CEL-SCI : un peu "plus" de lecture ...

FoscoS

09 février 2012 •10:05

L'analyse de Ray Dirks est enthousiaste certes mais...

... lire les "disclosure" : Cel SCI a payé $ 4000 à Ray Dirks pour des conseils et le "coverage" de l'action ...

... cependant Ray Dirks est un analyste respecté et connu sur la place et intègre. Ce qui l'a fait connaître : il avait notamment dénoncé un scandale financier dans les années 70.

SIMlS

09 février 2012 •13:34

With the dust settling following last month’s financing deal in which CEL-SCI Corporation (AMEX: CVM) sold 16,000,000 shares of its common stock to institutional investors for $5,760,000 or $0.36 per share, along with those institutional investors receiving Series H warrants which entitle the investors to purchase up to 12,000,000 shares of CEL-SCI’s common stock which can be exercised at any time after July 31, 2012 and on or prior to July 31, 2015 at a price of $0.50 per share it appears as if investors are once again ready to start betting on the small biotech firm.
On Monday trading volume topped the 10.2 million mark as shares climbed a s high as 0.42 and on Tuesday CVM has once again showed strong volume, surpassing the 5.5 million mark in early-afternoon trading while shares have climbed as high as 0.47, inching closer to their six-month high of 0.49.
While it has been a long, and often times troubling, road for CVM the company is hoping that they are nearing the finish line as their Phase III trial for Multikine, being developed as a potential first-line treatment for advanced primary head and neck cancer, moves forward. Peaking investor interest is the fact that Multikine could become a standard-of-care immunotherapeutic treatment for head and neck cancers, a devastating diagnosis that often results in death in a short period of time.
CVM’s goal with Multikine can be summarized in the comments made by the company in their letter to shareholders back on January 20, 2012 in which it was stated “Our vision for Multikine has always been that, by activating the immune response against the cancer, it could be a useful addition to the current treatment options used by cancer patients and doctors – and that it should add little to no toxicity to the existing treatments being used. With this vision in mind we selected head and neck cancer, a hard to treat and devastating disease, as a first target for Multikine. Head and neck cancer represents a clear unmet medical need, and there is currently one standard of care for its treatment worldwide. By adding Multikine to the current standard of care we hope to improve the overall survival currently achievable in these patients. As little to no progress has been achieved in these patients in almost 50 years, this would be seen as a major achievement.”
With no significant revenue generated to date CVM has essentially placed all their eggs in this basket but that doesn’t mean that’s a bad bet. They have established some strong partnerships along the way, most notably with Teva Pharmaceuticals which recently increased its involvement in Multikine’s advancement by assisting in adding new hospital locations for the Phase III trial while also expanding their licensing deal with CVM last fall to add Croatia and Serbia to their list of countries included in their exclusive license, the other two being Israel and Turkey.
Teva’s further involvement has led to a boost in investor confidence as Teva has a long history in the field of oncology and if they see promise in Multikine as a treatment to shrink, and possibly even eliminate, head and neck cancer tumors then there may be hope for FDA approval down the road. It should be noted that Multikine is an immune-therapy, essentially designed to stimulate a patient’s immune-system back on and target tumors. CVM has already received FDA approval for their certified cold-fill manufacturing facility, where the universal formulation that is Multikine is manufactured.
All of this being said, the bottom line is CVM still needs to gain FDA approval for Multikine and it is the company’s belief that “If we are successful in proving that the addition of Multikine to the current cancer therapies increases the patients’ overall survival, we would then expect to submit the Multikine drug dossier to regulatory agencies around the world for approval.” This could still be some time off, something that long-time shareholders have grown to accept. CVM’s advancement of Multikine has been years in the making and it could be years before approval ever comes.
There have been a number of positive indicators that suggest Multikine is proving itself as a legitimate treatment for an unmet need but the FDA doesn’t just hand out approvals, it’s a long process. Unfortunately for CVM they haven’t always been on the FDA’s good side; back in August the company received and responded to a Warning Letter issued to the Company by the Division of Drug Advertising Marketing and Compliance (DDMAC) U.S. Food and Drug Administration (FDA) regarding certain statements made about their investigational therapy Multikine on their corporate website. That Warning Letter identified “specific statements on various pages of the CEL-SCI website as promoting this investigational therapy as safe and effective for the purposes for which it is being investigated.” This isn’t to say that the FDA will hold a grudge against CVM but it may mean they look at the company’s Phase III trial a bit closer.
Judging by the actions of Teva and their expanded position with Multikine the idea of investing in CVM is certainly attractive. While the focus right now is on Multikine CVM is also “developing (and investigating) an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu.”
Up to this point the popular practice among many investors has been to buy on the dips and sell on the highs but eventually there will come a point when the dips and highs will be much further apart. What long-term investors have to determine is if the current share price is worth the bet that CVM will be capable of introducing a new treatment to a market that is wide open.

http://www.otcequity.com/?p=1774

FoscoS

09 février 2012 •22:25

http://finance.yahoo.com/news/CEL-SCI-Corporation-Reports-bw-801569675.html?x=0