gnbt - momento da verdade
http://insighteyesofthemind.blogspot.com/
Sunday, September 12, 2010
Hedging in a Weak Economy
I often thought, during the 1990s, that an ideal hedge would be to short General Motors and buy Toyota. GM was on a death spiral that was hard to miss, and Toyota built some of the best cars in the world. I owned one at the time. It turned out to be a winner of an idea, but at the time I was too enamored of my ten baggers: Viropharma, Human Genome, Incyte. Why bother with a hedge? As Steve Cohen recently said of the 1990s in Vanity Fair, all you had to do was show up.
But this is another time, and perhaps we should be developing new strategies, you know, reinventing ourselves. We know now that this is a downside, Virginia.
I am proposing a new hedge. The players are Generex (GBNT) and Mannkind (MNKD). I would go long Generex and short Mannkind. They are both involved in similar biotech plays. Both are working on insulin, both have delivery systems they are working on, and both are working on cancer vaccines.
Mannkind is trying to get approval for Afrezza, an insulin product which would be taken using one of their inhalers into the lung. Pfizer took a $2.8 billion write down on Exubera, their insulin solution for lung absorption. Patients and doctors did not like it. And that was the only reason for Pfizer's discontinuing it. Perhaps they were afraid of residues or lung problems, but they were not the reason for dropping it. Now comes Mannkind, spending more money on a lung absorbed insulin, and the FDA is not saying no, but they are questioning the "utility" after having seen the Pfizer dropped for lack of interest.
Generex is also trying to solve the insulin problem. But they are not testing any new drug, they are simply using regular insulin. However, their trick is to get it absorbed in the buccal tissues inside the cheek. Nothing goes inside the lung. It is based on the principle of nitroglycerin for heart patients. You put it under the tongue, and soon it is in the blood stream. They are in Phase III, and while one never knows about these things, it's looking okay so far.
But it is important to remember they are only testing a delivery method, not a new drug. Generex has tried the delivery method with other drugs, and the message boards were recently full of gossip about Pfizer buying the company to speed the delivery of Viagra, which in the pill form takes half an hour to kick in. It becomes more interesting gossip when you realize that this is yet another of Pfizer's blockbusters to come off patent soon. Would they pay to get patent protection for a form that would kick in right away? I don't know, but maybe.
Pfizer is already in the picture at Generex, their chief of oncology drugs is Dr. Craig Eagle, and he has recently joined Generex as an advisor on their AE37 vaccine, which apparently he thinks has chances. It has been in tests for the big cancers - prostate and breast, and so far so good. It is hard to get extremely hopeful about these things until you get past Phase III, and Pfizer may very well wait it out.
Though if I were Pfizer I'd be looking with equal interest, if not more, at the insulin spray, having blown $2.8 billion on inhaled insulin. I'd just consider that prudent risk management.
It is hard to imagine Pfizer, or any other major Big Pharma company, taking an interest Mannkind's persistent pursuit of a lung-absorbed product that not only Pfizer, but Lilly and Novo-Nordisk have dropped.
I cannot speak to Mannkind's cancer vaccines. They are not working on the big ones, but even a melanoma vaccine would skyrocket the stock, and be a terrific boon to cancer sufferers. And might well deep six this hedge.
But it seems to me that Mannkind's pursuit of lung-absorbed insulin is foolhardy in light of patients rejection of the method. Generex's buccal spray looks like the future. And if the vaccine works, it will become Big Pharma itself.
Sunday, September 12, 2010
Hedging in a Weak Economy
I often thought, during the 1990s, that an ideal hedge would be to short General Motors and buy Toyota. GM was on a death spiral that was hard to miss, and Toyota built some of the best cars in the world. I owned one at the time. It turned out to be a winner of an idea, but at the time I was too enamored of my ten baggers: Viropharma, Human Genome, Incyte. Why bother with a hedge? As Steve Cohen recently said of the 1990s in Vanity Fair, all you had to do was show up.
But this is another time, and perhaps we should be developing new strategies, you know, reinventing ourselves. We know now that this is a downside, Virginia.
I am proposing a new hedge. The players are Generex (GBNT) and Mannkind (MNKD). I would go long Generex and short Mannkind. They are both involved in similar biotech plays. Both are working on insulin, both have delivery systems they are working on, and both are working on cancer vaccines.
Mannkind is trying to get approval for Afrezza, an insulin product which would be taken using one of their inhalers into the lung. Pfizer took a $2.8 billion write down on Exubera, their insulin solution for lung absorption. Patients and doctors did not like it. And that was the only reason for Pfizer's discontinuing it. Perhaps they were afraid of residues or lung problems, but they were not the reason for dropping it. Now comes Mannkind, spending more money on a lung absorbed insulin, and the FDA is not saying no, but they are questioning the "utility" after having seen the Pfizer dropped for lack of interest.
