dallas tx 9/12/2009 2:16:39 AM
News / Business

ACCP, CHYU, EWRC, KNDR, OGNG, JAGR, FHAI, BIEL, VSMR, DSCO, SPDE, VIAP OTCPicks.com Daily Market Movers Digest Midday Report for Friday, September 11th

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Our Stocks to Watch today include Access Pharmaceuticals Inc. (OTCBB: ACCP), China Youth Media Inc. (OTCBB: CHYU), eWorld Companies Inc. (OTC: EWRC), Kender Energy Inc. (OTC: KNDR), Organa Gardens International Inc. (OTCBB: OGNG), Jaguar Mining Enterprises Inc. (OTC: JAGR), Fountain Healthy Aging Inc. (OTCBB: FHAI), BioElectronics Corp. (OTC: BIEL), VerifySmart Corp. (VSMR: OTCBB), Discovery Laboratories Inc. (Nasdaq: DSCO), Speedus Corp. (Nasdaq: SPDE) and VIA Pharmaceuticals Inc. (Nasdaq: VIAP).

 

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover’s Digest Newsletter and Email Stock Watch Alerts.

 

ACCESS PHARMACEUTICALS INCORPORATED (OTCBB: ACCP)

"Up 3.12% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/ACCP.php 

 

Company Profile: http://www.otcpicks.com/access-pharmaceuticals/access-pharmaceuticals.htm 

 

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac™, currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard™ for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix®, a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.

 

ACCP News:

 

September 11 - Access Pharmaceuticals Signs Agreement to Manufacture Its FDA-Approved MuGard in the United States

 

Access Pharmaceuticals Inc. (OTCBB: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.

 

In a comparison of cancer patients receiving standard oral mucositis care with those patients receiving MuGard , MuGard has been shown to significantly reduce the incidence and severity of the debilitating side effect of radiation treatment and chemotherapy.

 

Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world's largest pharmaceutical and consumer products companies.

 

"Access is moving forward with the development of MuGard in North America," said Jeffrey B. Davis, Access' President & CEO. "Establishing our relationship with Accupac, a leader in liquid contract manufacturing, is critical to our successful commercialization of MuGard. In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities."

 

Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed. Access hopes to finalize these protocols and begin one or more market seeding studies in Q4 2009.

 

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. Up to 80% of all patients receiving radiotherapy and approximately 40% of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop symptoms. MuGard is currently being marketed in the United Kingdom, Germany, Italy, Norway and Greece by Access' partner, SpePharm.

 

Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide.

 

CHINA YOUTH MEDIA INCORPORATED (OTCBB: CHYU)

 

Detailed Quote: http://www.otcpicks.com/quotes/CHYU.php 

 

Company Profile: http://www.otcpicks.com/china-youth-media/china-youth-media.htm

 

China Youth Media, Inc. is a China-focused youth marketing and media company whose business is to deliver advertising and content to one of the most sought after and fastest growing demographics in the world. Through its wholly owned subsidiary Youth Media (Hong Kong) Limited, CHYU has secured contracts with a term of 20 plus 10 years that provide exclusive rights from the Chinese government controlled corporation, China Youth Interactive, which uniquely position CHYU to market to China’s massive student population with preferred access online, on campus and on mobile. CHYU currently targets China’s campus-based college students, who total more than 30 million and make up a key segment of the largest youth market in the world.

 

CHYU News:

 

September 9 - China Youth Media Launches Converse Ad Campaign on Koobee Network

 

China Youth Media, Inc. (OTCBB: CHYU), a China focused youth marketing and media company, announced that its Koobee Network has launched an advertising campaign for the athletic footwear company Converse, a subsidiary of the world’s leading athletic shoes and apparel company, Nike.

 

Koobee, China Youth Media’s Intranet Television Network and media portal, delivers TV-quality content and advertising directly to China’s 30 million plus college students on a dedicated network targeted to campuses nationwide. The Converse ad campaign is running on Koobee’s recently launched MOGO Music Channel. Produced for and targeted specifically to China’s youth market, the ads feature a nationwide music competition sponsored by Converse that allows young music fans to interact with one of the most popular rock bands in China.

