StandoutStocks.com: "Stocks that Standout" picks for today are: CERP, GTHP, PGOG, PYMX, SYVC

Dec 10, 2008 (M2 PRESSWIRE via COMTEX) -- SYVC | Quote | Chart | News | PowerRating -- Dec 10, 2008 StandoutStocks.com "Stocks that Standout" picks for today are: Cereplast, Inc. (OTCBB: CERP), Guided Therapeutics, Inc. (PINKSHEETS: GTHP), Perf Go Green Holdings, Inc. (OTCBB: PGOG), PolyMedix, Inc. (OTCBB: PYMX), Synovics Pharmaceuticals, Inc. (OTCBB: SYVC)...and Proudly Introducing Proprietary Push Technology (PPT).

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Dec 10, 2008 -- Cereplast, Inc. (OTCBB: CERP), manufacturer of proprietary bio-based sustainable plastics, today announced it has entered into a common stock purchase agreement to sell up to $20,000,000 of common stock to Cumorah Capital, Inc.

Under the agreement, Cereplast has the right to sell shares of its common stock to Cumorah Capital from time to time, depending on certain conditions, for an aggregate amount of up to $20,000,000. The purchase price of the shares will be determined based upon the market price of the Company's shares at the time of each sale, and Cereplast will control the timing and amount of any sales of shares to Cumorah Capital. The stock purchases can occur over a 24-month period of time.

"Cumorah Capital has been a Cereplast shareholder since 2006 and we are pleased that they have agreed to purchase additional shares," said Frederic Scheer, Chairman and CEO of Cereplast. "We appreciate the confidence they have shown in Cereplast by entering into this common stock purchase agreement."

A more detailed description of the agreement is set forth in the Company's current report on Form 8-K to be filed with the SEC which should be reviewed carefully in conjunction with this news release.

About Cereplast

Cereplast, Inc. designs and manufactures proprietary bio-based, sustainable plastics which are used as substitutes for petroleum-based plastics in all major converting processes - such as injection molding, thermoforming, blow molding and extrusions - at a pricing structure that is competitive with petroleum-based plastics. On the cutting-edge of bio-based plastic material development, Cereplast now offers resins to meet a variety of customer demands. Cereplast Compostables(R) Resins are ideally suited for single use applications where high bio-based content and compostability are advantageous, especially in the food service industry. Cereplast Hybrid Resins(R) combine high bio-based content with the durability and endurance of traditional plastic, making them ideal for applications in industries such as automotive, consumer electronics and packaging.

Dec 10, 2008 -- Guided Therapeutics, Inc. (GT) (PINKSHEETS: GTHP | Quote | Chart | News | PowerRating) today announced it submitted the first of three modules of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the LightTouch(TM) non-invasive cervical cancer detection device.

"Submitting the Preclinical Module of our PMA is a highly significant event for the company and is a key step in gaining access to the multi-billion dollar U.S. cervical cancer detection market," said Mark L. Faupel, Ph.D., GT President and CEO. "The submission is the culmination of several years work by the company that we believe, if the device is approved, will create value for our shareholders and bring an important new technology to help save women's lives. We are now focused upon completing and submitting the Clinical and Manufacturing modules early next year."

The content and schedule for submitting the modules, which represent major sections of the entire PMA application, were agreed to in advance by GT and the FDA. The PMA is reviewed by FDA staff and a panel of experts. The technology has already undergone safety evaluations by FDA and is considered to be non-significant risk by hospital institutional review boards.

The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately.

Approximately 1,900 women were tested in the PMA pivotal clinical trial to demonstrate the technology's accuracy in detecting cervical disease. In all, nearly 3,000 women have enrolled in studies using LightTouch prototypes with no instances of significant or unexpected adverse events.

According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive LightTouch test has the potential to be significantly more accurate when compared to the Pap test and Human Papilloma Virus test, two standard tests women currently undergo for cervical screening and diagnosis.