Generex is also trying to solve the insulin problem. But they are not testing any new drug, they are simply using regular insulin. However, their trick is to get it absorbed in the buccal tissues inside the cheek. Nothing goes inside the lung. It is based on the principle of nitroglycerin for heart patients. You put it under the tongue, and soon it is in the blood stream. They are in Phase III, and while one never knows about these things, it's looking okay so far.
But it is important to remember they are only testing a delivery method, not a new drug. Generex has tried the delivery method with other drugs, and the message boards were recently full of gossip about Pfizer buying the company to speed the delivery of Viagra, which in the pill form takes half an hour to kick in. It becomes more interesting gossip when you realize that this is yet another of Pfizer's blockbusters to come off patent soon. Would they pay to get patent protection for a form that would kick in right away? I don't know, but maybe.
Pfizer is already in the picture at Generex, their chief of oncology drugs is Dr. Craig Eagle, and he has recently joined Generex as an advisor on their AE37 vaccine, which apparently he thinks has chances. It has been in tests for the big cancers - prostate and breast, and so far so good. It is hard to get extremely hopeful about these things until you get past Phase III, and Pfizer may very well wait it out.
Though if I were Pfizer I'd be looking with equal interest, if not more, at the insulin spray, having blown $2.8 billion on inhaled insulin. I'd just consider that prudent risk management.
It is hard to imagine Pfizer, or any other major Big Pharma company, taking an interest Mannkind's persistent pursuit of a lung-absorbed product that not only Pfizer, but Lilly and Novo-Nordisk have dropped.
I cannot speak to Mannkind's cancer vaccines. They are not working on the big ones, but even a melanoma vaccine would skyrocket the stock, and be a terrific boon to cancer sufferers. And might well deep six this hedge.
But it seems to me that Mannkind's pursuit of lung-absorbed insulin is foolhardy in light of patients rejection of the method. Generex's buccal spray looks like the future. And if the vaccine works, it will become Big Pharma itself.
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
WORCESTER, Mass., Sept. 14 /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq: GNBT; www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has entered into an exclusive Product Licensing & Distribution Agreement with PMG S.A. (www.pmgpharma.com) for the registration, marketing, distribution and sale of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, in Chile.
PMG PHARMA is a Chilean pharmaceutical corporation located in Santiago and focused in three therapeutic areas: diabetes, nephrology and an injectable product line sold in hospitals and pharmacies. PMG PHARMA represents fifteen international companies, all related to its core business in diabetes. PMG PHARMA's principals include the managing board comprised of a General Manager, a Marketing Manager, and a Sales Manager, each of whom have extensive experience in the diabetes space. Some of their achievements include successfully introducing the blood glucose monitoring system from Boheringer Manheim (now known as Roche) in Chile as well as introducing Novo Nordisk's monocomponent insulin and human recombinant insulin (including the NovoPen®) in Chile. This long history will in the diabetes segment will provide a solid platform for Generex Oral-lyn's™ market introduction in Chile.
Chile has a population of over 16.8 million and a diabetes prevalence of 7.2% (per the International Diabetes Federation). Patients under insulin therapy are estimated to be approximately 85,000.
"We are delighted to have licensed Generex Oral-lyn™ to PMG PHARMA, a well-established company whose principals have a long history in marketing diabetes products," said Anna Gluskin, Generex's President and Chief Executive Officer. "This alliance is important as it opens up another key country in South America where diabetes is a highly prevalent condition."[quote][/quote]
PMG PHARMA is a Chilean pharmaceutical corporation located in Santiago and focused in three therapeutic areas: diabetes, nephrology and an injectable product line sold in hospitals and pharmacies. PMG PHARMA represents fifteen international companies, all related to its core business in diabetes. PMG PHARMA's principals include the managing board comprised of a General Manager, a Marketing Manager, and a Sales Manager, each of whom have extensive experience in the diabetes space. Some of their achievements include successfully introducing the blood glucose monitoring system from Boheringer Manheim (now known as Roche) in Chile as well as introducing Novo Nordisk's monocomponent insulin and human recombinant insulin (including the NovoPen®) in Chile. This long history will in the diabetes segment will provide a solid platform for Generex Oral-lyn's™ market introduction in Chile.
Chile has a population of over 16.8 million and a diabetes prevalence of 7.2% (per the International Diabetes Federation). Patients under insulin therapy are estimated to be approximately 85,000.
"We are delighted to have licensed Generex Oral-lyn™ to PMG PHARMA, a well-established company whose principals have a long history in marketing diabetes products," said Anna Gluskin, Generex's President and Chief Executive Officer. "This alliance is important as it opens up another key country in South America where diabetes is a highly prevalent condition."[quote][/quote]
- Mensagens: 41
- Registado: 18/11/2009 17:58
- Localização: 22
AC Investor Blog Escreveu:Pedro,
Sabes alguma coisa sobre a GNBT, disparou á minutos com grandes compras. Não consigo encontrar feeds de noticias... já vai nos 7% e com grandes ordens de compra.
