as an update to my previous blog. I wrote this fast on the digi forum, so excuse me if it is not particularly well written. I thought others that are following Generex's recent developments may find it of interest.

It is unfortunate, but Ms Gluskin did not know that her tenure was to come to an abrupt end. Joe M was also surprised, and when I talked with him yesterday, he was getting ready to fly to Toronto to speak to the team at Generex. It was Joe that brought in Dr Rubinfeld and Dr Eagle. They work on the same block in NYC, and Joe is originally from Pfizer, and they do meet regularly. Even Col Peoples remarked to me about Joe, so I was very relieved to get in contact with him again tonight. He was still with Mr Fletcher and Joe handed Mark the phone. I was open and honest about my disappointment in how the news played out. He agreed. The independent Board members acted on their own. I told him the shareholders feel left in the dark, and it sounds like he and Rose felt the same way. He said that this was very difficult, because they have worked with Ms Gluskin for so long, and have a great rapport. I got the feeling that this was most hard on Rose, since she was like a sister to Ms Gluskin. I asked about Rose, because I feel like I have gotten to know her pretty well via my annoying emails. I am told she is a professional who is on board for the long haul. I told Mark that perceptions play a role, and he told me that he will be updating very soon and wants to open himself up to shareholder dialogue. He knew I was unhappy, and he said that they are all rallying together with strong spirit and have great visions of the future, as well as for the near term. This must be communicated, and they needed a few days to sort out and refocus since they were caught off guard. I never talked to him before, and he seemed to avoid me at the ASM because I had given him a very hard time via email communications leading into the week of the meeting. I told him tonight that my concern was his long term vision, and he reassured me that they are in alignment with my own. We talked for quite awhile, openly about my opinions, and with passion about prospects for the pipeline. He expressed great confidence that we will all be pleased with what they can accomplish, and he said Generex is his life. I told him I really liked Joe and what he saw for Generex, and how he can serve to bring them great opportunities.

Joe, who is disappointed about Ms Gluskin, was renewed and is in full support of Mark. They spent the day together, and all of the scientific advisors, who believe in the pipeline and who are Joe's guys, are all stepping up in support of Mark. I say Joe's guys because he is the one that brings them in as part of his business development capacity. He kept telling me he is 1000% behind Mark, and they are going full out to advance the company. I don't just agree, and I don't just start to clap. Joe knows that, and he also knew I was not pleased yesterday. But they flipped me, and only after back and forth conversation. I do wish Ms Gluskin could have served out as CEO and been treated differently by the Board. All three Board members heard that from me with a lot of disdain. I already know Joe was someone that can make things happen. Shoot, he brought TC and I to dinner and introduced us to Dr Eagle. I told Mark that he is an unknown quantity to me. I have to say, he impressed me with how he handled my concerns and with his enthusiasm for Generex's prospects. I think he is going to make some real headway. I can't believe it, but now I am pretty excited to see what they can do. I said I would never support him, and I was wrong. I am following Joe and am 1000% behind Mark and rooting him on. The guy sounded real, and I was pleased to hear that he will be communicating all of this to all of you. I don't know in what capacity, but it sounds like they just needed a few days. They are working Sat and Sunday, and said that is because they are going all out to turn things back around.
Posted by R J Steffens at 7:43 PM

[pedro200]

só há explicações a subir ? e a descer não há ? já voltou a 0,45, e agora ?

para onde vais gnbt ?


eu, independentemente das cotações contraditórias, acredito na gnbt. A maior fatia dos gastos em saúde em todo o mundo é nos tratamentos oncológicos. A gnbt anda a roçar o sucesso... e se isso acontecer vai ser imediatamente comprada a qualquer preço...

- Muitas notícias podem sair a qualquer momento. Circulam muitos rumores na net, blogs, etc. Transacções estranhas têm acontecido. Na quinta-feira, por volta das 20h40m, aconteceu uma passagem de aproximadamente 1,5 milhões de acções (mais ou menos, não me lembro bem).

Bom fim-de-semana

[pvg80713]

só há explicações a subir ? e a descer não há ? já voltou a 0,45, e agora ?

para onde vais gnbt ?


eu, independentemente das cotações contraditórias, acredito na gnbt. A maior fatia dos gastos em saúde em todo o mundo é nos tratamentos oncológicos. A gnbt anda a roçar o sucesso... e se isso acontecer vai ser imediatamente comprada a qualquer preço...

[pedro200]

http://www.thestreet.com/_yahoo/story/1 ... &cm_ite=NA

Biotech Stock Mailbag: Generex

Adam volta a atacar!

[pedro200]

Friday, October 1, 2010
A Shakeup at Generex, Partnership on the Way?