 

“We are very pleased to launch the Converse campaign on Koobee and expect it to become one of many to generate ad revenue for the company,” commented Jay Rifkin, China Youth Media’s CEO. “As more campaigns like this are sold, we believe that Koobee’s highly targeted youth platform will become premium ad inventory for major global brands.”

 

EWORLD COMPANIES INCORPORATED (OTC: EWRC)

"Up 7.14% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/EWRC.php 

 

Company Profile: http://www.otcpicks.com/eworld-companies/eworld-companies.htm

 

eWorld Companies, Inc. is an online marketing & advertising technologies company that develops and markets cutting edge technologies using rich media, flash, animation and 3D graphics to help individuals and businesses market and advertise online. eWorld's revenue model consists of seven components: (1) Affiliation Fees, (2) Affiliate Monthly Subscriptions, (3) Affiliate Benefit Subscriptions, (4) Product Sales, (5) Advertising Revenues, (6) Web Development Accounts, and (7) International Licensing Fees.

 

EWRC News:

 

September 10 - eWorld Companies Board of Directors Approves Offer for Purchase of Outstanding Shares at 1.9 Cents

 

eWorld Companies, Inc. (OTC: EWRC) announced that its Board of Directors has approved an offer for purchase of all outstanding shares at 1.9 cents a share pending completion of due diligence and approval by their attorneys. Upon completion of this due diligence and approval, the company will make a recommendation to its shareholders.

 

eWorld Companies Presents 2nd Annual eWorld Music Awards

 

eWorld Companies, Inc. (OTC: EWRC) presents the 2nd Annual eWorld Music Awards (EMAs), the only event of its kind celebrating truly independent music, voted for by the fans.

 

In conjunction with this release, eWorld CEO Henning Morales stated that over the next few months the eWorld Music Awards and Show will become the company's primary focus, and are expected to play a significant role in the company's near-term goals of generating one to two million new Boomerang downloads and at least $1,000,000 monthly gross profits.

 

The EMA's will also introduce audiences and participants to an exciting new format geared to today's generation of artists and music lovers. Billed as the "World's Fastest Music Award Show - A One-Hour-Only Live Awards Jam," the action will be fast and furious, serving up a live musical performance of a premier Indie band plus 10 live performances by nominees, and delivering 13 separate awards, all in a one-hour broadcast. The live event, which will take place during Grammys week on January 29, 2010, will be broadcast worldwide via the Internet and possibly as a one-hour live television event as well.

 

The EMAs will be held at the famed Barker Hangar in Santa Monica, California, which has played host to some of the most exclusive events in Southern California, including The Vibe Awards, People's Choice Awards and TV Land Awards. Live music performances and celebrity appearances will highlight this star-studded gala. Prior to the show, fans will vote online; the top three artists in each category will go to the live show and perform. The EMAs will also recognize the groundbreaking forces that have been influencing this movement with a Cutting Edge Award for Lifetime Achievement and an Industry Innovator Award.

 

Music submissions are being accepted now at www.eworldmusicawards.com. Nominee selection will be made by a Blue Ribbon Panel of singers, songwriters, producers, and other music industry professionals based on originality and overall quality of each submission. In late November the Panel will begin selecting the top nominees in each category to advance to a final audience voting round. Audience voting will begin online on December 15, 2009, and will remain open up to five minutes before the announcement of each winner at the Awards show. Cash prizes will be awarded to the winners from each category.