Bom dia AC!
só agora reparei na tua questão.
Realmente na passada sexta-feira em alguns segundos entraram no sistema grandes ordens de compra que fizeram a acção disparar.
Durante a próxima semana (dia 17) vamos ter a reunião dos accionistas da generex. Se leres atentamente a ordem dos trabalhos podem surgir algumas supresas... principalmente no ponto 3 da agenda da reunião. Além disso, os rumores de uma possível parceria com a Pfzer ou a Merk para o oral lyn e/ou Ae37 podem estar a fazer com que grandes investidores estejam a acumular acções da gnbt.
Só para relembrar os mais esquecidos (origem abstract da ASCO 2010):
Conclusions: The AE37 + GM-CSF vaccine decreases Tregs during and after completion of vaccination while GM-CSF alone does not alter Treg levels. This suggests that AE37 may allow the immune system to more effectively fight cancer and correlates with an observed decrease in recurrences.
Agora a questão que coloco é: Quanto vale o AE37? (deixo a resposta aos especialistas...)
http://finance.yahoo.com/news/Generex-O ... l?x=0&.v=1
Generex Oncology Announces Consultancy of Dr. George E. Peoples, MD.
Dr. Peoples will supervise the on-going Phase II clinical trial of the Company's breast cancer vaccine, provide advice and assistance to the Company in respect of the design and implementation of a Phase III trial of the vaccine, and liaise with the Food and Drug Administration regarding the clinical and regulatory development of the vaccine
Este Dr. George E. Peoples é muito bom e está a trabalhar com a generex.
http://finance.yahoo.com/news/Generex-B ... l?x=0&.v=1
Generex Biotechnology Initiates Social Media Campaign for Its Corporate and e-Commerce Websites
Online Efforts Will Focus on Glucose RapidSpray(TM), Crave-NX(TM) Diet Spray, BaBoom!(TM) Energy Spray and Glucose RapidSpray(TM) for Pets(TM)
A generex ataca através das redes sociais!
http://seekingalpha.com/article/222130- ... urce=yahoo
Generex Oncology Names Dr. Craig Eagle to its Scientific Advisory Board to Assist with its Proprietary Cancer Vaccines Program
Dr. Eagle currently serves as Vice President of Strategic Alliances and Partnerships for the Oncology business unit at Pfizer Inc
:)
Além disso convem não esquecer que a fase III do oral lyn está prestes a terminar! Provavelmente no final do ano a generex vai submeter o produto para aprovação à FDA.
Quanto vale o oral-lyn? (deixo a resposta aos especialistas...)
Interessante também tem sido observar o comportamento da MNKD:
http://finance.yahoo.com/q?s=MNKD
MNKD vs GNBT! Quem vai ganhar o mercado dos diabetes? Quem ganha? o Oral-lyn ou o AFREZZA? (deixo a resposta aos especialistas....). Para Dezembro está marcada da resposta da FDA à MNKD! e , curiosamente, a Seaside 88 está dentro da generex e da MNKD!
Boa semana
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
Pedro,
Sabes alguma coisa sobre a GNBT, disparou á minutos com grandes compras. Não consigo encontrar feeds de noticias... já vai nos 7% e com grandes ordens de compra.
Sabes alguma coisa sobre a GNBT, disparou á minutos com grandes compras. Não consigo encontrar feeds de noticias... já vai nos 7% e com grandes ordens de compra.
AC Investor Blog
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
-
- Mensagens: 4891
- Registado: 8/12/2007 23:01
- Localização: Vila Nova de Gaia
pedro200 Escreveu:Boa abertura...
Boa semana a todos
http://finance.yahoo.com/news/Generex-S ... 5.html?x=0
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
Drecksack Escreveu:Os investidores têm a possibilidade de votar a favor ou contra o reverse-split através de um proxy.
Esta votação é só válido para quem vive na América, ou alguém aqui conseguiu ou recebeu notificação ?
Não recebi nada! Mas também não procurei saber se isso era possível.
Abraço,
Boa semana
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
Algum dos investidores nacionais conseguiu votar no que se refere ao reverse-split ?
http://finance.yahoo.com/news/Generex-I ... l?x=0&.v=1
http://finance.yahoo.com/news/Generex-I ... l?x=0&.v=1
- Mensagens: 980
- Registado: 30/6/2008 20:42
- Localização: 1
- Mensagens: 1072
- Registado: 29/11/2007 4:08
- Localização: Santa Maria da Feira
http://secfilings.nasdaq.com/filingFram ... F2010&pdf=
Dear Stockholder:
You are cordially invited to attend a special meeting of stockholders of Generex Biotechnology Corporation ("Generex") that will be held on Friday, September 17, 2010, at 10:00 a.m. (local time), at the Meeting Rooms, Westin Harbour Castle Hotel, 1 Harbour Square, Toronto, Ontario Canada M5J 1A6, for the following purposes, as set forth in the accompanying Proxy Statement:
1. To approve an amendment to our Restated Certificate of Incorporation (i) to effect a reverse stock split of our common stock, at an exchange ratio of not less than 1-for-2 and not more than 1-for-10 at any time prior to September 16, 2011 (the implementation of the reverse stock split, ratio and timing of which will be subject to the discretion of the Board of Directors), and (ii) following the reverse stock split, if implemented, to reduce the number of authorized shares of common stock from 750,000,000 to 500,000,000 unless the Board of Directors utilizes a ratio of not more than 1-for-2, in which case, the number of authorized shares of common stock will be maintained at 750,000,000;
2. To approve the adjournment of the Generex special meeting, if necessary, to solicit additional proxies for the foregoing proposal; and
3. To conduct any other business as may properly come before the Generex special meeting or any adjournment or postponement thereof.
