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OPSY, NVSR, ALRX, AVNR, LFBG, NXGH, August 11 Daily Market Movers Digest Report from OTCPicks.com
(M2 PressWIRE Via Acquire Media NewsEdge) Our Stocks to Watch today include Optical Systems Inc. (OTC: OPSY), NavStar Technologies Inc. (OTC: NVSR), AlphaRx Inc. (OTCBB: ALRX), AVANIR Pharmaceuticals Inc. (Nasdaq: AVNR), Left Behind Games Inc. (OTCBB: LFBG) and NXGen Holdings Inc. (OTCBB: NXGH).
Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover's Digest Newsletter and Email Stock Watch Alerts.
OPTICAL SYSTEMS INCORPORATED (OTC: OPSY) "Up 11.76% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/OPSY.php
Company Profile: http://www.otcpicks.com/optical-systems/optical-systems.htm
Optical Systems, Inc., through its operating subsidiary, Automotive Software Designers, Inc., develops technology and services for the automotive retail industry designed to maximize productivity and increase profits at auto dealerships. ASDI's flagship technology solution, Save-a-Deal, is a turnkey customer relationship management (CRM) tool for auto dealerships. Our business development center (BDC) provides a variety of services designed to help auto dealerships drive traffic to their showroom or Web site, retain customers and generate new streams of revenue.
OPSY News:
August 10 - ASDI Partners With Triple Protection Auto Care, Inc. to Sell Identity Theft Recovery Product
Innovative ID Theft product gives 'peace-of-mind' to consumers and dealers concerning the growing reality of identity theft crimes
Automotive Software Designers, Inc. (ASDI), a leading provider of software and services for the automotive retail industry, and a wholly owned subsidiary of Optical Systems, Inc. (OTC: OPSY), announced a partnership with Triple Protection Auto Care, Inc. (Tri-PAC) to market IdentiTheft , a breakthrough identity theft solution for consumers that is sold on behalf of automotive dealers.
"We're excited to partner with an industry leading CRM services provider like ASDI," said Keith Cooper, President and CEO of Tri-PAC. "ASDI's CRM package will allow dealers to market automotive consumer products outside the scope of the F & I office. In a time where lenders are restricting the dealerships' ability to finance additional consumer products & services, ASDI's approach is refreshing."
IdentiTheft provides a professional ID Theft Recovery Advocate Program to fully manage the restoration process and restore customers' identity to pre-event status should they become a victim of identity theft.
"We believe ASDI and Tri-PAC are a perfect fit, and anticipate rapid results," said Tri-PAC Director of Operations, Danny Madigan. "In addition, ASDI's CRM solution acts as a form of contract production - 'performance risk mitigation' for many of our dealer clients who are utilizing our Information Defense-Red Flag Compliance tool."
Under the terms of the agreement, ASDI will market the IdentiTheft solution through its newly re-engineered business development center (BDC), which provides a broad range of customer relationship management products and services to auto dealerships.
The Federal Trade Commission received over 300,000 ID theft complaints in 2008, an increase from about 250,000 in 2007. ID theft was the biggest complaint received by the agency, and represented 26 percent of all the complaints it received in 2008. Another surprise in the 2008 statistics is that twenty-somethings are most likely to get hit with ID theft.
Nearly every day, there are new reports of sensitive personal information being lost or stolen. Identity theft leaves its victims emotionally devastated as they try to restore their good name, a process that may take years.
"There are more than 26,000 automotive dealerships and more than 7,000 recreational vehicle dealerships in the United States," said BJ Grisaffi, President and Chief Executive Officer of Optical Systems, Inc. "Dealerships today, more than ever, need to make their customers feel secure. IdentiTheft offers everything a dealership needs to accomplish that goal. We have a tremendous market opportunity and intend on seizing it."