 

KENDER ENERGY INCORPORATED (OTC: KNDR)

 

Detailed Quote: http://www.otcpicks.com/quotes/KNDR.php

 

Company Profile: http://www.otcpicks.com/kender-energy.htm

 

Kender Energy Inc. is a development phase company active in the field of solar energy. Its present prototypes of solar panels are being developed into a full-scale solar energy production system. The particularity of the Kender solar panel system and technology is to allow, via a closed circuit of gas (usually helium), to create a heat exchange with the sunlight and the air from the environment. The exchange generates the spinning of the helium gas in the closed circuit, propelling a turbine, which produces electricity in a 100% clean and renewable process. The system's main advantages are that it is efficient, cheap in production, and modular. The company is based near Geneva, Switzerland.

 

KNDR News:

 

September 10 - Kender Energy to Distribute Its Solar Technology in Portugal, the Home of the Largest Solar Photovoltaic Farm

 

Kender Energy Inc. (OTC: KNDR) announced that it has signed a distribution agreement for the country of Portugal with Nortfil Lda of San Pedro.

 

Portugal, without its own oil, coal or gas, is leading the European revolution of clean energy with some of the most ambitious objectives for renewable energy. The country is home to the largest solar power station with over 2,520 giant solar panels expected to produce 45MW of electricity each year, enough to power 30,000 homes.

 

"Portugal's objective is to produce 31% of its energy from clean sources by 2020 and Kender Energy's solar technology will tremendously increase the efficiency in the harvest of solar power," said Sean Kelly, President and CEO of Kender Energy. "Portugal's plan to invest more than $1 billion in a series of solar farms to power 450,000 homes makes this market a major focus for our company," further added Mr. Kelly.

 

September 9 - Kender Energy Publishes Its Corporate Video Profile

 

Kender Energy Inc. (OTC: KNDR) announced that it has published its corporate video profile on its website at www.kendersolar.com/index.php/Kender-Corporate-Video.html.

 

ORGANA GARDENS INTERNATIONAL INCORPORATED (OTCBB: OGNG)

 

Detailed Quote: http://www.otcpicks.com/quotes/OGNG.php

 

Company Profile: http://www.otcpicks.com/Newsletter/OGNA_NA_090909.html

 

Organa Gardens International Inc. has a vertical hydroponics farming system built to make the most efficient use of light, energy, water, land, temperature and production cycle while growing the highest quality and healthiest plants in an optimum, consistent environment unaffected by weather. The Organa Garden Systems (OGS) provide a means for food production and consumption change to global environmental and ecological sustainability through vertical hydroponics rotary farming.

 

OGNG News:

 

September 10 - Global Market Demand for Premium Organic Foods Continues

 

Organa Gardens International Inc. (OTCBB: OGNG) has a vertical hydroponic farming system known as OGS-E. The OGS-E will virtually eliminate current problems like transportation costs, pollution and product spoilage while enabling the grower/farmer to realize the same crop yield using between one-fifth to one-tenth the land currently needed depending on the crop being grown. The fully automated system recycles and reuses 95% of the water used while requiring a negligible amount of energy to run. The system uses a specially developed nutrient fertilizer which enables it to produce a higher quality of fruits and vegetables.

 

In a March 2009 report by Global Business Insights, "The organic food and drinks market grew rapidly over the first part of the decade with sales in the US and the nine largest European markets reaching $46 billion in 2007. Positive growth is expected to continue in 2009 as the demand for organic food and drinks is proving to be resilient in a number of key markets and product sectors due to a combination of key factors. Firstly, heavy purchasers of organics typically have significantly higher than average disposable incomes and have so far been largely unaffected by the global downturn. Secondly, the price differential between many organic and regular products has contracted steadily in recent years and this has increased consumer reluctance to revert to cheaper non-organic alternatives."

 

More and more people are turning to organic food as a more reliable and safer way to feed themselves and their family. Artificial ingredients used to make a product low fat or low in calories are starting to be questioned. Strange-sounding ingredients are a concern for consumers. Most consumers now recognize the fact that non-organic foods can contain pesticides, chemical fertilizers and herbicides. Food scares such as BSE and more recently Avian Flu have not only had a detrimental effect on various industries, but also awakened consumer interest in where their food actually comes from. Consumers are starting to question the trust and loyalty they have placed in the food and drinks industry to date.