The Board of Directors has established the close of business on August 17, 2010, as the record date for the determination of stockholders entitled to receive notice of, and to vote at, the special meeting and any adjournment or postponement thereof. This Notice and the Proxy Statement and the attached proxy card are being mailed to stockholders on or about August 23, 2010.
Dear Stockholder:
You are cordially invited to attend a special meeting of stockholders of Generex Biotechnology Corporation ("Generex") that will be held on Friday, September 17, 2010, at 10:00 a.m. (local time), at the Meeting Rooms, Westin Harbour Castle Hotel, 1 Harbour Square, Toronto, Ontario Canada M5J 1A6, for the following purposes, as set forth in the accompanying Proxy Statement:
1. To approve an amendment to our Restated Certificate of Incorporation (i) to effect a reverse stock split of our common stock, at an exchange ratio of not less than 1-for-2 and not more than 1-for-10 at any time prior to September 16, 2011 (the implementation of the reverse stock split, ratio and timing of which will be subject to the discretion of the Board of Directors), and (ii) following the reverse stock split, if implemented, to reduce the number of authorized shares of common stock from 750,000,000 to 500,000,000 unless the Board of Directors utilizes a ratio of not more than 1-for-2, in which case, the number of authorized shares of common stock will be maintained at 750,000,000;
2. To approve the adjournment of the Generex special meeting, if necessary, to solicit additional proxies for the foregoing proposal; and
3. To conduct any other business as may properly come before the Generex special meeting or any adjournment or postponement thereof.
The Board of Directors has established the close of business on August 17, 2010, as the record date for the determination of stockholders entitled to receive notice of, and to vote at, the special meeting and any adjournment or postponement thereof. This Notice and the Proxy Statement and the attached proxy card are being mailed to stockholders on or about August 23, 2010.
- Mensagens: 577
- Registado: 1/9/2009 10:52
- Localização: 7
http://pipelinereview.blogspot.com/
In July, my friend TC and I attended Generex's (GNBT) Annual Meeting of Shareholders. While at the meeting, I had the opportunity to meet Joseph Moscato, the managing partner at Seahawk Capital based in New York City, a consultant of Generex's who has advised them on strategic planning and business development opportunities over the past year and a half. He is also quite a colorful character and we enjoyed talking to him about his consultancy role at the company. Near the end of our trip at Generex's hometown of Toronto, TC and I spoke to Joe about catching up near his NYC office since we both live nearby.
Last week, TC and I made our way to the Capital Grille in downtown NYC to join Joe and to learn about his company. I was mainly interested in gauging Joe's long term sentiment for Generex and to determine if it matched my own. While spending time with Joe, I found it very comforting that he knew in great detail many aspects of the company and that his vision is long term with hopes to help them reach their full potential. I realize that is an easy sentiment for him to portray, but it takes deep due diligence to talk with the depth of knowledge about Oral-lyn and AE37 that we shared while standing near the bar. We appreciated learning that Joe shares in our belief that Generex is headed for great success.
To our surprise, we learned from Joe that Dr. Craig Eagle, Vice President of Strategic Alliances and Partnerships for the Oncology business unit at Pfizer (PFE) and recent addition to Generex's oncology scientific advisory board, would also join us later in the evening for an informal introduction. To be able spend time with a professional involved with guiding small biotechs in their financial and business opportunities, as well as a true pharma expert that leads them on the proper scientific course, is an unique opportunity for a couple of retail shareholders. Many NYC based brokers stood near us at the bar, and we felt like we had a glimpse of life with the movers and shakers. As Joe's Blackberry buzzed all night, TC and I joked that our phones must be broken.
The Eagle Has Landed
I was primed to talk more with Dr. Eagle about Generex's active pipeline of diabetes drugs and cancer vaccines, and when he arrived, I wasted no time. He was a friendly guy with no hint of arrogance, and he was surprisingly open to numerous topics of discussion. Fresh beers in our hands, we were the only guys in a NYC bar talking about peptides the way others talk about the Yankees or Mets. TC and I listened, as Dr. Eagle began by telling us the scientific promise he sees in Generex as a whole. To show how amateurish I am, I placed down a copy of a recent analysis I had written about Antigen Express and their AE37 HER2/neu peptide-based breast cancer vaccine. Later, I noticed Dr. Eagle use the paper as a coaster for his beer.