ABOUT TRI-PAC
Incorporated in 2002, Triple Protection Auto Care, Inc. is recognized as an industry leader in providing vehicle retailers with cutting edge, market-relevant products, services and solutions. Headquartered in Centennial, Colorado , Tri-PAC established its "foot-print" by developing, distributing and managing, dealer-branded, pre-paid maintenance programs and customer retention tools. In 2005 Tri-PAC pioneered the automotive industry's first Identity Theft Restoration and Recovery consumer deliverable, IdentiTheft . Following the praise of the consumer deliverable, in 2006 Tri-PAC, along with its strategic partners, developed and introduced Information Defense(TM), a dealership operational tool providing a solution for addressing all state breach notification requirements, Gramm-Leach-Bliley Legislation as well as Red Flag compliance. With over 100 Agent Partners nationally, Tri-PAC is the innovative product provider for today's retail vehicle dealer.
NAVSTAR TECHNOLOGIES INCORPORATED (OTC: NVSR)
Detailed Quote: http://www.otcpicks.com/quotes/NVSR.php
Company Profile: http://www.otcpicks.com/navstar-technologies/navstar-technologies.htm
NavStar is focused on the creation of GPS products and services that provide wireless tracking of vehicles, equipment, and other valuable and personal assets. The goal is to be a total solutions provider.
NVSR News:
August 11 - NavStar Technologies, Inc. Begins Procedures to Uplist on Pinksheets, From Limited to Current Information
NavStar Technologies, Inc. (OTC: NVSR), a multinational firm focused on developing and commercializing asset tracking and monitoring devices for vehicles and high value cargo, today announced that it is undertaking all measures necessary in order to become listed as a Current Information Company on Pinksheets.com listings.
"We are pleased to announce that we will be submitting all necessary filings in order to be listed as a Current Information Company with Pinksheets.com. This is one of many steps we are planning in order to become a fully listed OTCBB company. Such a move can only prove beneficial to our shareholders in permitting us to be completely transparent and as such gain the confidence of our investors," said N. Douglas Pritt, Chairman & CEO, NavStar Technologies, Inc. "This decision is consistent with our long term plans for expansion, growth and development. Our company has come a long way and we feel that the best is yet to come."
ALPHARX INCORPORATED (OTCBB: ALRX)
Detailed Quote: http://www.otcpicks.com/quotes/ALRX.php
Company Profile: http://www.otcpicks.com/alpharx/alpharx.htm
AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary site-specific nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development.
ALRX News:
August 10 - AlphaRx Receives China Patent on Its Drug Delivery Platform
AlphaRx Inc. (OTCBB: ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that it has been granted a comprehensive patent in China for its topical platform technology entitled "Vehicle For Topical Delivery of Anti-Inflammatory Compounds." The platform is an integral part of the Company's clinical stage product candidate Indaflex.
"China represents a major opportunity for AlphaRx because of its huge and growing market for innovative therapeutics products," said AlphaRx President and CEO Michael Lee. "The granting of this patent from the Chinese government intellectual property authority helps protect our innovative drug delivery technology and further endorses our competitive position in China."
In April 2006, AlphaRx licensed the global rights (with the exception of Asia and Mexico) for Indaflex to Proprius Pharmaceuticals, Inc. Under the terms of the agreement, AlphaRx is eligible to receive milestone payments of up to $116 million for the successful development and commercialization of Indaflex, as well as double-digit royalties on sales. Proprius was acquired by Cypress Biosceince Inc., in March 2008.
ABOUT INDAFLEX
Indaflex is AlphaRx's topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation under clinical development for the symptomatic treatment of osteoarthritis. Arthritis is the most common chronic disease in North America and afflicts an estimated 10% of the world's population. Indaflex's active ingredient, Indomethacin, has a long-standing and proven clinical treatment record. With AlphaRx's enhanced proprietary delivery system, the company believes its' clinical effectiveness will be significantly enhanced compared to other topical preparations. Topical Indaflex delivery, the company hopes, may circumvent the significant GI side-effects commonly found with orally ingested NSAID's.
AVANIR PHARMACEUTICALS (NASD: AVNR) "Up 55.68% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/AVNR.php
AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. AVANIR's lead product candidate, Zenvia, is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores.
