WEST, ALXA, XDSL, ACLP, HRDN, PWRM
Our Stocks to Watch tomorrow include Westinghouse Solar Inc. (NASDAQ: WEST), Alexza Pharmaceuticals Inc. (NASDAQ: ALXA), mPhase Technologies Inc. (OTCBB: XDSL), AccelPath Inc. (OTCBB: ACLP), DC Brands International Inc. (OTC: HRDN) and Power3 Medical Products Inc. (OTCBB: PWRM).
WESTINGHOUSE SOLAR INCORPORATED (NASDAQ: WEST)
"Up 21.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/WEST.php
Westinghouse Solar is a designer and manufacturer of solar power systems. In 2007, Westinghouse Solar pioneered the concept of integrating the racking, wiring and grounding directly into the solar panel. This revolutionary solar panel, originally branded "Andalay", quickly won industry acclaim. In 2009, the company again broke new ground with the first integrated AC solar panel, reducing the number of components for a rooftop solar installation by approximately 80 percent and lowering labor costs by approximately 50 percent. This first AC panel, which won the 2009 Popular Mechanics Breakthrough Award, has become the industry's most widely installed AC solar panel. Award-winning Westinghouse Solar Power Systems provide the best combination of safety, performance and reliability, while backed by the proven quality of the Westinghouse name.
June 21 - Westinghouse Solar Granted Continued NASDAQ Listing
Westinghouse Solar, Inc. (NASDAQ: WEST), a designer and manufacturer of solar power systems, announced that it has been granted continued listing on NASDAQ.
On June 19, 2012, the Company received a letter from The NASDAQ Stock Market notifying the Company that a NASDAQ Hearings Panel (the "Panel") granted the Company's request for continued listing of its common stock on the NASDAQ Stock Market. The continued listing is subject to conditions including the following: on or before October 1, 2012, the Company will close the merger transaction with CBD Energy Ltd. Should events occur or information come to light that call into question whether the proposed merger will close by that date or whether CBD will qualify for listing on the NASDAQ Stock Market, the Company is to inform the Panel, which may determine at that time to delist the Company's shares if the Company is not fully in compliance with the requirements for listing.
This notification related to a hearing held on May 24, 2012. The hearing was requested by the Company to request that the Panel grant the Company additional time to regain compliance with the minimum bid price and other listing requirements.
Further information regarding this notification is included in a Current Report on Form 8-K filed by the Company on June 21, 2012.
ALEXZA PHARMACEUTICALS INCORPORATED (NASDAQ: ALXA)
"Up 23.72% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ALXA.php
Alexza Pharmaceuticals, Inc., a development stage company, focuses on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Its product candidates are based on a proprietary technology, the Staccato system that vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. The company’s clinical-stage product candidates comprise AZ-004 (staccato loxapine), which is licensed to Biovail Laboratories International SRL for the acute treatment of agitation in patients with schizophrenia or bipolar disorder; AZ-007 (staccato zaleplon), which completed phase I status for the treatment of insomnia; and AZ-001 (staccato prochlorperazine) and AZ-104 (staccato loxapine, low-dose), phase II product candidates for the treatment of migraine headache. It also develops AZ-002 (Staccato alprazolam), which completed a phase 1 clinical trial in healthy subjects and a phase 2a proof-of-concept clinical trial in panic disorder patients for the treatment of panic attacks; and AZ-003 (Staccato fentanyl) that completed phase 1 clinical trial for the treatment of patients with acute pain, including patients with breakthrough cancer pain and postoperative patients with acute pain episodes. The company was formerly known as Alexza Molecular Delivery Corporation and changed its name to Alexza Pharmaceuticals, Inc. in July 2005. Alexza Pharmaceuticals, Inc. was founded in 2000 and is based in Mountain View, California.
June 22 - Alexza Announces Resubmission of ADASUVE™ NDA and Provides Regulatory Updates on US and EU Submissions
Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the resubmitted NDA, the classification of the resubmission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act (PDUFA) goal date will be. Class 1 and Class 2 resubmissions have targeted review periods of 2 months and 6 months, respectively.
ADASUVE NDA Regulatory Update
In May 2012, Alexza received a CRL from the FDA. In the CRL, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved." Alexza has stated that it believed the deficiencies were medical device specific and readily addressable. Since the receipt of the CRL, Alexza has received further clarification of the specific deficiencies from the FDA and has made submissions directly to Center for Devices and Radiological Health (CDRH) Office of Compliance and the San Francisco District Office, intended to fully address the deficiencies.
The May 2012 CRL also contained comments on Alexza's draft product labeling. Alexza believes that there is substantial agreement between Alexza and the FDA on product labeling. In the ADASUVE NDA resubmission, Alexza has submitted updated draft labeling which is intended to be responsive to the comments provided by FDA in the May 2012 CRL.