Dr. Eagle explained why he felt that Generex contains great scientific value in its pipeline; from the the potential for revenue streams from the Rapidmist delivery system, to a positive opinion about prospects for Oral-lyn, to how AE37 could have the potential to completely change how breast cancer is treated. Dr. Eagle's words reminded me of similar sentiment given earlier in the year by one of the original founders of Amgen (AMGN), Dr. Joseph Rubinfeld, who joined Generex in mid-2009 to act as the company's chief scientific advisor. You can read Dr. Rubinfeld's words here where he talks about the vast potential he envisions for the technologies and science of Generex and Antigen Express.
We must have talked to Dr. Eagle for an hour straight, the poor guy, as I delved into Ii-Key hybrids, CD4 T Helper Cells, and other peptide based vaccines such as E75 and GP2. To look cool, I mentioned other vaccine researchers I admire, such as the Mayo Clinic's Keith Knutson and UW's Mary Disis. To be honest, that didn't make me look any cooler. He fluently discussed numerous details of the research I mentioned, as I tried to relate this to Generex's Ii-Key hybrid technology. I believe that he appeared equally passionate. Our discussions led me to feel that there is some sort of pharma interest in AE37, and that this interest was born from the positive interim results from the ongoing multi-center Phase II HER2/neu breast cancer vaccine study being conducted with the United States Military Cancer Institute.
We know that in December 2009, AE37 data as a preventative HER2/neu breast cancer vaccine (see the actual poster here) was presented at the San Antonio Breast Cancer Symposium. Lead researcher from the USMCI, Col George Peoples, reported to the symposium that at a median follow-up of 13 months, there were NO relapses in 49 patients receiving the AE37 vaccine for breast cancer while relapses were observed in 5 of 71 patients in the control group. Col. Peoples also reported data regarding a significant increase in DTH levels which illustrated that AE37 was providing the desired immunological effect, and that there were no serious levels of toxicity reported for any of the subjects receiving AE37. Generex's management has publicly stated that they have begun discussions with pharma companies in light of this data, and I feel this is the reason they signed on Dr. Eagle as a scientific advisor.
Dr. Eagle explained that in his role he helps get them up to snuff on protocols, and offers guidance to them in their next developmental and regulatory steps. His role, among others, is to get them ready for a potential partner to take the risk in partnering with them on, let's say, AE37 for their pending Phase III breast cancer study. He told us, upon questioning, that his obligation is to help them no matter which partner eventually emerges with the right pocket book. As a result of my own due diligence, from analyzing Roche (RHHBY.PK) and Genentech's (DNA) blockbuster breast cancer drug Herceptin, as well as Dendreon's (DNDN) metastatic prostate cancer vaccine Provenge, I feel AE37 as a preventative breast cancer vaccine should currently be valued over $1 billion. Yet, we see that Generex's market cap is currently in the low range of $100 million.
To give a brief on that analysis, consider that while only 25% of breast cancers have levels of HER-2/neu expression high enough to be candidates for treatment with Herceptin, those cancers expressing lower levels are expected to be good candidates for AE37. The advantage of this is that the immune system, once activated, is capable of detecting lower levels of the target protein than is Herceptin and that the anti-tumor activity lasts long after termination of AE37 treatment. And also consider that since AE37 is being developed to prevent cancer recurrence, I hope it will eventually make a vaccine such as Provenge, designed to treat metastatic cancer, one that stays in the back room of the pharmacy. AE37 may lead to longer and healthier lives, while Dendreon's significant advance has been shown to extend the last stage of life by a few precious months. I hope both may prove to be great medical advances that take us beyond this era of Herceptin, and they usher in a new era of immunotherapeutic vaccines that may revolutionize how cancer is treated.
Throwing Peptides As Darts
Throughout our discussion, Dr. Eagle would make an analogy to study data as being like throwing darts. Yes, he knows the seriousness of the disease being researched, but the analogy was to simplify a complex statistical metric to help TC and I understand. He said if one person in the bar throws a dart for a bullseye, that this would not be significant. The amount of times an attempt was made is very important, as well as other factors including the distance to the board. To establish the bulls eye as a trend among a group of people playing darts, it would then be important to know how many are actively involved. I asked if that meant the study has to be powered enough and with a properly defined endpoint. He said yes, and that this is an area that is very important.
I referred to the Phase I results for AE37 in both breast and prostate cancer patients as also being positive. For prostate cancer subjects in the Phase I, results were presented at the 25th Annual EAU Congress this past April. I talked about how out of 32 subjects, 23 patients had positive DTH responses following immunization, and the median progression-free survival for DTH responders was 18 months compared to 1 month for DTH non-responders. (You can see those results here.) He again reminded me of the analogy of throwing darts. I mildly protested that similar DTH responses have been found in AE37's Phase II breast cancer study. I guess I was trying to increase their score!