The foundations of Generex Biotechnology Corp shook in Worcester on Wednesday as it was announced that co-founder and long time President and CEO Anna Gluskin was removed from her positions and replaced by Mr. Mark Fletcher, Generex's Executive Vice-President and General Counsel since 2003. Mr. Fletcher's appointment was on an interim basis.

In another move, John P. Barratt, previously serving as an independant director, was asked to serve as Chairman of the Board.

Ms. Gluskin will continue to serve as Director of the company.

The little guys are never going to know what went on behind closed doors in Worcester to lead to the removal of Anna Gluskin as CEO, but there will be a whole lot of speculating taking place. Some speculation has it that Anna was forced out for being a roadblock to potential big-pharma partnerships, while others speculate that Ms. Gluskin was solely looking to boost her personal share of the company by pushing through the reverse split that never seemed to muster enough votes to be exercised.

Let's highlight some important quotes from the press release:

Mr. Barratt said, after recognizing Anna's past achievements, "The Board has concluded, however, that Generex has reached a stage in its maturation where new senior management leadership is now needed for the company to capitalize more effectively on the opportunities that we believe are available to the company. We believe that a tighter focus on the company's core business is needed and we have determined that this can only be achieved under a new President and CEO,"


VFC's Translation: It should be assumed that by "core business" Mr. Barrat means Oral-lyn and its delivery system, since the cancer and flu vaccine pipelines are being developed by a subsidiary. If that is actually the case, then I think that Mr. Barrat - and the rest of the Board for that matter - believe that partnerships and/or licensing deals are available - and available right now - for Oral-lyn and any associated products that may utlitze the buccal drug delivery system through the inner lining of the cheek.

Anna Gluskin may have been perceived as a threat to allowing any potential deals to materialize, whether it was because she wanted Generex to enjoy 100% of all potential Oral-lyn sales and refused to deal or whether it was because she was intent on allowing an R/S to go through. Regardless of her reasoning, it also looks like it became painfully obvious that the share price was not going to reach the one dollar mark in quick time with Gluskin on watch.

The R/S was tried and failed, and then the PR barrage also failed; that meant it was time for a change in management, in my opinion, because it looks obvious that the rest of the Board has a plan that Anna just didn't want to put into motion.

Also, what do we make of "it maturation"? What has Generex matured into that Mr. Barratt knows and we don't? Curious.

"I will work with the Board to develop and execute growth strategies that focus on our strengths. I intend to maintain the many important partnerships that we have forged internationally with respect to the development and commercialization of our drug delivery systems and technologies," Mr. Fletcher said.


VFC's Translation: Mr. Fletcher thinks that there are partners out there, and he thinks he's going to get a deal done. I believe that "our strengths" are Oral-lyn and the drug delivery system.

Whatever the reasons behind the Gluskin ouster, Generex is still proving to be a company that never allows for a dull moment.

There is another side to the speculation, other than what I've already mentioned. This could be another posturing by the company to buy more time from the Nasdaq while they try and get the stock price to a buck. Since the PR barrage didn't do it, and since it doesn't look like the split is going to occur, this may be a last ditch effort to show the Nasdaq that the Board is doing something in order to return to compliance.
While possible, I don't believe that the tone of this email supports this scenario. I think the tone said, "It's time for a change - let's get a deal done."

Another possibility is that the Phase III results are still straddling the line between success and failure and the Board wants to sign a big partner now - before results are released - just in case they end up needing addtional financing to conduct an additional trial or gather more data. Anna may not have felt a need to sign a 'crutch' right now for the 'just in case' scenario, but the Board might feel it necessary to stave off a complete collapse if this trial doesn't turn out quite as planned.

As I said, speculation will be rampant, and these are only a few theories - we won't know the truth until it appears on the news wires.

Which theory is VFC buying into? It may not have been a hostile coup, after all, Anna is still the Director, but I think she was forced out and given the option to remain on in some capacity. I think that the Board saw her as a detriment to progress, acted on it, and are now prepared to move Generex into the next phase of development.

We've seen Generex announce a couple of big partners over the last month, so let's see if we get the one that matters most - the Oral-lyn partner.

Never a dull moment around here, that's for sure.

Disclosure: Long GNBT.

[pedro200]

Pedro, pela enésima vez: isto não é um relato de futebol... Quem quiser consultar as cotações escolhe outros sítios que não o Caldeirão.

Tens razão! Sorry! Apaga por favor a minha mensagem.

[Ulisses Pereira]

Pedro, pela enésima vez: isto não é um relato de futebol... Quem quiser consultar as cotações escolhe outros sítios que não o Caldeirão.

[José_P.]

E se não passar?