 

Organa is in the process of bringing its OGS-E into commercial production and feels its gardening technology is the answer for the concerned consumer. Company president Christopher Scheive states, "Organa's reinventing the food wheel will enable consumers to grow organic goods without the risks of pesticides, crop pests, and soil borne diseases while reaping the rewards of higher yields and seasonal extension of crop growth."

 

JAGUAR MINING ENTERPRISES INCORPORATED (OTC: JAGR)

 

Detailed Quote: www.otcpicks.com/quotes/JAGR.php 

 

Company Profile: http://www.otcpicks.com/jaguar-mining/jaguar-mining.htm 

 

Jaguar Mining Enterprises, Inc. is an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in Mexico. The Company specializes in the exploitation of iron ore mines with proven reserves. The Company's strategy is to locate, acquire and develop mine locations that contain sufficient quantities of iron ore and require minimal start-up costs.

 

JAGR News:

 

September 9 - Jaguar Mining Enterprises Issues Special Letter to Shareholders

 

Jaguar Mining Enterprises, Inc. (OTC: JAGR), an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in Mexico, announced that it has issued a Special Letter to Shareholders to update existing JAGR investors on the current status of Jaguar Mining, and more importantly, its future growth outlook. Excerpts from the letter follow:

 

"Currently, our primary emphasis is to develop an iron ore reserve containing 20 million metric tons (mt) at our Cascaronal Project in Jalisco, Mexico. We have completed all necessary studies and documentation for permitting and expect commence extraction within the next 45 days. Our plans are to convert the Cascaronal Mine from pre-production to production, with the mine being brought up to full production within 120 days thereafter. Once mining operations have commenced, we believe that over 2,000 tons of iron ore can be mined daily resulting in over $4.5 million in revenues over the next fiscal year with earnings of nearly $1 million."

 

"In spite of recent market volatility, we expect that rising worldwide demand will likely produce a tight market into next year. Iron ore prices are normally set in annual talks between major suppliers and customers. As they have been unable to agree upon a benchmark price, iron ore is being sold on the open market. Prices spiked in early August, but we have seen a decline since then. The company's policy of strict fiscal discipline and cost control will help us weather these up and down prices we're now seeing, and allow us to be profitable as we move forward."

 

The full shareholder letter can be viewed on Jaguar Mining's website at www.jaguarminingenterprises.com.

 

FOUNTAIN HEALTHY AGING INCORPORATED (OTCBB: FHAI)

"Up 35.14% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/FHAI.php 

 

Fountain Healthy Aging is a company specifically focussed in the anti aging industry, which is one of the quickest growing industry sectors worldwide. We have a range of products targeted at the anti-aging market, including our revolutionary flagship product Vitalife, which we believe is ready to make a massive impact in the anti-aging industry. We recognize the importance of the anti-aging sector, an emerging dynamic within the overall health and wellness revolution. We believe that we are uniquely positioned to capitalize on this rapidly growing trend, first with our unique flagship product, rapidly followed by our other products which have been specifically developed for this market. Fountain Healthy Aging's main focus is on the specialty, premium product category, which is a growing segment of the market that provides gross margins significantly higher that the lower-priced, mainstream health products market.

 

FHAI News:

 

August 12 - Fountain Healthy Aging Inc Announces $5,000,000 Equity Line Of Credit Investment Secured

 

Fountain Healthy Aging Inc. (OTCBB: FHAI) announced on August 12 2009 that it had entered into an agreement with Dunn Capital Partners and Oak Resources Limited which provides the Company with a $5,000,000 Equity Line of Credit investment. Under the terms of the agreement, Fountain has the right to draw down from the Equity Line Investment in tranches of up to $1,000,000 each, for a term of 24 months. The first tranche investment of $1,000,000 was drawn down by Fountain on August 10 2009.