Research and commercialization of the device were funded, in part, by grants from the National Cancer Institute and Georgia Research Alliance. Clinical trial sites include the University of Miami, The University of Texas Southwest, Emory University/Grady Memorial Hospital in Atlanta, the Medical College of Georgia in Augusta, GA, St. Francis Hospital/University of Connecticut in Hartford, Orange Coast Women's Center and Saddleback Women's Center in California.

About Guided Therapeutics

Guided Therapeutics, Inc. (Pink Sheets: GTHP | Quote | Chart | News | PowerRating) is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to provide an objective result at the point of care thereby improving the management of cervical disease. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. The company also owns technology for measuring substances in interstitial fluid, a secondary circulatory system in the body that surrounds the cells.

The Guided Therapeutics LightTouch(TM) Non-invasive Cervical Cancer Detection Device is an investigational device and is limited by federal law to investigational use.

Dec 10, 2008 -- Perf Go Green Holdings, Inc. ("Perf Go Green") (OTCBB: PGOG | Quote | Chart | News | PowerRating) (www.perfgogreen.com), a marketer and distributor of biodegradable plastics, today announced the company's first major hospital conversion with Lehigh Valley Hospital and Health Network (LVHHN) in Pennsylvania. Beginning in December, LVHHN will use Perf Go Green's trash bags in all of its hospital and health services facilities. LVHHN's three hospitals have a combined total of nearly 1,000 beds, 1,100 physicians on staff, 1,900 registered nurses and are the area's largest employers with a work force of more than 9,500.

"We're delighted that such a prominent institution as LVHHN recognizes the contribution Perf Go Green can make to reduce the environmental impact of its daily operations," said Chairman and CEO Tony Tracy. "Our commercial product can be tailored for all kinds of applications and offers an important way for health care facilities, which by necessity generate large amounts of waste, to do the right thing for our environment. Hospitals are an important target group for Perf Go Green, and we're thrilled that LVHHN is setting a trend for other health care institutions to follow."

Linda Zengen, LVHHN waste reduction specialist, added, "LVHHN is committed to reducing its carbon footprint, and these biodegradable bags will go a long way in helping us accomplish that goal. So we are not only helping the environment by switching to these bags, but are also saving money. It's a huge cost savings for the organization."

Perf Go Green's corporate name reflects its "Go Green" mission to develop, market and distribute biodegradable plastic products as a practical and viable solution to eliminating plastic waste from the world environment. Founded in November 2007, Perf Go Green premiered at the March 2008 International Home and Housewares Show in Chicago, where its products were honored for their design quality and innovation. Perf Go Green's household products -- which include tall kitchen trash bags, lawn & leaf bags, pet products, plastic drop cloths, and other items -- are now available at stores with more than 22,000 retail units and online at Amazon.com and drugstore.com.

LVHHN's conversion to Perf Go Green's biodegradable trash bags is part of the organization's comprehensive environmental program. LVHHN has also implemented a series of recycling initiatives, invested in energy-efficient lighting, heating and cooling systems, installed reflective roofing materials, and taken other steps to reduce its environmental impact.

A premier academic community hospital, Lehigh Valley Hospital and Health Network includes three hospital facilities -- two in Allentown and one in Bethlehem, Pa. -- and Lehigh Valley Health Services, providing home health, hospice, pharmaceutical and health management services and the 400-member Lehigh Valley Physician Group of primary care and specialist physicians. In 2008, US News & World Report named Lehigh Valley Hospital one of America's Best Hospitals for the thirteenth straight year. LVHHN's advanced regional resources include the region's busiest, most-experienced trauma center caring for adults and children, regional Burn Center as well as kidney and pancreas transplant, perinatal/neonatal, cardiac, cancer care, and neurology and complex neurosurgery capabilities. LVHHN hospitals are designated national Magnet hospitals for excellence in nursing. LVH is one of Pennsylvania's largest teaching hospitals and is a major teaching campus of Penn State's College of Medicine.

