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Dog House
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Biovest International, Inc.
(Public, OTC:BVTI.OB) As individuals in our respective societies, we all abide by a certain moral standing. However, regardless of your lifestyle, you will adhere to the notion that there is no greater feeling in the world than knowing you are helping fund a company which could potentially save millions of lives, while at the same time fulfilling your needs through growing your pockets as well. So without further ado, let’s all welcome Biovest International, Inc. (OTC:BVTI) as StocksHaven Investment’s newest company profile. Recently the company has stricken interest from the investment community through its product, BiovaxID, which has seen very positive Phase III results presented at Asco Plenary Session. BiovaxID is truly revolutionary, the cancer vaccine evokes the power of each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. Before beginning the analysis, lets also keep in mind that with the phase III were presented nearly four months ago on 05/31/09, meaning an NDA announcement could come at anytime. Biovest’s President, Samuel Duffey states, ““We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways.” About Biovest International Inc. Biovest International, Inc. (Biovest) is a biotechnology company focusing primarily on the development of BiovaxID, a patient-specific, anti-cancer vaccine focusing on the treatment of follicular non-Hodgkins lymphoma, or follicular NHL. BiovaxID is a customized anti-cancer vaccine that is derived from a patient’s own cancer cells and is designed to utilize the power of the patient’s immune system to recognize and destroy cancerous lymphoma cells, while sparing normal cells. The Company produces this vaccine by extracting some of the patient’s tumor cells and then replicating and purifying the antigen that is present only on the surface of the patient’s own tumor cells. Biovest is conducting a pivotal Phase 3 clinical trial for BiovaxID in patients with the indolent, or low-grade, form of B-cell follicular NHL. Products BiovaxID Cancer Vaccine The Biovest cancer immunotherapy stems from work begun in 1986 on development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. In the vaccine’s cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in non-cancerous tissue. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces a powerful immune response against the cancerous cells that in many cases results in pronounced, complete cancer clearance. Because each dose of Biovest’s vaccine is derived from individual patient’s cancerous cells, the vaccine is a true targeted, customized therapy. The vaccine’s powerful anti-tumor effect vastly exceeds that of non-targeted traditional therapy, as it arises from the immune system’s defense cells’ innate ability to selectively target foreign antigens. Most importantly, the immune response triggered by the vaccine against the cancerous tissue is a natural disease-fighting mechanism and has almost none of the side-effects associated with the broad-spectrum chemotherapy and radiation used to traditionally treat this type of lymphoma. BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor, and selectively targets only the cancerous B-cells, while sparing healthy cells. BiovaxID is highly specific in its anti-lymphoma attack because the vaccine “trains” the body’s own immune system to recognize as foreign the unique protein (idiotype) expressed only on the cancerous B-cells, thus stimulating and recruiting the patient’s own immune system to destroy the cancer cells and potentially prevent recurrence. In contrast, other existing chemotherapeutic and monoclonal antibody therapies destroy most of the healthy B-cells in addition to the cancerous cells, and may result in serious adverse side-effects. Because the BiovaxID vaccine is comprised of the patient’s own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated. Futhermore, as the leading manufacturer of hollow fiber technology and with over 2 decades of cell culture experience, Biovest has pioneered a unique platform to commercialize patient-specific biologics. What makes this vaccine truly unique is the fact that made from each patient, for each patient using the AutovaxID. BiovaxID utilzes a patient specific process to create tailor-made therapeutic cancer vaccines ![]() About Non-Hodgkin’s Lymphoma & Target Market The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2 billion in 2013 from the current size of $2.2 billion. There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy. Related B-cell derived neoplasms include multiple myeloma (approx. 15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in the US). Positive Critical Phase III Trials Biovest International, Inc. announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase III clinical study has shown that BiovaxID® (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study, which was featured at the American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47 percent. