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It's hanging real nice above $4 now. Looks like investors really liked yesterdays news. Given the potential of their other research I'd say the company has a very bright future, just a matter of getting through all the trials and proving everything works and is safe.
What's bad news for Merck tends to be good news for Abbott. I was at my Doctor's just a couple of weeks ago talking to him about these drugs. He had already gotten wind of some of this information. He said the time released Niacin has had great results lowering bad cholesterol but nobody had a big break through in raising good cholesterol, just minor successes. I'm not so sure it's such a good thing to lower cholesterol too much, there's some studies that suggest that overall cholesterol under 200 might lead to liver damage. I think some of these companys have been moving too fast on this and didn't consider long term side effects. Hopefully Abbott has all their I's dotted and T's crossed. If so they could really come out on top and grab a huge market share.
NEWS! Magellan Financing.
China Shoe Announces Agreement on US$2M Financing; Further Financing Will Fuel Expansion
SHANGHAI, China, March 24 /PRNewswire-FirstCall/ -- China Shoe Holdings (OTC Bulletin Board: CHSH) today announced that it has entered into an equity line of credit agreement ('ELC') with Magellan Global Fund, LP (Magellan) that provides China Shoe with the option to draw down up to $2 million of equity funding by Magellan at any time over a two year period commencing with the effectiveness of a registration statement to be filed by the company.
China Shoe management is pleased to point out that the terms of the financing are beneficial to the long-term growth on the company. Draw downs on the ELC will be at China Shoe's sole discretion. If China Shoes elects to make a draw under the agreement, the shares to be issued will be priced at an 8% discount to the average closing bid price of China Shoe's shares during the pricing period which is at the time of the draw with a 'floor price' of $0.07. Because there is a floor price, the company will not be subject to a 'death spiral' or other dilutive terms. In addition, there are no warrants, stock options or any type of preferred securitization, keeping the transaction simple and straight-forward.
In connection to this transaction, China Shoe has paid to Magellan a non- refundable fee of $40,000 through the issuance of an additional 571,429 restricted shares. A registration statement relating to these securities will be filed in the short future. Upon effectiveness of the registration statement, an additional fee of $40,000 will be payable to Magellan.
'We are delighted with the agreement with Magellan Global Fund. The completion of this funding will enable our continual expansion, especially on the execution of our retail strategy,' according to Mr. Gu XianZhong, Chairman and CEO of China Shoe. 'In addition, we believe the terms of the equity line of credit agreement is competitive and it provides us with excellent financial flexibility for the future while minimizing dilution to shareholders.'
About China Shoe Holdings, Inc.
Based in Shanghai, China, China Shoe manufactures, designs and sells private label and its own branded footwear throughout China and in overseas markets, principally Japan. China Shoe has its own manufacturing facilities located in China. China Shoe has built a diversified customer base throughout China and overseas.
About Magellan Global Fund, LP
Managed by Orinda Advisers LLC, Magellan Global Fund, LP is a U.S.-based private equity fund with a global partnership outlook. A key player in structuring and executing early stage investments for both private and public companies in China, India and Emerging Europe. For more information please visit: www.magellanglobalfund.com.
SOURCE China Shoe Holdings, Inc.
Almost a 10 percent gain in a week. Things are looking up.
What's everyone's opinion on the stock now? We've had a slow down tick but no sign of dilution. Do you feel you are "long and strong" in this waiting for the major breaking news and willing to wait 12-24 more months or are you hoping for a sharp upswing with the next clinical trials or possibly a buy out offer? I'm curious to see where most people stand on this.
Price is starting to creep back up. I think the concern over the auditors was overblown. The main value of this company is it's future potential with the anticipated TRT contracts, not it's financial past which admittedly isn't much since they've just gotten started.
Pluristem Submits Pre-IND Application in Germany to Initiate Clinical Trials of PLX-PAD for Peripheral Artery Disease
Pluristem Therapeutics, Inc. (NASDAQ:PSTI) announced today that it has filed a Pre-Investigational New Drug (Pre-IND) application with the Paul Ehrlich Institute (PEI) in Germany for PLX-PAD, the Company’s product for the treatment of Peripheral Artery Disease. The PEI is the German federal authority granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX™ technology.
Pluristem has submitted a scientific package to the PEI. The package contains the results of a proof of concept study and preclinical study synopses utilizing PLX-PAD to support an IMPD (Investigational Medicinal Product Dossier) submission planned for later this year. This Pre-IND document also contains information concerning the process used to manufacture Pluristem’s PLX-PAD product and the proposed clinical trial supporting the Company’s IMPD.
