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Steadfast Holdings Group, Inc. (Pink Sheets: STHG) (April 17, 2008, 7:00am ET) Steadfast Holdings Group, Inc. announced that its Steadfast Automotive stores have begun selling a proprietary spray-on formulation of UV-protectant for all types of truck bed liners, that the Company is branding "Steadfast Rejuvenator." The protectant blocks ultra violet rays which cause bed liners to fade and crack.
John Calash, CEO of Steadfast Holdings Group, Inc., stated, "We know from our sales experience with our commercial and consumer customers that they need a superior spray UV-protectant product to extend the life of their truck's bed liners. Consequently, we had formulated exclusively for us a unique, high performance spray UV-protectant which we are marketing through our stores, and eventually through other accessory stores as well.
We believe Steadfast Rejuvenator is unsurpassed by any comparable product in the market in performance and value for the price. It is yet but one more example of how we are approaching our growth innovatively with high margin product, in order to build incremental revenue and profit."
About Steadfast Holdings Group, Inc.
Steadfast Holdings Group distributes a variety of products to the automotive aftermarket. The core business is its spray on truck bed protection product which offers specially formulated polymers that permanently bond to the truck's bed. The Company's spray-on Polyurea is a remarkable technology with a range of uses limited only by your imagination. They are also utilized in commercial, industrial, agricultural, military and custom applications when this tough coating is used to protect everything from metals to concrete against chemicals, solvents, fuel, etc. The Company is a licensed dealer for the following aftermarket products: A.R.E. Truck Caps and Lids, Tool Boxes, Nerf Bars, Tube Steps, Running Boards, Rack Systems, Rail Caps, Tonneau Covers, Fender Flares, Grilles, Visors, Bug Shields, Roll-Up Covers, Side Rails, Mud Guards, Floor Mats, Lights, Trailer Hitches, Stainless Steel Accessories and Lift Kits. Steadfast also has distribution agreements with the several companies that manufacture light truck aftermarket products. Additional information may be found at www.steadfastlinings.com.
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Calypte Biomedical Corporation (OTCBB: CBMC) Calypte Biomedical Corporation, a developer, manufacturer and marketer of HIV diagnostic tests, announced that its Chinese subsidiary, Beijing Marr Bio-Pharmaceutical Co. Ltd. ("Beijing Marr"), has received registration and marketing approval for Calypte's Aware HIV-1/2 OMT (oral fluid) rapid test from the State Food and Drug Administration ("SFDA") of China. This approval makes the Aware HIV-1/2 OMT test the first and only SFDA approved rapid oral fluid HIV test in China.
Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "This is a major accomplishment for Calypte and we are thrilled to have received this long awaited approval which permits us to begin actively marketing our rapid diagnostic tests in China, one of the potentially largest HIV testing markets in the world. With the medical devices manufacturing permit received earlier this year, our Beijing Marr subsidiary is now able to manufacture, market, distribute and sell the Aware HIV-1/2 OMT test throughout the Peoples' Republic of China. China is committed to aggressively tackle the spread of its HIV epidemic and we believe that our Aware HIV-1/2 OMT (oral fluid) test can and will make a significant contribution to that effort. We appreciate the patience of those investors who have supported us through the long SFDA approval process, particularly our joint venture partners, the Marr Group." Mr. Gale added, "This approval also gives us, for the first time, a very valuable approval in the country of manufacture. Absence of this approval in the past has hampered our ability to register and market the test in a number of countries, a hurdle we can now overcome by producing the domestically approved Aware product in our Chinese factory. With this SFDA approval, we are now in a position to market and sell in countries representing a total population of nearly 3.7 billion, or over half of the worlds' population."
Dr. Ronald Mink, Chief Science Officer for Calypte, remarked, "This approval has validated our perseverance in pursuing the registration of a product in which we have long had confidence. The transformation of the SFDA over the past two to three years into a first tier agency matching the rigor and integrity of its U.S. and European counterparts resulted in a very thorough review of the Aware HIV-1/2 OMT (oral fluid) test. We believe that the Chinese authorities are now comfortable with this new technology, which expands the scope of testing platforms currently available in China.
The SFDA's restructuring has resulted in a review process and timetable that is similar to what we see in the U.S. FDA. We believe these changes will benefit not only China, by setting a higher standard for new medical products, but will also benefit us, by setting a higher barrier to market entry for would-be competitors. Throughout the entire review process, we received continually positive feedback from the SFDA and we have been confident that our technology is solid and our registration would prevail."
David Harris, Beijing Marr's Chief Executive Officer, stated, "This is a very exciting moment for those of us at Beijing Marr who have worked very hard to gain this approval and ready the factory for manufacture, sale and distribution of the Aware HIV-1/2 OMT test. We have already received numerous inquiries from HIV program managers and scientists eager to use the product here in China. We now plan to ramp up our production capacity as we build our distribution network to fully realize the market potential of the Aware HIV-1/2 OMT test in China. Beijing Marr is committed to, and enthusiastic about, bringing this exciting new technology to the Chinese medical community."
Calypte operates in China through Beijing Marr, a joint venture between Calypte and the Marr Group established to manufacture Calypte's Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for both the Chinese and international markets. Beijing Marr operates an ISO 13485:2003 certified manufacturing facility on the outskirts of Beijing. The Aware HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.
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Biovest International, Inc. (OTCBB: BVTI) (Thu, April 17, 2008, 8:00am ET) Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), announced that a key milestone has been achieved in the Company's mission to gain approval for BiovaxID , its personalized anti-cancer vaccine, in a pivotal Phase 3 Fast-Tracked clinical trial for the treatment of indolent follicular non-Hodgkin's lymphoma.