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the first ever vaccine targeting lymphoma to demonstrate such a disease-free survival benefit. A previous Phase II study demonstrated that patients receiving the BiovaxID vaccine developed a highly-specific immune response against tumor cells, with 95 percent of patients showing significant T-cell activity against their lymphoma and 75 percent of patients showing a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent of patients remained in continuous first complete remission with a median disease-free survival of 8 years. The completed Phase III study achieved its primary endpoint of prolonging disease-free survival in patients who were vaccinated with at least one injection of BiovaxID as compared to patients who received control. In the study, 177 patients with follicular lymphoma who had achieved a complete response to PACE (prednisone, doxorubicin, cyclophosphamide and etoposide) chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to the control study arm (KLH/GM-CSF). As prospectively identified, investigators analyzed the cohort of 117 randomized patients who, as required by the study protocol, maintained a complete response to chemotherapy for at least six months and who received active (N=76) or control (N=41) vaccine. After a median follow-up of 4.71 years (56.6 months, range: 12.6 – 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045). FDA Update In addressing regulatory and commercial plans for BiovaxID, Biovest’s President and General Counsel, Samuel Duffey, commented, “We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways. In addition, we plan to make BiovaxID available throughout most of Europe on a named-patient basis. This compassionate-use drug access program allows European physicians to prescribe drugs to qualifying patients before approvals are granted, assuming the protocols for each participating country are followed.” Biovest also reported that the Company expects to publish the final comprehensive results in a peer-reviewed scientific publication later this year (Q4 of 2009). Mentor Capital Cancer Immunotherapy Index The inclusion of BVTI on the Mentor Capital Immunotherapy Index is a tremendous step for this company on several fronts. First of all, it was named one of the top 10 under $10 companies that is involved in cancer treatments which are considered ground-breaking. Among the companies on that list include DNDN, Celldex, and Oncothyreon, to name a few. All of these companies have either reached great end points in their respective critical phase trials, or have great potential. BVTI is one that has yet to reach its potential. To project the estimated price per share, one needs to look no further than the other companies on the list that have reached their potential. DNDN $23 price per share, Celldex $6 price per share, Onco $5 price per share, are the three that have so far blossomed the most. With a similar, yet more advanced treatment study having been completed and implemented in Europe, one would think BVTI can do a similar run-up, once they file an NDA with the FDA. The second major point is the funding that is available to them through this arrangement with Mentor Capital. Perhaps the sole reason for the company’s low price per share has been the fact that their parent company is in chapter 11. Finally, and possible the most surprising and most exciting part is the market cap of 50 million dollars, which may not stand for much longer. Thirteen years of testing and research went into this treatment (phase III lasted 8 years). Does anyone else see DNDN before them? The use of this treatment in Europe on a named patient basis is getting noticed and provides even more results, not to mention gives the company a face. Technical Chart Analysis (pull out 6 months) These past six months have seen impressive gains in both volume and price for BVTI, as it appears to be gaining momentum for another healthy increase in share price. There are strong bullish signals such as the daily 100 SMA (Orange line) currently running above the daily 200 SMA (Yellow line) and both moving averages are on the rise. Also, the year-to-date price action has established an upward trending price channel shown in Blue on the chart. The channel’s definition was actually expanded back in June when the price gained over 1200% in just one month and the volume increased over 10,000%. This movement revealed the current channels the price has been moving within, but also indicates the overall channel is actually much taller. The top of the conservative price channel is currently at $1.03. Today the price bounced off the bottom trend-line, closed right at the ¼ trend-line of the Blue channel, and showed there is pressure to go higher. Once the price exceeds the mid-line (dashed Blue line) currently around .67 cents, the price should easily find the top trend-line of the price channel. With the current increase in volume this month reaching over 20,000% so far, it’s good to keep in the back of your mind that the last time the price made it to the top of the channel it reached $1.50 and that’s over a 200% gain from today’s close. Overall Sentiment Now, we perceive BVTI to be somewhat of an iceberg. It is easy to see the tip, however the true size of it can’t be seen by the naked eye, or average daily investor without conducting some thorough due diligence. Spend a couple of minutes researching and you will notice the 52wk high of $1.50, the fact that it is an extremely successful phase III cancer drug with a billion dollar market potential, and a top 10 under $10 nominee, though one key aspect is missing: the CEO, Francis O’Donnell’s importance. Not many realize he is also the Chairman of BioDelivery Sciences — Yes, that same company who gained FDA approval for its cancer pain drug patch, Onsolis. An experienced CEO who is well acquainted with what it takes to attain FDA approval, positive Phase III completed four months ago, being a part of one of the most prestigious cancer biotech indexes worldwide, and a 52wk high of$1.50 — We shouldn’t even have to state how undervalued Biovest International Inc. truly is. Biovest Inches Closer to NDA Filing (OTC:BVTI) | Last edited by Miles; 09-22-2009 at 05:42 PM.. |
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1 thumbs up / 2 thumbs down.