In reality, Generex and Antigen Express are not playing darts, but appear to be entering a transformative period of development where the goal is commercializing medical advancements that will better peoples lives. A partner for AE37 may or may not be close at hand, but I do feel the vaccine technology of Antigen Express is closer to gaining widespread attention based on all of the promising early results. I sure hope so, because like other Generex shareholders, I'd like the focus to return towards the pipeline and not NASDAQ or a reverse split of our shares.
In my opinion, a pharma could be watching for further AE37 data that is deeper into the Phase II breast cancer study and with a higher amount of patients included in order to make that judgement call. That would mean more darts need to be thrown by AE37 in order to establish the current trend as being significant. In the meantime, Dr. Eagle is helping them get ready. When that data can be made available is not something I can guess, and I've over speculated enough. Dr. Eagle gave no signal about big pharma's current interest in potentially partnering with Generex for AE37. I developed that opinion strictly on my own.
I also know these things can change in a heartbeat, and for the last week I have been conflicted about even writing this blog. However, I feel other shareholders may be interested in our discussions with Dr. Eagle. While speculating is a fool's game, it is hard not to notice that we were not only talking to Generex's scientific advisor, but also Pfizer's Vice President of Strategic Alliances and Partnerships for the Oncology business unit.
In July, my friend TC and I attended Generex's (GNBT) Annual Meeting of Shareholders. While at the meeting, I had the opportunity to meet Joseph Moscato, the managing partner at Seahawk Capital based in New York City, a consultant of Generex's who has advised them on strategic planning and business development opportunities over the past year and a half. He is also quite a colorful character and we enjoyed talking to him about his consultancy role at the company. Near the end of our trip at Generex's hometown of Toronto, TC and I spoke to Joe about catching up near his NYC office since we both live nearby.
Last week, TC and I made our way to the Capital Grille in downtown NYC to join Joe and to learn about his company. I was mainly interested in gauging Joe's long term sentiment for Generex and to determine if it matched my own. While spending time with Joe, I found it very comforting that he knew in great detail many aspects of the company and that his vision is long term with hopes to help them reach their full potential. I realize that is an easy sentiment for him to portray, but it takes deep due diligence to talk with the depth of knowledge about Oral-lyn and AE37 that we shared while standing near the bar. We appreciated learning that Joe shares in our belief that Generex is headed for great success.
To our surprise, we learned from Joe that Dr. Craig Eagle, Vice President of Strategic Alliances and Partnerships for the Oncology business unit at Pfizer (PFE) and recent addition to Generex's oncology scientific advisory board, would also join us later in the evening for an informal introduction. To be able spend time with a professional involved with guiding small biotechs in their financial and business opportunities, as well as a true pharma expert that leads them on the proper scientific course, is an unique opportunity for a couple of retail shareholders. Many NYC based brokers stood near us at the bar, and we felt like we had a glimpse of life with the movers and shakers. As Joe's Blackberry buzzed all night, TC and I joked that our phones must be broken.
The Eagle Has Landed
I was primed to talk more with Dr. Eagle about Generex's active pipeline of diabetes drugs and cancer vaccines, and when he arrived, I wasted no time. He was a friendly guy with no hint of arrogance, and he was surprisingly open to numerous topics of discussion. Fresh beers in our hands, we were the only guys in a NYC bar talking about peptides the way others talk about the Yankees or Mets. TC and I listened, as Dr. Eagle began by telling us the scientific promise he sees in Generex as a whole. To show how amateurish I am, I placed down a copy of a recent analysis I had written about Antigen Express and their AE37 HER2/neu peptide-based breast cancer vaccine. Later, I noticed Dr. Eagle use the paper as a coaster for his beer.
Dr. Eagle explained why he felt that Generex contains great scientific value in its pipeline; from the the potential for revenue streams from the Rapidmist delivery system, to a positive opinion about prospects for Oral-lyn, to how AE37 could have the potential to completely change how breast cancer is treated. Dr. Eagle's words reminded me of similar sentiment given earlier in the year by one of the original founders of Amgen (AMGN), Dr. Joseph Rubinfeld, who joined Generex in mid-2009 to act as the company's chief scientific advisor. You can read Dr. Rubinfeld's words here where he talks about the vast potential he envisions for the technologies and science of Generex and Antigen Express.
We must have talked to Dr. Eagle for an hour straight, the poor guy, as I delved into Ii-Key hybrids, CD4 T Helper Cells, and other peptide based vaccines such as E75 and GP2. To look cool, I mentioned other vaccine researchers I admire, such as the Mayo Clinic's Keith Knutson and UW's Mary Disis. To be honest, that didn't make me look any cooler. He fluently discussed numerous details of the research I mentioned, as I tried to relate this to Generex's Ii-Key hybrid technology. I believe that he appeared equally passionate. Our discussions led me to feel that there is some sort of pharma interest in AE37, and that this interest was born from the positive interim results from the ongoing multi-center Phase II HER2/neu breast cancer vaccine study being conducted with the United States Military Cancer Institute.