[pedro200]

Atenção:

ordens a entrar continuamente no sistema e a pressionar a cotação para cima! 0,52 neste momento!se passar os 0,53 pode disparar!

[pedro200]

http://finance.yahoo.com/news/Generex-B ... ?x=0&.v=16


Generex Biotechnology Appoints Mark Fletcher as Interim President and CEO, and John P. Barratt as Chairman of the Board


"I will work with the Board to develop and execute growth strategies that focus on our strengths. I intend to maintain the many important partnerships that we have forged internationally with respect to the development and commercialization of our drug delivery systems and technologies."

[Shevet]

http://seekingalpha.com/article/227286-generex-do-development-drug-companies-have-no-value

Muito positivo este artigo, principalmente o que toca à possivel entrada da Pfizer

The valuation of small development companies is always a bit of a challenge. While I am not necessarily surprised by the low share price of Generex (GNBT) because of the things managements of small development companies have to do to raise money to continue the research, I submit the prospects of small companies, in this case Generex, are not nothing, which is close to market's recent valuation.

For the stock market, there appears to be no continuum to valuations, which seems a bit irrational.

The day before the FDA announcement, Dendreon (DNDN) was worth $400 million at its low point in 2009, and now currently bears a market cap of $6 billion. Next to this valuation Generex's little over a hundred million market cap (a measly 2% of DNDN's, is, in any practical discussion, nothing, or next to it. Perhaps there was not enough information prior to make more of a continuum evalutation in Dendreon's case, but I think there is such a case to be made for Generex. But even so, Dendreon's pre-event valuation was three or four times Generex's current valuation.

Generex has a market cap of only $126 million. It is working on a prostate vaccine, which worked so well for Dendreon, but also a vaccine for breast cancer, avian and swine flus, ovarian cancer, and melanoma.

But this is not even their main push, which is a drug delivery system in which drugs are passed to the blood system via the buccal tissue inside the mouth. Their test case is insulin. Recent testing demonstrated that insulin passed to the blood system through the inside-the-mouth route did not generate antibodies. Antibodies are the body's way of rejecting a substance and in diabetes this is called insulin resistance. Good news for this start-up.

If the test case works, then this technique may be applied to many other drugs. The message boards were rampant with the notion that Pfizer (PFE) might want to buy Generex just to develop a spray for Viagra that would become effective much quicker than the half hour it takes now, and give them some additional patent protection time.
Certainly, Generex deserves to be rated at the $400 million of the pre-approval Dendreon. I would argue it deserves to rated at considerably more, perhaps twice as much.

Mannkind (MNKD) is working on many of the same kinds of things as Generex, but it has a market cap of $690. That's five times the market cap of Generex. It is also working on the problem of insulin delivery. But theirs is a much, much riskier proposition. First, Mannkind must get FDA approval of its drug Affreza, Generex does not need any drug approval, it is using regular insulin. But even more risky than this is that Mannkind's scheme uses absorption through the lung. Pfizer had a drug for lung absorption, Exubera, but they shelved it, and wrote down a staggering $2.8 billion because patients were not inclined to use it. Generex's offering Ora-lyn does not go in the lungs.

Mannkind is also working on cancer vaccines. I cannot speak to their program, but I can say that the head of cancer drugs for Pfizer, Dr. Craig Eagle, has begun to advise Generex on its cancer vaccine program.

To be fair, we sometimes get fooled. I had invested in Northfield Labs because it had a blood substitute based on the hemoglobin molecule, the base blood molecule, but it failed to meet a non-inferiority test of blood plus saline. It worked pretty well, but it did not meet that test. (I'm not going to get into a discussion of the FDA's methods. But what if blood plus saline is not available? Then "pretty well" might be a good thing to have.)

If Ora-lyn fails, this will be a horrible day for diabetics, and horrible day for Generex stockholders, though at current levels, not that horrible. They still have the vaccines. And if the vaccine fails for cancer, it may still work for avian flu or swine flu, and that may still make the company more valuable than Mannkind.

And that's my contention, Generex is worth at least as much as Mannkind, which would make Generex worth $2.60 per share. Now. Today. And I think it's worth more. To reiterate, its risk on the insulin product is one third of Mannkind's (no drug approval needed, and not going to the lung). By rights, it's worth a good deal more than Mannkind.

Abraço
Shevet

[Peftoulas]

Generex Awarded a New Patent in Canada for its Proprietary Buccal Drug Delivery System


New patent covers method for preparing pharmaceutical compositions and methods for enhancing the rate of absorption

WORCESTER, Mass., Sept. 28 /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq: GNBT, www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has been awarded a new patent in Canada.

The Canadian Intellectual Property Office granted Canadian Patent No. 2,401,942, a patent titled "Pharmaceutical Compositions for Buccal and Pulmonary Application".