AVNR News:
August 11 - AVANIR Announces Positive Phase III Study Results for Zenvia
* Zenvia Met Primary Efficacy Endpoint in Confirmatory Trial
* Zenvia Demonstrated Improved Safety and Tolerability Profile
AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) announced that the investigational drug Zenvia (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in the confirmatory Phase III STAR trial. Both Zenvia 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). In an additional analysis of the primary endpoint, at week twelve (end of study), patients in the Zenvia 30/10 mg group reported a statistically significant mean reduction of 88% from baseline in PBA episode rates (p=0.01). Also in this study, Zenvia was generally safe and well tolerated. AVANIR management will conduct a conference call to discuss this announcement on August 11 at 5:00 AM PDT (8:00 AM EDT).
"Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones. The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience," said Jeffrey Cummings, MD, Augustus Rose Professor of Neurology at the David Geffen School of Medicine at UCLA and Steering Committee Chairman for the STAR trial. "With no FDA approved treatments currently available, there is a real unmet medical need for the estimated 2 million patients in the U.S. living with the burden of PBA."
"The STAR data indicate that the new low dose Zenvia formulations offer an improved safety and tolerability profile while continuing to deliver statistically significant and clinically meaningful efficacy in the treatment of PBA," said Keith Katkin, AVANIR's President and CEO. "We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the STAR trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010."
Efficacy Results
The primary efficacy analysis was based on the changes from baseline in crying/laughing episode rates recorded in the patient diary. Episode counts were reported and analyzed as a rate expressed as episodes per day. The primary outcome was the additional reduction in episode rates experienced with Zenvia 30/10 mg compared to placebo. In the STAR trial, Zenvia 30/10 mg provided a 47.2% incremental reduction in episode rates compared to placebo over the course of the study (p<0.0001). In a secondary analysis of the primary endpoint, Zenvia 20/10 mg also provided a statistically significant incremental reduction of episode rates compared to placebo (p<0.0001).
An important secondary endpoint analysis was based on the change from baseline to end of study using the Center for Neurologic Studies Lability Scale (CNS-LS). The CNS-LS is a validated instrument measuring the frequency and severity of PBA. In this secondary endpoint analysis, patients receiving Zenvia 30/10 mg reported a significantly greater reduction in mean CNS-LS score compared to patients who received placebo (p=0.0002).
Additional secondary endpoints were included to help expand the Company's understanding of the potential clinical utility of Zenvia. These additional endpoints include: 1) SF-36 Health Survey, 2) Neuropsychiatric Inventory Questionnaire (NPI-Q), 3) Beck Depression Inventory (BDI-II), and 4) Pain Rating Scale score (MS patients only). Data from these secondary efficacy endpoints, as well as additional exploratory analyses, are expected to be reported at an upcoming scientific meeting later this year.
Safety and Tolerability Results
Overall, Zenvia was generally safe and well tolerated in this study. In the STAR trial, 90.9%, 82.2% and 86.2% of patients completed the 12-week double blind phase of the study in the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The most common reason for early withdrawals was due to adverse events (AEs). Early withdrawal due to AEs occurred in 3.7%, 7.8% and 1.9% for the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The proportion of patients reporting at least one AE was 83.2% in the Zenvia 30/10 mg group, 80.4% in the Zenvia 20/10 mg group and 81.1% in the placebo group. Reported AEs were generally mild to moderate in nature. The most commonly reported adverse events that appeared to be more frequent than placebo were dizziness, nausea and diarrhea. While commonly reported, falls, headache, somnolence and fatigue were no different than placebo.
The proportion of patients reporting at least one serious adverse event (SAE) was 6.5% in the Zenvia 30/10 mg group, 8.8% in the Zenvia 20/10 mg group and 10.4% in the placebo group. A total of 38 SAEs occurred in 27 patients over the course of the study. Of the 38 SAEs reported in the study, only two were deemed by the investigators to be possibly or probably treatment-related; zero in the Zenvia 30/10 mg group, two in the Zenvia 20/10 mg group and zero in the placebo group. In addition, there was a numerical difference in respiratory SAEs with five patients (4.7%) in the Zenvia 30/10 mg group, three patients (2.9%) in the Zenvia 20/10 mg group and two patients (1.9%) in the placebo group experiencing respiratory SAEs.
Overall, there were seven deaths in the study, all in patients with underlying ALS. In total, three deaths occurred in the Zenvia 30/10 mg arm, three in the 20/10 mg arm and one in the placebo arm. Of the seven deaths that were reported, five of the deaths (four in the Zenvia treatments arms and one in the placebo arm) occurred at least five days after study drug had been discontinued. There was one reported death in the Zenvia 20/10 mg group that was considered possibly treatment-related, which occurred five days after study drug had been discontinued.