Biovest reported that the independent Data Monitoring Committee (DMC), which is vested with the responsibility of monitoring the safety and efficacy of the BiovaxID trial, has completed a closed session review of the unblinded results, including the primary and secondary endpoints analysis of the Phase 3 study. Based on their analysis, the DMC has recommended that the results be unblinded, and has volunteered to participate, if needed, in Biovest's ongoing regulatory meetings with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory agencies (Health Authorities) in order to determine the most appropriate process for unblinding the results, and establishing a pathway to seek marketing approvals.
The Chairman of the DMC, Dr. Gerald Messerschmidt, reported, "Our Committee has completed a closed session unblinded review of the interim Phase 3 safety and efficacy analyses regarding the BiovaxID registration study. Based on this review, the DMC recommends that the BiovaxID study be unblinded to the Company for final analysis. We further suggest that the final clinical study report include data, as part of Biovest's overall regulatory strategy of submission to the regulatory authorities, through August 29, 2008, which is the date when the last randomized and vaccinated patient reaches 12-months follow-up from first injection. While the DMC cannot release information on our closed session discussions, our recommendation to unblind this pivotal registration study in late-August is based on the status of the study, the defined safety profile over 8-years of this Phase 3 registration study and our review of the primary and secondary endpoint analyses. As part of the ongoing regulatory process, I as a representative of the DMC will relate our review of the closed session analysis of these interim data to Health Authorities as necessary."
Responding to the DMC's recommendations, Biovest's Chairman and CEO, Dr. Steven Arikian, stated, "The DMC's diligent review has resulted in an excellent outcome for BiovaxID. Not only has the Committee reconfirmed the favorable safety profile for BiovaxID, but as importantly, we believe their recommendation to unblind and their willingness to meet with the regulatory authorities to discuss their findings suggests a successful trial outcome. In light of the DMC's recommendation, we have already been in discussions with regulatory agencies, including the FDA, to seek consensus on the appropriate process for unblinding the results and establishing a pathway for potential accelerated and/or conditional approvals for BiovaxID. We also are coordinating with the EMEA regarding potential market access in Europe. If approved, Biovest will have distinguished itself as the first company to have its anti-cancer vaccine reach market in the U.S. or EU, a Herculean achievement. As this study was initiated in 2000, we now have the largest longitudinal database of lymphoma patients receiving a personalized therapeutic vaccine. 234 patients were enrolled and 177 randomized in the Phase 3 trial of which, two-thirds received BiovaxID therapy, and one-third control treatment. We believe that these long-term and highly anticipated results will demonstrate that BiovaxID is capable of prolonging the period of disease-free survival for an incurable form of non-Hodgkin's lymphoma, and in some cases, perhaps even inducing indefinitely prolonged, durable remissions."
As previously presented to the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), the National Cancer Institute (NCI) demonstrated in a Phase 2 clinical trial that patients treated with BiovaxID achieved: a median disease-free survival of over eight years; a 95% overall survival rate after 9.2 years of follow-up; and a 95% cellular immune response. In this clinical trial, 73% of evaluable patients were converted into molecular remission (bcl-2 negative), evidence that their blood has been cleared of residual cancerous cells. BiovaxID also demonstrated an outstanding safety profile.
According to Dr. Angelos M. Stergiou, Biovest's Vice President, Product Development, Medical Affairs & Clinical Research, "This Phase 2 data, combined with our analysis of the blinded Phase 3 results, and the DMC's recommendation to unblind, gives us a high level of confidence in unblinding the current Phase 3 study, both for efficacy and safety. If the results are highly positive, and assuming we are granted accelerated approval for BiovaxID, we would anticipate initiating a Phase 4, post-approval, clinical study for the purpose of collecting further efficacy and safety data."
The primary end-point of the trial is a comparison between treatment groups, those that receive BiovaxID and those that receive a control. The study is looking at duration of disease-free survival measured from the time of randomization (i.e. when a subject is randomly assigned to receive BiovaxID or control) to the time of confirmed relapse.
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Western Standard Energy Corp. (OTCBB: WSEG) (Thu, April 17, 2008, 9:3 0am ET) Western Standard Energy Corp., (hereafter "Western Standard" or "the Company"), an oil and gas exploration company, is pleased to announce its second drilling permit from the Bureau of Land Management, a department of the U.S. Department of the Interior. The permit was granted to its operator partner, Coastal Petroleum, for a second well on the Starbuck East prospect in Valley County, Montana. The permit pertains to a well location at Federal 1-21, which is a step-out well from the exploration well at Federal 1-19 drilled to approximately 1,000 feet in October, 2007, and currently remains on hold for completion and testing due to Federal land restrictions on access and usage until July 1 based on environmental and wildlife obligations.
The timing of the permit came prior to the recent results of a US Geological Survey ("USGS") report that assessed the Undiscovered Oil Resources in the Williston Basin where Western Standard has a 50% interest in the Starbuck East Prospect, as well a 25% interest in a State Lease, both areas combined to approximately 100,000 acres in Valley County, Montana. This is in addition to the company's 8 Lodgepole Reef prospects within the Williston Basin, in North Dakota.
According to the report released on April 10 by the USGS, "North Dakota and Montana have an estimated 3.0 to 4.3 billion barrels of undiscovered, technically recoverable oil in an area known as the Bakken Formation." This estimate shows a significant leap from an estimate made by the government agency during its last assessment of the area in 1995, which showed a potential recoverable 151 million barrels of oil.
"Upon successful completion of our exploration well at the Federal 1-19, we plan to drill a second well on the Starbuck East lease at Federal 1-21," stated Dan Bauer, President and CEO of Western Standard Energy. "With the recent assessment by the USGS on the potential for this area, we have plans for further land acquisitions and will continue to assess opportunities to exploit the production potential of our current prospects."
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