 

Fountain CEO, Paul Hunston, said "We are very pleased to have secured this $5,000,000 equity line of credit, which will enable us to fully implement our business plan and accelerate the Company's growth both within the US and internationally. This is great news for both Fountain and its shareholders."

 

Michael Bailey, head of Equity Capital markets at Dunn Capital Partners said: "We take pride in our ability to identify companies with strong management teams, growth potential and competitive advantages. We are delighted that through Oak Resources, we have been able to make this investment in Fountain. We think Fountain is perfectly positioned to leverage its high quality and natural product range and take advantage of its unique positioning in the market place. We look forward to working with Oak Resources and Fountain in helping the Company realize and execute its full growth potential."

 

ABOUT DUNN CAPITAL PARTNERS

 

Dunn Capital Partners is a private investment company and is focused on investing in growing Small Cap issuers with solid fundamentals.

 

Dunn Capital Partners typically invests anywhere from $10,000,000 to $250,000,000+ with companies seeking a long-term funding partner and a strategic partner to support its growth.

 

Dunn Capital Partners is committed to investing in companies with strong management who have the ability to execute their business plan upon the receipt of growth capital.

 

Dunn Capital Partners is industry and geography agnostic.

 

BIOELECTRONICS CORPORATION (OTC: BIEL)

"Up 16.42% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/BIEL.php

 

BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast™ Therapy (www.healfasttherapy.com) and the Allay™ family of inexpensive, disposable drug-free anti-inflammatory devices.

 

BIEL News:

 

September 8 - A New Audio Interview with Andrew Whelan, CEO of BioElectronics, Inc., is now at SmallCapVoice.com

 

SmallCapVoice.com, Inc. announced that a new audio interview with BioElectronics Corp. (OTC: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices is now available. The interview can be heard at http://smallcapvoice.com/blog/9-4-09-audio-interview-with-bioelectronics-corporation-otcpk-biel. In the interview, CEO, Andrew Whelan, discusses the Company’s schedule for FDA applications for its drug-free anti-inflammatory devices and reiterates his confidence relative to FDA OTC clearances.

 

VERIFY SMART CORPORATION (OTCBB: VSMR)

"Up 15.63% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/VSMR.php

 

VerifySmart Corp. designed and developed a Proprietary Hardware/Software Solution that solves Credit/Debit Card fraud by using two Factor Authentication. The Company's Core Technology is designed to meet the needs of the Security challenged Trans action Processing Industry. Present day solutions, such as Verified by Visa, Chip and Pin and CVV Code (all which can be compromised) have not reduced payment card fraud by any significant factor. The VerifySmart solution has reduced fraud to zero in earlier production pilots. The Company's proven and highly scalable solution is gaining worldwide attention and placing VerifySmart at the forefront of the fraud prevention revolution.

 

VSMR News:

 

September 10 - VerifySmart™ Corp. targets Asia Pacific region; Initiates card fraud prevention dialogue with several of Asia's largest Banks

 

VerifySmart™ Corp. (VSMR: OTCBB) ("VerifySmart" or the "Company"), a global leader in secure and fraud free payment credit and debit card processing services, announced that Mr. Adi Muljo, Senior Vice President of Business Development - Asia Pacific Region will initiate senior level discussions with representatives of several of the largest Banks serving the Asia Pacific region.

 

"The Asian Pacific Market represents a huge client opportunity for the VerifySmart™ Corporation and its portfolio of financial and technology service applications," says Mr. Muljo. "Our initial discussions have generated a lot of excitement as to the application and expansion of our technology. The need for security and payment authorization authentication in the expanding e-commerce market place cannot be overstated and this represents a significant opportunity for VerifySmart's credit and debit card transaction security technology."

 

China is one of the world's largest e-commerce markets, along with the United States, Germany, UK, Japan and even India, with its burgeoning middle-class consumer population. Central and south Asian tech-savvy online shoppers currently buy everything from furniture and flowers to airline tickets and iPods, and sector growth is explosive.