We know that in December 2009, AE37 data as a preventative HER2/neu breast cancer vaccine (see the actual poster here) was presented at the San Antonio Breast Cancer Symposium. Lead researcher from the USMCI, Col George Peoples, reported to the symposium that at a median follow-up of 13 months, there were NO relapses in 49 patients receiving the AE37 vaccine for breast cancer while relapses were observed in 5 of 71 patients in the control group. Col. Peoples also reported data regarding a significant increase in DTH levels which illustrated that AE37 was providing the desired immunological effect, and that there were no serious levels of toxicity reported for any of the subjects receiving AE37. Generex's management has publicly stated that they have begun discussions with pharma companies in light of this data, and I feel this is the reason they signed on Dr. Eagle as a scientific advisor.
Dr. Eagle explained that in his role he helps get them up to snuff on protocols, and offers guidance to them in their next developmental and regulatory steps. His role, among others, is to get them ready for a potential partner to take the risk in partnering with them on, let's say, AE37 for their pending Phase III breast cancer study. He told us, upon questioning, that his obligation is to help them no matter which partner eventually emerges with the right pocket book. As a result of my own due diligence, from analyzing Roche (RHHBY.PK) and Genentech's (DNA) blockbuster breast cancer drug Herceptin, as well as Dendreon's (DNDN) metastatic prostate cancer vaccine Provenge, I feel AE37 as a preventative breast cancer vaccine should currently be valued over $1 billion. Yet, we see that Generex's market cap is currently in the low range of $100 million.
To give a brief on that analysis, consider that while only 25% of breast cancers have levels of HER-2/neu expression high enough to be candidates for treatment with Herceptin, those cancers expressing lower levels are expected to be good candidates for AE37. The advantage of this is that the immune system, once activated, is capable of detecting lower levels of the target protein than is Herceptin and that the anti-tumor activity lasts long after termination of AE37 treatment. And also consider that since AE37 is being developed to prevent cancer recurrence, I hope it will eventually make a vaccine such as Provenge, designed to treat metastatic cancer, one that stays in the back room of the pharmacy. AE37 may lead to longer and healthier lives, while Dendreon's significant advance has been shown to extend the last stage of life by a few precious months. I hope both may prove to be great medical advances that take us beyond this era of Herceptin, and they usher in a new era of immunotherapeutic vaccines that may revolutionize how cancer is treated.
Throwing Peptides As Darts
Throughout our discussion, Dr. Eagle would make an analogy to study data as being like throwing darts. Yes, he knows the seriousness of the disease being researched, but the analogy was to simplify a complex statistical metric to help TC and I understand. He said if one person in the bar throws a dart for a bullseye, that this would not be significant. The amount of times an attempt was made is very important, as well as other factors including the distance to the board. To establish the bulls eye as a trend among a group of people playing darts, it would then be important to know how many are actively involved. I asked if that meant the study has to be powered enough and with a properly defined endpoint. He said yes, and that this is an area that is very important.
I referred to the Phase I results for AE37 in both breast and prostate cancer patients as also being positive. For prostate cancer subjects in the Phase I, results were presented at the 25th Annual EAU Congress this past April. I talked about how out of 32 subjects, 23 patients had positive DTH responses following immunization, and the median progression-free survival for DTH responders was 18 months compared to 1 month for DTH non-responders. (You can see those results here.) He again reminded me of the analogy of throwing darts. I mildly protested that similar DTH responses have been found in AE37's Phase II breast cancer study. I guess I was trying to increase their score!
In reality, Generex and Antigen Express are not playing darts, but appear to be entering a transformative period of development where the goal is commercializing medical advancements that will better peoples lives. A partner for AE37 may or may not be close at hand, but I do feel the vaccine technology of Antigen Express is closer to gaining widespread attention based on all of the promising early results. I sure hope so, because like other Generex shareholders, I'd like the focus to return towards the pipeline and not NASDAQ or a reverse split of our shares.
In my opinion, a pharma could be watching for further AE37 data that is deeper into the Phase II breast cancer study and with a higher amount of patients included in order to make that judgement call. That would mean more darts need to be thrown by AE37 in order to establish the current trend as being significant. In the meantime, Dr. Eagle is helping them get ready. When that data can be made available is not something I can guess, and I've over speculated enough. Dr. Eagle gave no signal about big pharma's current interest in potentially partnering with Generex for AE37. I developed that opinion strictly on my own.
I also know these things can change in a heartbeat, and for the last week I have been conflicted about even writing this blog. However, I feel other shareholders may be interested in our discussions with Dr. Eagle. While speculating is a fool's game, it is hard not to notice that we were not only talking to Generex's scientific advisor, but also Pfizer's Vice President of Strategic Alliances and Partnerships for the Oncology business unit.