During the study, there were no significant changes observed in laboratory values from baseline to end of study in any treatment group. In order to evaluate the potential for respiratory depression, nocturnal oxygen saturation was measured. There was a decrease in mean nocturnal oxygen saturation of 0.7% in the Zenvia 20/10 mg group (p=0.0472); however, no difference was observed in the higher 30/10 mg dose group relative to placebo.
Cardiovascular Safety
During the course of the study, no new cardiovascular safety signals were observed. There were no clinically meaningful changes in QT interval, no reported pro-arrhythmic events and no reports of any cardiovascular SAEs.
"Overall, the STAR data would suggest that the new low dose formulation of Zenvia provides an improved safety and tolerability profile relative to the previous formulation," said Randall Kaye, MD, AVANIR's Chief Medical Officer. "We look forward to receipt and analysis of the full data set from the double blind phase of the STAR trial as well as results from the open-label extension study to further evaluate the safety and efficacy of the new dose formulations."
Star Trial Design
The STAR (Safety, Tolerability and Efficacy Results of AVP-923 in PBA) trial is a confirmatory Phase III trial of Zenvia in patients with pseudobulbar affect (PBA). The randomized, multi-center, international STAR trial compares active treatment with Zenvia 30/10 mg BID and Zenvia 20/10 mg BID to placebo during a three-month, double-blinded phase, followed by a three-month, open-label extension study. At the conclusion of enrollment, AVANIR had enrolled a total of 326 patients (197 with underlying ALS and 129 with underlying MS) who exhibited signs and symptoms of PBA across 52 sites in the U.S. and Latin America. A total of 110, 107 and 109 patients were randomized to the Zenvia 30/10 mg group, the Zenvia 20/10 mg group and the placebo group, respectively. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries. Secondary endpoints for this clinical trial include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score; 2) Neuropsychiatric Inventory Questionnaire (NPI-Q); 3) SF-36 Health Survey; 4) Beck Depression Inventory (BDI-II); and 5) Pain Rating Scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables. The STAR trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA).
ABOUT PBA
Pseudobulbar affect (PBA), also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact approximately 2 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury. PBA episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a "short circuit" and triggering involuntary PBA episodes. PBA has been shown to impair the lives of patients in both social and occupational settings. There are currently no FDA approved treatments for PBA.
ABOUT ZENVIA
Zenvia (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for Zenvia in the treatment of PBA. The Company is conducting a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. For more information about this trial visit www.pbatrial.com. For more information about the Agency's SPA process, see www.fda.gov/cder/guidance/3764fnl.htm. In addition, AVANIR has conducted a Phase III study of Zenvia in DPN pain where the primary endpoints were successfully met. Subsequently the Company released top-line results of a formal PK study that identified alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. AVANIR is now engaged in discussions with the FDA under the SPA process regarding the design of the next Phase III study in DPN pain and overall program requirements.
LEFT BEHIND GAMES INCORPORATED (OTCBB: LFBG) "Up 31.25% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/LFBG.php
Left Behind Games, Inc. engages in the development, publishing, and distribution of video games and related products in the United States. The company develops its video game products based on the Left Behind series of novels and products. Its primary product includes LEFT BEHIND: Eternal Forces, a real time strategy game played by one person or online by up to eight players on personal computers. The company sells its products through a direct-to-store distribution channel or through distributors to Christian booksellers association and inspirational marketplaces. It markets its products in North America, Australia, Canada, Singapore, and South Africa. Left Behind Games, Inc. was founded in 2002 and is based in Murrieta, California.
LFBG News:
August 11 - Left Behind Games gains momentum in preparation for holiday season sales
Left Behind Games Inc. (OTC: LFBG), dba Inspired Media, a leading publisher of Christian video games, reports recent developments that are anticipated to provide sustainable profitability before the end of its fiscal year ending March 31, 2010. Most significant is the announcement that Jack of All Games (a Take-Two Interactive Software company) will launch distribution of the Left Behind Games product line on August 25, 2009 with the expectation that games will be available in major retail locations sometime in September. All packaging for the games has been upgraded and, in some cases, will include embossed titles and case slipcovers. Interested retailers should contact their Jack of All Games representative.