 

E-commerce is growing at a rate exceeding 20 percent per year with some Asian markets growing as much as 40 percent annually. Amazon.com and eBay are among the most popular sites in Asia, facilitating millions of online transactions valued at hundreds of millions of dollars daily. The market research firm Euromonitor International forecasts Internet retail sales in the Asia-Pacific region will reach more than $71 billion by 2012, almost doubling numbers posted for 2007.

 

As ID theft and Credit/Debit card fraud surpassed $56 Billion annually, the need for secure payment authentication grows exponentially. VerifySmart™ technology adds a new layer of security to existing protocols, by notifying the cardholder of each and every purchase through the card holder's own cellular phone, thus enabling the cardholder to approve or decline his or her purchase via a secure PIN (personal identification number)

 

The resulting transaction represents to the merchant, to the underlying financial institution or credit provider, and to the card holder, an undisputed guarantee of acceptance. VerifySmart's new technology is a first in the industry and, if marketplace interest to date is any indication of the near-term need for a multi-billion dollar problem, then the Company should expect favourable response from potential partners.

 

"VerifySmart™ has the right product at the right time. We expect an impressive transaction growth rate, especially in this world of technology convergence," concludes Mr. Muljo. A new report from Portio Research predicts that half of the world's population currently have mobile devices, and further that over the next couple years, global penetration will reach 75 percent.

 

ABOUT MR. ADI MULJO

 

Mr. Muljo holds the strategic role of Senior Vice President of Business Development in the Asia - Pacific Region with VerifySmart™ Corp. His reputation as one of the most respected and renowned corporate ambassadors in his native country of Indonesia, coupled with the reach of his successful Baltimore, MD based trade consultancy, uniquely positions him to take on this role and enhance the VSC growth plan.

 

Between 1971 and 1998, Mr. Muljo held various senior management positions with Indonesia's largest conglomerate, the Astra Group, including General Manager of its Xerox Division and Managing Director of Inter Delta, Indonesia's sole distributor for Kodak products and Canon cameras.

 

From 1981-1998, Mr. Muljo was responsible for the Vancouver and Baltimore offices of the Astra Group and was also in charge of overseeing Astra's North American expansion directed from the Baltimore office, where Mr. Muljo makes his home.

 

Mr. Muljo holds a BA in Economics and an MBA in Finance. VSC management welcomes this significant appointment which we believe will accelerate the company's growth plan and enhance shareholder value. Mr. Muljo's past successes and extensive network in the Asia/Pacific Region is invaluable to the company's pursuit of becoming the premier provider of fraud prevention solutions across the globe.

 

DISCOVERY LABS INCORPORATED (NASDAQ: DSCO)

"Up 35.42% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/DSCO.php

 

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary Capillary Aerosolization Technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children, beginning with Respiratory Distress Syndrome (RDS).

 

DSCO News:

 

September 10 - Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for SURFAXIN Approval

 

Discovery Laboratories, Inc. (Nasdaq: DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

 

At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.

 

Background

 

The April 17 Complete Response letter from the FDA and the June 2 meeting focused primarily on certain aspects of the BAT, specifically whether preclinical data generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to the to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.

 

During the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an array of quality control tests, but did not employ the BAT to evaluate biological activity of the Surfaxin clinical drug product. After completing the Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on agreements reached in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use. Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the preterm lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.

 

At the June 2 meeting with the FDA, Discovery Labs presented data from the preterm lamb model and BAT studies, together with a comprehensive statistical evaluation of such data, intended to establish the comparability of clinical drug product to Surfaxin drug product to be manufactured for commercial use. The comprehensive statistical evaluation was a comparative regression analysis using an accepted FDA statistical method. Discovery Labs believes that the data and related statistical evaluation are highly supportive of the comparability of clinical drug product to commercial Surfaxin.