About Perf Go Green

Perf Go Green Holdings, Inc. is engaged in the distribution and global marketing of eco-friendly, non-toxic, food-contact-compliant, biodegradable plastic products. All Perf Go Green products incorporate recycled plastics that are combined with an oxo-biodegradable proprietary application method to produce the film for the products. Based on environmental claims statements made by the manufacturer of the oxo-biodegradable applied to our products, when discarded in soil and exposed to the presence of microorganisms, moisture and oxygen, we believe Perf Go Green products biodegrade within two years, decomposing into simple materials found in nature much faster than regular plastics, which can take hundreds of years to break down. Through this process and the use of recycled plastics, Perf Go Green effectively removes plastic waste from the environment. In addition, Perf Go Green trash bags utilize a unique patented dispensing system that stores the bags on the bottom of trashcans and dispenses them one at a time, similar to a tissue box.

Dec 10, 2008 -- PolyMedix, Inc. (OTCBB: PYMX), an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders based on biomimetics, has successfully completed its first-in-man Phase I clinical safety study with the novel antibiotic drug candidate PMX-30063. PMX-30063 is the first and only small molecule mimetic of host defense proteins in clinical development, with a novel mechanism of action distinct from other antibiotic drugs, that is believed to work in such a way that makes bacterial resistance unlikely to develop. The data from the study demonstrate that safe and well-tolerated single doses were achieved, at levels suggesting and a beneficial therapeutic index may be possible. Further clinical development will continue for the initial indication for this drug as a treatment for pan-Staphylococcal infections.

This ascending single-dose intravenous pharmacokinetic and safety study met the necessary Phase I goals of defining both a limiting single dose and the plasma distribution/elimination kinetics.

A comparison between microbiologically effective drug levels (from preclinical studies in animals) and the plasma drug levels measured in this human study suggests that it should be possible to achieve clinically therapeutic levels with daily doses of PMX-30063 which are lower than those associated with any adverse effects seen in this single dose study.

In this study the dose was not limited by any measurable clinical or laboratory parameters. A subjective syndrome was identified, appearing only at the higher dosages and consisting of abnormal neuronal sensations often likened to dental anesthesia. These effects were graded as mild to moderate by investigators or subjects, but their reproducibility and dose-proportionality allowed dose-escalation to be successfully concluded after achieving levels well in excess of the expected therapeutic range. The effects were temporary and resolved on their own.

Study Details

A total of twenty-two normal subjects each received a single dose from an escalating range of up to 2.5 mg/kg. A total of seven different dose levels were administered. There were no clinically relevant adverse effects at doses under 0.54 mg/kg, and no clinically significant trends in laboratory parameters at any dose. At 0.54 mg/kg and above (1.0, 1.25, and 2.5 mg/kg), a syndrome of subjective effects without objective correlates became more prominent as dosage increased. This syndrome consisted of paresthesias, usually beginning in the oral area, and often with subsequent extension to one or more of the following areas: face, scalp, extremities, upper thorax, and/or perineum (groin and buttocks). The degree of extension appeared to correlate with dosage increase. Although sometimes brief, the symptoms typically lasted from hours to days. All symptoms were temporary, and fully resolved on their own. No adverse effects were classified as serious or severe, but the pattern of increasing severity from mild to moderate with increasing dosage suggested that dose escalation could be halted at 2.5 mg/kg while still satisfying the objectives of the study.

The plasma-level assays indicate highly favorable drug behavior, with simple exponential kinetics providing an excellent fit to the observed data, and distribution and elimination half-times of the order of 1.5 hours and 15 hours respectively in the expected clinical dosage range. Peak plasma levels in mcg/mL were consistently found to be about 15 times the dose (in mg/kg), so that 0.18 mg/kg (a dose without observed ill effects) resulted in a mean maximum drug level ("Cmax") of 2.7 mcg/mL, and the 0.54 mg/kg dose (where mild neuronal symptoms were first reported) had a mean Cmax of 8 mcg/mL.