There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL. With respect to the ADASUVE Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the CRL has been submitted. Alexza believes that there is substantial agreement between Alexza and the FDA on the REMS.
ADASUVE MAA Regulatory Update
In March 2012, Alexza received the Committee for Medicinal Products for Human Use Consolidated List of Questions (Day 120 List of Questions) regarding Alexza's ADASUVE Marketing Authorization Application (MAA). The Day 120 List of Questions included major objections pertaining to the extrapolation of Phase 3 clinical efficacy data, aspects of the risk management plan, and the need to obtain an EU Good Manufacturing Practices certificate for Alexza's Mountain View, CA manufacturing facility and commercial manufacturing process.
In May 2012, Alexza and its corporate partner, Grupo Ferrer, met with the Rapporteur, Co-Rapporteur and European Medicines Agency (EMA) to further understand specifics of the major objections raised in the Day 120 List of Questions. Alexza believes it remains on schedule for the targeted early third quarter of 2012 submission of its responses (Day 121 Submission) to the EMA. Also in May, Alexza hosted an EU Pre-Approval Inspection (PAI) by the EMA. The inspection resulted in no findings the EMA would classify as Critical or Major findings.
MPHASE TECHNOLOGIES INCORPORATED (OTCBB: XDSL)
"Up 20.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/XDSL.php
mPhase Technologies is introducing a revolutionary Smart Surface technology enabled by breakthroughs in nanotechnology, MEMS processing and microfluidics. Our Smart Surface technology has potential applications within drug delivery systems, lab-on-a-chip analytic systems, self-cleaning systems, liquid and chemical sensor systems, and filtration systems. mPhase has pioneered its first Smart Surface enabled product, the mPhase Smart NanoBattery. In addition to the Smart Surface technology, mPhase recently introduced its first product, the mPower Emergency Illuminator, an award-winning product designed by Porsche Design Studio.
June 6 - mPhase Restructures Toxic Convertible Debt
mPhase Technologies, Inc. (OTCBB: XDSL) said negotiations with two creditors have led to a standstill agreement and restructuring of approximately $1,500,000.00 Dollars in Toxic Convertible Debentures.
The beneficial effect of restructuring of the Toxic Convertible Debentures will give the Company the control it needs to cease the automatic dilution of the issued and outstanding common stock.
The death spiral caused by these instruments has been eliminated to a large extent allowing the company breathing room to carry out its future plans.
The debt restructuring should allow the company the flexibility it needs to obtain funding for mPhase's revolutionary Smart Nano Battery Technology including the launch of its new product featuring advanced battery technology targeted for the automotive and marine industries.
The company stated: "The significant restructuring of this debt, especially the Toxic Convertible Notes, is the result of an aggressive effort on the part of management and the Board of Directors to improve mPhase's ability to meet its strategic goals of completing the commercialization of its technology and obtain funding in a more ordinary course."
ACCELPATH INCORPORATED (OTCBB: ACLP)
"Up 17.19% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ACLP.php
AccelPath provides technology solutions that play a key role in delivering information required for diagnosis of diseases and other pathologic conditions with and through its associated institutional pathologists. The medical institutions, with whom the Company partners, prepare comprehensive diagnostic reports of a patient’s condition and consult with referring physicians to help determine the most appropriate treatment. Such diagnostic reports enable the early detection of disease, allowing referring physicians to make informed and timely treatment decisions that improve their patients’ health in a cost-effective manner. The Company seeks out referring physicians and histology laboratories in need of high-quality pathology interpretations and manages HIPAA-compliant digital case delivery and reporting while developing comprehensive solutions for managing medical information.
June 11 - AccelPath, Inc. Announces Dr. Keith J. Kaplan, M.D. Continues Role as Chairman on Company’s Medical Advisory Board
AccelPath, Inc. (OTCBB: ACLP) (“AccelPath” or the “Company”) announced that Dr. Keith J. Kaplan, M.D. continues his role as Chairman and active member of the Company’s Medical Advisory Board.
Keith J. Kaplan, MD is a pathologist and Chief Information Officer (CIO) of Carolinas Pathology Group (CPG), Celligent Diagnostics and Diligent Billing and Management. As CIO, Dr. Kaplan is responsible for all aspects of informatics strategies, operations, and projects and processes that encompass laboratory, healthcare and research information systems for Carolinas Pathology Group. Prior to joining CPG, Dr. Kaplan was a surgical pathologist at Mayo Clinic, Rochester, Minnesota and also held the academic post of associate professor of pathology of Mayo Medical School.