 

However, the FDA stated at the June 2 meeting, that data generated from the preterm lamb model and BAT studies must demonstrate, in a point-to-point analysis, the same relative changes in respiratory compliance between both models over time. Based on this standard, Discovery Labs believes that establishment of comparability in this manner would be an extremely high hurdle and that, from the FDA's perspective, the data analysis provided by Discovery Labs did not meet that standard.

 

In addition, the FDA suggested that the comparability studies in the preterm lamb model and the BAT would not be necessary if the BAT had been implemented to assess Surfaxin drug product used in the Phase 3 clinical trials. The FDA also suggested that, to increase the likelihood of gaining Surfaxin approval and as an alternative to demonstrating comparability using the preterm lamb model and BAT, Discovery Labs could consider conducting a limited clinical trial, while simultaneously employing the BAT, as a path forward to Surfaxin approval.

 

SPEEDUS CORPORATION (NASDAQ: SPDE)

"Up 24.00% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/SPDE.php

 

Speedus Corp., through its subsidiaries, engages in healthcare, restaurant, and wireless businesses in the United States. The company has co-invested with Siemens Corporate Research, Inc., a subsidiary of Siemens Corporation, in Zargis Medical Corp. to develop advanced diagnostic decision support products and services that automatically analyze acoustical data from a patient to determine physiologically significant features useful in medical diagnosis for primary care physicians, pediatricians, cardiologists, and other healthcare professionals. It owns 90% of F&B Gudtfood, the creator and operator of the original Eurocentric cafe, which operates a store in Manhattan. The company has a portfolio of patents that provide high-speed wireless communication systems. In addition, it offers Local Multipoint Distribution Service (LMDS) license for developing and deploying LMDS technology that is used for various fixed wireless purposes, including wireless local loop telephony, high-speed Internet access, and two-way teleconferencing. The company, formerly known as SPEEDUS.COM, Inc., was founded in 1995 and is based in New York, New York.

 

SPDE News:

 

September 11 - Density Dynamics Develops Distribution; Signs International Rep Agreement

 

Density Dynamics, a majority owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced that it has signed an International Representation agreement covering India with Graphay, Inc.

 

"We are excited to establish a sales and distribution channel for the cutting-edge DRAM-based SSD's built for high speed data enterprise users. My experience at Wachovia in the data center environment led me to witness the Jet.io SSD. Its power and performance capabilities are highly anticipated in the Indian market and together with Graphay's technologies, will address pressing needs of our Enterprise customers. We look forward to a long and fruitful relationship," said Ashish Majmundar, CEO and founder of Graphay.

 

ABOUT DENSITY DYNAMICS

 

Density Dynamics, a majority owned subsidiary of Speedus Corp., is a pioneer in the solid-state storage and I/O acceleration technology. Its high performance RamFlash solid-state storage and computing devices are designed to reduce I/O bottlenecks while also reducing power, cooling, and rack space requirements.

 

ABOUT GRAPHAY

 

Graphay, headquartered in Matthews, NC, is an Enterprise IT Solutions Provider to customers in India & Israel. Graphay offers end-to-end architecture design, desktop and data center virtualization, along with best-in-breed products from its Global technology partners.

 

VIA PHARMACEUTICALS INCORPORATED (NASDAQ: VIAP)

"Up 8.37% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/VIAP.php

 

VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in the blood vessel wall, which is an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation.

 

VIAP News:

 

July 17 - VIA Pharmaceuticals Receives Anticipated Notice From NASDAQ

 

VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced that it received a Staff Determination letter, dated July 15, 2009, from the NASDAQ Stock Market stating that the Company has not regained compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing, as set forth in Listing Rule 5550(b), and that the Company's securities are, therefore, subject to delisting from The NASDAQ Capital Market.

 

The Company intends to file an appeal of the NASDAQ Staff Determination by July 22, 2009 and to request a hearing before a NASDAQ Listing Qualifications Panel (the "Panel"), which request will stay the delisting of the Company's securities pending the Panel's decision. There can be no assurance that the Panel will grant the Company's request for continued listing on The NASDAQ Capital Market.

 

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