As seen in data presented by PolyMedix at the American Society of Microbiology ICAAC 2008 meeting, PMX-30063 has demonstrated MIC's (Minimal Inhibitory Concentration, the amount of drug needed for killing of the bacteria) of 0.25 to 1 mcg/mL against Staphylococcus aureus and other coagulase-negative forms, including methicillin-sensitive and vancomycin- and daptomycin-resistant strains, and MIC's of 2 mcg/mL or less against methicillin- and linezolid-resistant strains. Thus, this clinical study demonstrated that it was possible to safely administer single doses of PMX-30063 that achieved blood levels of drug 3.3 times higher than the MIC for MSSA (methicillin-sensitive Staphylococcus aureus) and 1.6 times higher than the MIC for MRSA (methicillin-resistant Staphylococcus aureus) at doses where no adverse effects were reported, and blood levels of 30 times the MIC for MSSA and 15 times the MIC for MRSA at the maximum doses administered in this study. At maximally efficacious doses in pre-clinical infection models, the pharmacokinetic parameters (AUC 0-24 hr and T>MIC) at therapeutic doses were comparable with the same parameters in human subject at doses > 0.18 mg/kg.

Pharmacokinetic modeling with the present clinical data predict that a single daily dose of 0.18 mg/kg would provide steady-state plasma levels exceeding 2 mcg/mL for twelve hours daily and exceeding 1 mcg/mL continuously. The same dose twice-daily, or a once-daily dose of 0.4 mg/kg, would provide plasma levels exceeding 2 mcg/mL for 16 hours and exceeding 1 mcg/mL continuously from the first day of treatment. It is considered unlikely that a therapeutic cure would require supra-MIC levels continuously, in which case even lower doses of PMX-30063 may suffice.

PolyMedix plans to develop PMX-30063 initially for the indication of pan-Staphylococcal infections, the broad treatment of a wide range of Staph infections. Development will continue next with a multi-dose study to confirm safety throughout the expected duration of a clinical course of treatment. The long half-time of the drug will allow exploration of different regimens, so that exposure can be adjusted to both maximize safety and expected efficacy - for example, by dosing more frequently at lower dosages to minimize Cmax, or less frequently at higher dosages to maximize Cmax, while maintaining plasma levels within a desired therapeutic range with either regimen.

"The completion of this first clinical study for PMX-30063 represents a major milestone for PolyMedix, and we believe, for all of medicine," said Nicholas Landekic, CEO of PolyMedix. "This novel antibiotic compound represents a potential fundamental breakthrough in treating infectious diseases. PMX-30063 is the first and only small molecule defensin mimetic in clinical development for the treatment of systemic infections, and the first and only such compound whose mechanism of action is intended to directly address the major problem of bacterial drug resistance. We are very proud to be the first company to be developing this completely new type of antibiotic, and seek to address a major clinical need and market opportunity. We look forward to continuing with further clinical development of PMX-30063."

About PMX-30063

Completely different from other antibiotic compounds currently on the market, PMX-30063 is a synthetic chemical mimic of host defense proteins, one of the oldest and most effective antimicrobial defense systems found in virtually all living creatures. PMX-30063 is the first and only small molecule mimetic of host defense proteins in clinical trials intended to treat systemic infections.

Based on our pre-clinical studies, we believe PMX-30063 has unique properties which set it apart from traditional antimicrobial molecules and materials, including:

-- A novel mechanism of action, the direct biophysical disruption of bacterial cell membranes, that makes development of bacterial resistance unlikely;

-- Activity against both Gram-positive and Gram- negative bacteria, and in particular, activity against 146 different strains of Staphylococcus bacteria, including 89 drug-resistant strains of Staph bacteria;

-- Bactericidal activity, meaning it kills bacteria directly, rather than simply stopping reproduction (bacteriostatic) as do many current antibiotics;

-- Faster acting than many antibiotics; and

-- Activity against drug-resistant bacteria, including clinical isolates of multiple vancomycin-, methicillin-, and daptomycin-resistant strains.