Dr. Kaplan is a graduate of Michigan State University, a graduate of Northwestern University Feinberg School of Medicine and completed residency training in anatomic and clinical pathology at Walter Reed Army Medical Center, Washington, DC. While at Walter Reed, Dr. Kaplan was named Resident of the Year and, in conjunction with the Armed Forces Institute of Pathology, Dr. Kaplan founded and directed the Army Telepathology Program. This Program connected 25 hospitals internationally for consultation via telepathology. Dr. Kaplan also served as the Medical Director and Consulting Pathologist of Laboratory Services at Keller Army Hospital in West Point, New York.
Dr. Kaplan is board certified in anatomic and clinical pathology. His subspecialty interests include gastrointestinal and hepatic pathology, cytopathology and pathology informatics as well as research interests in gastrointestinal and hepatobiliary pathology, hyperspectral imaging, image analysis and the use of Web 2.0 tools in pathology. He has authored over 60 peer-reviewed scientific articles, book chapters, editorials and scientific abstracts and frequently lectures at both national and international meetings on topics related to pathology informatics.
Dr. Kaplan currently serves as a member of the College of American Pathologists, American Society of Clinical Pathology and the American Society of Cytopathology as well as the American Pathology Foundation. He is also an executive board member of the Digital Pathology Association. Dr. Kaplan has previously served as a member of the College of American Pathologists Informatics Committee, Standards Committee, and Instrumentation Resource Committee and as co-chair of the American Telemedicine Association Telepathology Special Interest Group.
“We are very pleased with our collaborative relationship with Dr. Kaplan,” stated Shekhar Wadekar, AccelPath’s Chairman and Chief Executive Officer. “Dr. Kaplan’s expertise in the technical and medical components of digital telepathology (through his experiences at Walter Reed Army Medical Center / the Armed Forces Institute of Pathology, founding and directing the Army Telepathology Program, and industry experience as a practicing pathologist) provides us significant insights while we enhance our proprietary digital telepathology solutions. He will also be invaluable as we further apply those to existing pathology laboratories and related service providers.”
DC BRANDS INTERNATIONAL INCORPORATED (OTC: HRDN)
"Up 100.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/HRDN.php
DC Brands International, a publicly traded company under the ticker symbol (HRDN), presently specializes in the manufacturing of its functional beverages and health products. Established in 1998, DC Brands began producing a number of lines of energy drinks in 2005. DC Brands then purchased the assets of H.A.R.D. Nutrition and began its quest to produce a new health line of products. DC Brands has recently announced the release of its new H.A.R.D. Nutrition Functional Water Systems, which it expects will revolutionize the functional beverage category.
June 14 - DC Brands International, Inc. A Leading Provider of its Functional Beverages and Health Products Announces that HARD Nutrition is Reorganizing its Business into Four Separate Groups to Focus on Nutritional Supplements and Functional Beverages to Accelerate Revenues
DC Brands International, Inc. (OTC: HRDN) announces that it has restructured the business organization of HARD Nutrition into four separate divisions; Beverages, Dry Products, Online, and Export, to more efficiently focus on accelerating revenues to the Company.
Stephen Horgan, the Company's CEO and President said, "We believe that this new strategic focus will enhance our growth and position our Company towards profitability, and ultimately shareholder value."
The business will be organized into four functional sales divisions:
* Beverage Division: encompassing HARD Nutrition's nine functional water systems.
* Dry Products Division: featuring the Company's nutritional supplements.
* Online Division: focusing on sales that originate through the HARD Nutrition website, and
* International: all product sales outside the United States.
Horgan, the Company's CEO and President who attended last week's BevNet Mid Year Conference said, "It is becoming increasingly clear to me that Functional Beverages is one of the most vibrant and promising sectors in the beverage spectrum, and that should be enhanced going into the future. I believe this sector is poised for significant and continued growth. Our main focus at BevNet was to assess the landscape for HARD Nutrition and to create distribution partnerships that will result in retail breakthroughs in specific markets, and with major retailers. It was a success in that regard, and we expect those to be completed very soon."
Horgan opined, "For HARD Nutrition to be successful going forward, it will require both a capital and commercialization strategy that work in concert to create the synergies required to maximize sales from our four newly formed business groups. These are the areas that I am personally focusing on, and is a new direction for HARD Nutrition and DC Brands. Obviously results will not be immediate, but progress is being made daily."
POWER 3 MEDICAL PRODUCTS INCORPORATED (OTCBB: PWRM)
"Up 66.67% in morning trading"
Detailed Quote: www.otcpicks.com/quotes/PWRM.php
Power3 Medical Products, Inc. a leading bio-technology company develops innovative diagnostic tests in neurodegenerative diseases (NuroPro®): Alzheimer's disease, Parkinson's disease and ALS (Lou Gehrig's disease) and cancer (BC-SeraPro™), discovers protein biomarkers and tests to detect disease, progression, drug response, and disease mechanisms, and to characterize adult stem cells.
No recent news for Power3 Medical Products, Inc. (OTCBB: PWRM).