The Company recently announced that Wal-Mart will test five of its products in stores during the Christmas holiday season. Preliminary discussions indicate trial marketing will begin on September 28, 2009 and focus on a region favorable to faith-based demographics; potentially Texas. The Company plans a significant marketing push for the trial and will publish details as they become available.
CEO, Troy Lyndon, says, "We expect our bottom line profit to increase substantially in coming quarters as a result of recent aggressive efforts to implement our four-fold marketing plan. Our strategy encompasses marketing through mainstream retailers, the church marketplace, Christian stores and our upcoming online store. Our family-friendly online store will be launched before the end of the quarter, and at that time our products, in addition to more than a thousand family-friendly games, will be available for copy-protected download."
The Company currently publishes six games including Tribulation Forces, the sequel to the original game LEFT BEHIND: Eternal Forces, known as the most widely distributed Christian PC game in history. The Company's LEFT BEHIND branded games are based upon the popular novel series by Tim LaHaye and Jerry Jenkins which have sold more than 65 million books in 30 languages worldwide.
In contrast to many other PC games, Inspired Media games encourage positive decisions and actions. Rather than the usual "winning" by using weapons and killing the enemy, players are rewarded when their characters use the power of influence to bring about good rather than destruction.
NXGEN HOLDINGS INCORPORATED (OTC: NXGH) "Up 13.79% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/NXGH.php
NXGen Holdings, Inc., through its wholly owned subsidiary, Green Bridge Industries, Inc., offers non-toxic, environmentally friendly cleaning products to fit the sanitation needs of the medical, agricultural, military and retail markets. The Company, through its proprietary technology, has the ability to develop 100% all natural cleaning products, which are superior to the synthetic products currently offered in the marketplace. The Company's products are safe for the surfaces it cleans, the environment, animals and humans.
NXGH News:
August 11 - NXGen Holdings, Inc.'s Subsidiary to Launch Marketing and Sales Campaign Towards the Government and Military Sector
NXGen Holdings Inc. (OTCBB: NXGH) announced that the Company's wholly owned subsidiary, Green Bridge Industries, Inc., has entered into an agreement with Leading Points Corporation to help Green Bridge secure purchase orders with various government and military agencies. Leading Points will assist the Company in developing a marketing and sales strategy for the military and government sector as well as perform a number of services for the Company to include developing national brand and licensing opportunities for its line of "green" cleaning products. The agreement will allow Green Bridge Industries to immediately introduce its product line to 34 million Americans in the military market with nearly $2 trillion in annual purchasing power. In addition, the Company will be able to reach out to the Federal Government, which, according to TargetGov.com, spends over $400 billion every year purchasing products and services of virtually every type from businesses large and small through out the United States.
Leading Points has the experience to assist Green Bridge Industries in implementing a marketing strategy targeted directly to the Federal Government, the military demographic as well as private and non-profit organizations that cater to U.S. Military personnel, both active and retired. Founded and led by Lieutenant Colonel Kevin Sullivan U.S. Army (Retired), Leading Points' concept involves drawing on established relationships and continuously building new ones among buyers and management of the military and the government. They have helped businesses of all types go from overlooking a powerful market to virtually overnight success stories.
"I look forward to bringing my network of commercial and military associates on board to assist in the development of Green Bridge Industries. Green Bridge Industries has a fantastic line of green products that I am happy to promote and bring to market," stated Kevin Sullivan, President of Leading Points Corporation.
"I am very pleased to have Leading Points working directly for us on developing relationships not only with government and military entities, but also with presenting Green Bridge Industries with national branding and licensing opportunities as well," stated William White, Chairman and CEO of NXGen Holdings, Inc.
ABOUT LEADING POINTS CORPORATION
Leading Points Corporation, founded in 2004, specializes in marketing to the military market. They are considered the experts in matters of securing placement of their clients' products in the military exchange store distribution channel as well as special promotions to the military community. The company is headquartered in Centennial, Colorado.
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