Primitive life forms, such as molds, secrete compounds like penicillin to protect themselves from bacteria. This forms the basis for conventional antibiotics - compounds which act against biochemical targets or pathways in bacterial cells. Multi-cellular organisms, such as insects, animals, and humans, possess a more complex, first-line immune system defense against bacterial infections: the host defense proteins. Host defense proteins are part of the non-humoral (that is, not involving antibodies) response that keep humans from rapidly succumbing to infections. Biologists have discovered many different classes of natural host-defense peptides. Although these molecules possess a diverse array of structures, their physicochemical properties are similar. All are amphiphilic, meaning they have a combination of positively electrically charged properties, and hydrophobic (water-hating, fat-loving) chemical properties. This amphiphilic structure is believed to be responsible for host defense peptides' antimicrobial activity and their unique abilities to directly disrupt bacterial cell membranes. Among the most common and well-studied antimicrobial peptides are the defensins, found in humans, the magainins, found in frogs, and the cecropins and melitins, found in insects.

PMX-30063 is designed to mimic the amphiphilic structure of the host defense proteins, but with a completely synthetic, non-peptide, small molecule structure. PMX-30063 directly disrupts bacterial cell membranes; a mechanism shared with the host defense proteins but is unique among known antibiotic drugs. For this reason, we believe that bacterial resistance is less likely to develop with PMX-30063 than has been experienced with many conventional antibiotic drugs. Multiple serial passage experiments conducted by PolyMedix and others on PMX-30063 and related PolyMedix antibiotic compounds also support our view of a lower likelihood of developing resistance, including as presented at the American Society of Microbiology's ICAAC Conference, Washington D.C., October 26-27, 2008.

The first intended clinical indication for PMX-30063 is as a pan-Staph agent, for the broad treatment of Staph infections, not only Methicillin-Resistant Staphylococcus aureus ("MRSA") but including many other forms of Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus hemolyticus and others. Staph infections are one of the most common infections requiring hospitalization and treatment with antibiotics administered in hospitals, and one of the fastest growing types of infections. The incidence of Staph infections has increased 700% over the past four years. Staph infections may be manifested in many ways, including skin and soft tissue infections, respiratory infections (Staph pneumonia), gynecological infections, and abdominal infections. What is commonly called "MRSA" is but one form of Staph infection which is resistant to conventional antibiotics, methicillin-resistant Staphylococcus aureus. There are many forms of Staph bacteria which are resistant to many antibiotics, including marketed drugs such as vancomycin, linezolid, and daptomycin. Studies by PolyMedix against 89 different drug-resistant forms of Staph bacteria have demonstrated the activity of PMX-30063 against all of them, including those strains resistant to marketed drugs. We believe the activity of PMX-30063 against a broad range of many types of Staph bacteria, including those resistant to currently marketed drugs such as vancomycin, daptomycin, and linezolid, makes it unique among investigational antibiotic drugs.

Significant further clinical studies and other additional drug development work will be needed in order to obtain regulatory approval for the commercial sale of PMX-30063.

About PolyMedix, Inc.

PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of infectious diseases and acute cardiovascular disorders. PolyMedix's compounds are based on biomimetics: non-peptide small molecule drug candidates and polymers that mimic the activity of proteins. The Company's antibiotic compounds, including PMX-30063 - small molecule mimetics of human host-defense proteins - have a completely different mechanism of action from current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. The Company's goal is to develop these compounds as rapidly acting antibiotics for serious systemic and local infections. The Company plans to continue the development of polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. The Company's heptagonist compounds, including PMX-60056, reverse the activity of both heparin and Low Molecular Weight Heparins, with the goal of developing an antagonist drug that is safer and easier to use than currently approved therapy. The Company's PMX-30063 antibiotic and PMX-60056 heptagonist are currently undergoing clinical testing.