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VIP Trader
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Picked up some for this pump and dump!
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Junior Trader
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stockhaven. you are pump and dump. scamer
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VIP Trader
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Yes they are....but they have some DD and interviews/PRs to fuel the pump and dump...so I must give them credit for that! They are not just a spammer company!
Dont hate...just learn to use it to make money. When he pumps, get in and sell before the dump starts...then cycle! Nothing wrong with making money! |
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Senior Trader
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Senior Trader
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it's OK to make money off a pump & dump people
![]() i.e. GFGU *cough* *cough* .... poor Siforus is still in it I think
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follow me. . . . http://twitter.com/BullishBEAR (for stock talk) |
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VIP Trader
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I think stockshaven is really a mixed blessing.... he posts buy recommendations on companies most of us have never heard of... In fact I will say that I myself have profited from some of his suggestions... but of course I research those companies heavily on my own... as everyone should.
The part that concerns me is that I believe he should post a complete disclaimer along with any posts on stockrants... as he discloses on his website that he provides investor relations services for certain companies. Which is a much further conflict of interest than most would expect from someone posting on this site. Perhaps this would encourage people to scrutinize these picks more. However at the same time we would be setting precedence for allowing a poster, who some would perceive as a paid pumper. StocksHaven Investments Investor Relations Contracting | Also from the disclaimer on his site: Disclaimer | StocksHaven Investments has been retained to provide investor relations services for some of the companies profiled in this Website and receives compensation for those services. Further, StocksHaven Investments and its employees and affiliates may own, or may purchase and sell, securities of the companies profiled. StocksHaven Investments undertakes no obligation to inform readers about the ownership or trading activities of it or its employees or affiliates in the securities of the profiled companies. All of that being said I don't think anybody should thumbs down his post just because of this, as it does not make anything he said untrue. It also does not make him scamer, even if he was paid to pump.
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Everything I post is merely my opinion... Please perform your own research. I take Absolutely NO responsibility for any actions that you take as a result of my posts. Please be aware that there ARE probably factual errors in my posts and any advice I give is probably BAD advice. If I'm posting about a stock/financial strategy, I must have some sort of a financial interest in it... I am most likely either long /short/looking to buy cheap/sell high and thus an extreme conflict of interest definitely exists. Last edited by dorkytom; 09-22-2009 at 07:37 PM.. |
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VIP Trader
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Nice job....yes...as you can read...he is basically a paid pumper...but he does a damn good job at it. He tells you why and provides some DD for you...at the end you are making the buy. Always make sure you have a stop loss not too far away on a run up! Do not get in late on the pump and dump! Get in ASAP with only 10-20% of your cash and get ready to jump out 20-50% later! Do not get greddy with pump and dump stocks unless you are long and believe in the company! I get a lot of emails from a lot of Google groups and pumper sites....and I can tell you StocksHaven does a great job! A lot of the google groups are just trying to screw you...sites like this do an amazing job as you will find educated and experienced investors providing input and some direction! Anyways...BVTI can be a dream come true and could easily go to $5+ with the cancer drug they have...if approved. It could be a DNDN. If you can hold for NDA to be filled by the company, you will find this stock at $2 probably or more...but for now...it should be around $1 with increased volume everyday! |
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Dog House
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Just a quick update
AVVH is the first company I have received a contract with or any compensation from, as you will see my disclaimers at the end of each post. The contract was announced to the public. Hope this clears any conflict of interest. -SH |
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Stockshaven thanks for clearing that up!!! Thumbs up!!!
I do understand that your site has disclaimers at the bottom for each post, but that requires that I click your link at the bottom then scroll to the bottom of that post. Just a suggestion it would be helpful to have included that within the forum posts or in your signature for this forum...
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Everything I post is merely my opinion... Please perform your own research. I take Absolutely NO responsibility for any actions that you take as a result of my posts. Please be aware that there ARE probably factual errors in my posts and any advice I give is probably BAD advice. If I'm posting about a stock/financial strategy, I must have some sort of a financial interest in it... I am most likely either long /short/looking to buy cheap/sell high and thus an extreme conflict of interest definitely exists. |
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