This new patent increases the number of issued patents related to the Company's buccal drug delivery platform technologies to 161. A total of 102 patent applications remain pending.

"We are pleased that we continue to establish the inventiveness of the Company's buccal delivery system as there has been relatively little progress over the years in reaching the target of safe and effective oral formulations for macromolecules, including peptides and proteins", stated Rose C. Perri, the Company's Chief Operating Officer. "We are pleased that we continue to receive patents from key markets within which our delivery system can be commercialized with a pipeline of viable applications that will open up other marketplaces for the Company".

[pedro200]

Pedro,

Vê lá isto : http://www.grecale.org/1/generex_biotec ... 58371.html

Bom Dia AC,

Obrigado pelo Link!
com tanto trabalho nem tenho tido tempo de entrar no caldeirão.

De uma forma geral a informação que está nesse link, já conhecia! O video que está nesse site já coloquei aqui no forum várias vezes.

Outro facto importante e que já sabia (pois ando atento) é a seguinte:

Al 33° SABC San Antonio Breast Cancer Symposium (8-12 dic. 2010) verrà presentato un abstract con il quale si darà avvio ad una sperimentazione in fase II dei 2 vaccini assieme:

Combination Immunotherapy for Breast Cancer Patients: Safety and Immunologic Data from a Phase II Trial Administering a HER2/neu-Derived Peptide vaccine (AE37+GM-CSF) Sequentially or Concurrently with Trastuzumab in the Adjuvant Setting

http://www.sabcs.org/ProgramSchedule/Po ... GroupID=79

Un’altra collaborazione simile avviene con il Neuvax (E75 dell’Aphtera) che non avendo una robusta risposta immunitaria si avvalla delle capacità dell’AE37

“Increased potency of HER2/neu(776-790) MHC class II epitope linked to Ii-Key in stimulating T-cell responses and co-inducing CTL responses to E75 peptide in PMBC of breast cancer patients with HER2/neu-positive compared with HER2/neu-negative tumors.”

Collaborazioni come queste ne potrebbero uscire molte e questo ha spinto la Generex a brevettare il peptide originario HER2 con la proteina li-key:

mas não estava a par disto:

Il 5 ottobre a Vienna al 4° Global Vaccine Conference, E. von Hofe presidente di Antigen, illustrerà la nuova strategia dei vaccini anticancro che stimolano la produzione dei CD4+

Tuesday 5 October 2010
Cancer Vaccines and other Novel Vaccines
11:35 – 11:45

[B3.3] Novel vaccine strategies for cancer and infectious diseases by stimulating antigen-specific CD4+ T helper cells.
M. Xu*, X. Lu, D. Powell, N. Kallinteris, E. von Hofe, Antigen Express, Inc, USA


http://www.vaccinecongress.com/programme.asp


As proximas semanas prometem!

Thanks!

Cumprimentos

[pedrojcc]

http://seekingalpha.com/article/227286- ... e-no-value

[AC Investor Blog]

Pedro,

Vê lá isto : http://www.grecale.org/1/generex_biotec ... 58371.html

[pedro200]

Pedro,

Tecnicamente perfeita. Repara no indicador de accumulação.... Hoje ou 2ªfeira o titulo deve voltar ás subidas, á conquista dos $.55. Podemos ter mais um ou dias de consolidação....

Sim, Também reparei! Tecnicamente a generex está perfeita! As quedas nas duas últimas sessões serviram para a acção "respirar" um bocado. E as "Weak hands" abandonarem o barco. A reunião para a votação do Reserve Split está marcada para o dia 15 de Outubro. Para evitar isso seria imprtante que rapidamente a gnbt atingisse os 1! Parece impossível? Vamos esperar..... Se a Pfizer entrar em campo.... vai ser bonito....

Leram o Abstract da EASD2010? Aconselho a lerem as conclusões! A Apresentação do Poster da gnbt foi ontem à tarde!! Estiveram lá a nata dos investigadores da área!!! (sabiam que para o ano o EASD2011 é em Lisboa!!!! as tantas a generex bem cá a lisboa.... e se as coisas correm bem, já com a aprovação da FDA do Oral-Lyn!)

Além de seguir a gnbt, é importante seguir o que se passa com a MNKD! é a luta por um mercado de bilhões!

[AC Investor Blog]

Pedro,

Tecnicamente perfeita. Repara no indicador de accumulação.... Hoje ou 2ªfeira o titulo deve voltar ás subidas, á conquista dos $.55. Podemos ter mais um ou dias de consolidação....

[pedro200]

Curiosidade:

ontem, quando faltava poucos minutos para a sessão terminar houve uma passagem de 1,1 milhões de acções!

não é muito normal....

fica a informação!