Dec 10, 2008 -- Synovics Pharmaceuticals, Inc. (OTCBB: SYVC), a specialty pharmaceutical company, today announced a further reduction of its debt by paying off the last remaining $780,000 of the "Kirk 2008 Bridge Loan" through the sale of additional Series C Convertible Redeemable Preferred Stock ("Series C Preferred Stock") in that amount.

As previously reported in the Current Report on Form 8-K dated May 15, 2008, the Company completed an initial closing on May 9, 2008 of its Series C Preferred Stock offering (the "Series C Offering"). On August 21, and September 25, 2008 the Company completed additional closings of its Series C Offering whereby, in consideration for a total additional investment of $1.78 million, Synovics sold to Svizera Holdings BV ("Svizera"), an affiliate of Maneesh Pharmaceuticals, Ltd., a total of 3,560 shares of Series C Preferred Stock, convertible into 3,560,000 shares of common stock, together with warrants to acquire up to an additional 1,780,000 shares of common stock. Svizera (and Maneesh) have invested a total of $14,080,000 as equity in Synovics.

The cash received was used to further reduce the Company's short and long term debt. Total Company debt owed on May 9, 2008 including accrued interest was $20,640,683. Capital provided by investors to Synovics this year, including funds in the latest tranche of the Series C Offering, has allowed the Company to reduce or pay off debt, including satisfying the "Kirk 2008 Bridge Loan" arranged through Axiom Capital Management. As shown in the table below, the current reduced outstanding debt (principal and accrued interest) owed by the Company is $6,190,000, of which $5,650,000 is indebtedness under the Company's credit facility with Bank of India.

October 15, 2008 May 9, 2008 2005 Bridge Notes $0 $4,036,923 2007 Bridge Notes 0 - 2008 Bridge Notes 0 6,917,478 Customer Note 0 644,242 Seller Note 500,000 2,010,000 Bank of India 5,650,000 6,950,000 Other 40,000 82,040 Total $6,190,000 $20,640,683

"The successful restructuring of our balance sheet and the resulting reduction of Company debt has been our goal for the past many months and I am most pleased with this accomplishment," commented Jyoti Gange, Principal Executive Office. "The reduction of debt and related interest costs is expected to have a very positive effect on our operations as we continue to build on and execute our business plan."

"This additional investment in the Synovics by Svizera," stated Ronald Howard Lane, Ph.D. Chairman of the Board, "is evidence of Svizera's ongoing and overall support of our endeavors to grow the Company."

About Synovics:

Synovics is a specialty pharmaceutical company engaged in the development, manufacturing and commercialization of prescription and OTC drugs. The Company has two operating subsidiaries, Kirk Pharmaceuticals, LLC and ANDAPharm, LLC, which manufacture and sell OTC and prescriptions private label or "store brand" drugs, respectively, and a drug development subsidiary, Synovics Labs, Inc., that is pursuing generic drug opportunities. Synovics employs approximately 150 people in its 80,000 sf. Ft. Lauderdale facility. The Company manufactures drug products (including hormonal prescription drugs) in specialized containment suites under its Drug Enforcement Administration licenses. The Company has a Front-End strategy based business plan -- a strategy of sourcing lowest cost, highly competitive generic drug products from India, packaged and marketed to its US customers through its Ft. Lauderdale operations. Synovics' previously announced strategic partnerships with Maneesh Pharmaceuticals, Ltd. and Harcharan (Harry) Singh that represent the Company's cornerstone for its Front-End strategy in India. The Company believes cost is the single most important element in the generic drug industry and it is reaching out through its strategic partners to source products and services from a variety of smaller independent Indian pharmaceutical companies that lack access to the US market.

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