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Boas,
Não poderá haver haver nesta acção um Buy on the rumor and sell on the news?
Aliás, esta acção é notável pelas suas tiradas, e já teve como outras como as de hoje..
No entanto, o rátio risco/lucro é deveras tentador.
Mas acho que é isso mesmo que cria estas subidas e não a quase certeza que o tal medicamento vai ser aprovado.
Cumps
Uly
Não poderá haver haver nesta acção um Buy on the rumor and sell on the news?
Aliás, esta acção é notável pelas suas tiradas, e já teve como outras como as de hoje..
No entanto, o rátio risco/lucro é deveras tentador.
Mas acho que é isso mesmo que cria estas subidas e não a quase certeza que o tal medicamento vai ser aprovado.
Cumps
Uly
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AC Investor Blog Escreveu:pedro200 Escreveu:Boa noite,
se a MM200 for quebrada com sucesso, quais as resistências mais significativas a seguir?
Obrigado
$.60
Obrigado pela rapidez!
estive a acompanhar o fecho...
não esqueçer que o dia 31 de Agosto está a chegar...:
"On July 9, 2010, Generex Biotechnology Corporation (the "Company") received written notice that a Nasdaq Hearings Panel (the "Panel") had determined to grant the request of the Company to remain listed on The Nasdaq Stock Market, subject to certain conditions. These conditions include: (1) the Company informing the Panel on or about July 28, 2010 that it has obtained shareholder approval to implement a reverse stock split in a ratio sufficient to meet the $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2); and (2) the Company informing the Panel on or about August 31, 2010 whether it has a signed term sheet in respect of a material business opportunity (a "Business Opportunity"). If the Company does not have a signed term sheet for a Business Opportunity as of August 31st, the Company must implement the reverse stock split and demonstrate a closing bid price for its common stock of $1.00 per share or more for a minimum of ten consecutive trading days on or before September 30, 2010 to regain compliance with Nasdaq's bid price requirement and avoid delisting. If the Company does have a signed term sheet for a Business Opportunity by August 31st, the Company must provide the Panel with an update on its stock price and trend, recent public disclosures, and a timeline for either signing and announcing an agreement relating to a Business Opportunity or, alternatively, implementing a reverse stock split, along with other factors for the Panel to consider in determining whether and for how long to continue the Company's listing; upon the Company's submission of such information, the Panel will then evaluate the Company's request for continued listing through October 2010"
Atenção às palavras: on or aboutAugust 31
Cumprimentos
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pedro200 Escreveu:Boa noite,
se a MM200 for quebrada com sucesso, quais as resistências mais significativas a seguir?
Obrigado
$.60
AC Investor Blog
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Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
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Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
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nk667 Escreveu:Ola Ulisses, peço desculpa por esse post.
Digo isso porque ela esta a subir 10% e com bastante volume sem ter saido nenhuma noticia (pode haver sempre fuga de informaçao), e porque a Generex costuma dar noticias a terça feira.
Abraço e bons negocios
Lá isso é verdade! a Generex custuma divulgar noticias à terça-feira.
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AC Investor Blog Escreveu:O interesse pelo titulo volta aumentar e de forma acentuada, temos já um novo máximo dos últimos dois meses e com uma lqiuidez acima do normal. Próximo alvo $.487
Boa noite,
se a MM200 for quebrada com sucesso, quais as resistências mais significativas a seguir?
Obrigado
- Mensagens: 577
- Registado: 1/9/2009 10:52
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Ola Ulisses, peço desculpa por esse post.
Digo isso porque ela esta a subir 10% e com bastante volume sem ter saido nenhuma noticia (pode haver sempre fuga de informaçao), e porque a Generex costuma dar noticias a terça feira.
Abraço e bons negocios
Digo isso porque ela esta a subir 10% e com bastante volume sem ter saido nenhuma noticia (pode haver sempre fuga de informaçao), e porque a Generex costuma dar noticias a terça feira.
Abraço e bons negocios
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O interesse pelo titulo volta aumentar e de forma acentuada, temos já um novo máximo dos últimos dois meses e com uma lqiuidez acima do normal. Próximo alvo $.487
AC Investor Blog
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
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Para quem vem seguindo esta menina deixo-vos aqui o gráfico com alguns riscos 
mas a análise completa está no sitio do costume, só que em Inglês 
A Tendência virou....
mas a análise completa está no sitio do costume, só que em Inglês
A Tendência virou....
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AC Investor Blog
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Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
www.ac-investor.blogspot.com -
Análises Técnicas de activos cotados em Wall Street. Os artigos do AC Investor podem também ser encontrados diariamente nos portais financeiros, Daily Markets, Benzinga, Minyanville, Solar Feeds e Wall Street Pit, sendo editor e contribuidor. Segue-me também no Twitter : http://twitter.com/#!/ACInvestorBlog e subscreve a minha newsletter.
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