Zami Aberman, Pluristem’s President & CEO, stated: “I am proud that our team has accomplished this important milestone in submitting this Pre-IND document as planned. I believe it represents the Pluristem team’s ability and devotion to successfully meet the Company’s goal of building a pipeline of PLX products, leading the Company to future achievements and prosperity."
About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from the human placenta, a non-controversial source, and not from embryonic stem cells.
The placental cells are expanded in the Company’s proprietary PluriX™ 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors, or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent, and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to their secretion of cytokines or other potent immune modulators. Furthermore, the PLX cells are immune-privileged and immunosuppressive, hence protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem’s PLX-PAD is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). Pluristem has previously announced its PLX cells can be therapeutically beneficial in the treatment of a variety of other indications, such as ischemic stroke and Parkinson’s disease (PD).
The Company’s PLX-I is intended to resolve the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood (UCB).
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, when we discuss our team ability to successfully meet the Company’s goal of building a pipeline of PLX products, leading the Company to future achievements and prosperity, we are using a forward looking statement. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risk and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
The resent PPS drop of almost $10 per share since mid January appears to be due in part to reaction to the economy and in part to several insiders selling shares. Of course the CEO selling $9 million worth of shares raises an eyebrow until you consider that he has well over $100 million worth of shares to sell. I figure he just wants to take advantage of the cheap housing market and buy himself another mansion.
Thanks Max, I'm considering it. It appears that most shareholders have chosen to wait and see what the revised filings say. A few or possibly one shareholder has dumped at the market price bringing down the PPS. Good opportunity for someone who wants to get in cheap.
Lung Cancer Treatment News:
Abbott to Collaborate With Genentech, Roche and OSI on Molecular Test for Lung Cancer Therapy Response
Abbott's FISH Technology Provides Analytical Tool with Potential to Assess Clinical Response to Lung Cancer Treatment in Patients with Non-Small-Cell Lung Cancer
DES PLAINES, Ill., March 7 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced that its molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals, Inc. to develop a gene test to potentially assess the clinical benefit of Tarceva(R) (erlotinib), an oral tablet indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its proprietary fluorescence in situ hybridization (FISH) technology in NSCLC. Financial terms of the agreement were not disclosed.
Currently, there are no nucleic acid based tests validated or approved by the U.S. Food and Drug Administration that could identify patients who may derive greater treatment benefits from targeted lung cancer therapies.
'By helping to unlock the information found at the molecular level in each person's DNA, we believe that molecular diagnostics hold the promise of personalized medicine,' said Stafford O'Kelly, vice president, molecular diagnostics, Abbott. 'Our goal through this important technology is to improve the practice of medicine by helping to reduce risk, produce targeted cures, and improve the detection and prevention of serious illnesses.'
Tarceva Safety
There have been infrequent reports of interstitial lung disease (ILD)-like events, including fatalities in patients receiving Tarceva. While receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. The most common side effects in patients with NSCLC receiving Tarceva were rash and diarrhea. For more information on Tarceva, including the full prescribing information, please visit http://www.Tarceva.com.
About FISH
FISH technology provides the ability to see multiple chromosomal abnormalities simultaneously in a single cell and to visually assess these genetic abnormalities in patient specimens. FISH-based tests use DNA probes labeled with colored fluorescent tags that bind to specific gene sequences on human chromosomes. These probes can reveal amplification of gene copy number or the rearrangement of large genetic structures, two genetic abnormalities that underlie certain cancers and other medical conditions.
About Abbott Molecular
Abbott's molecular diagnostics business, headquartered in Des Plaines, Ill., provides physicians with critical information based on the early detection of pathogens and subtle, but key changes in patients' genes and chromosomes, allowing for earlier diagnosis, selection of appropriate therapies and monitoring of disease progression.
The business includes instruments and reagents used to conduct sophisticated analysis of patient DNA and RNA.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
Someone's been slowly accumulating under the radar. Makes me think they know something's up.
Looks like the information from the old accountants is suspect and the company is trying to be honest and restate the 2006 financial statements. Investors are not liking this surprise and driving the price down.
From the statement:
China Recycling Energy Corporation ("Company") concluded on March 05, 2008 and announced on March 05, 2008 that it would restate its financial statement for fiscal year ended December 31, 2006, contained in the Form 10-KSB annual report filed on April 13, 2007.
Accordingly, the Company's prior Form 10-KSB Annual Report for Fiscal Year ended December 31, 2006 should no longer be relied upon.
The decision to restate the Company's financial statements was made by the Board of Directors on March 5, 2008, following consultation with, and upon the recommendation of, management. The Company has discussed the need to restate the previously issued financial statements and the matters disclosed in this filing with Zhong Yi (Hong Kong) C.P.A. Company Limited ("Zhong Yi"), the Company's independent registered public accounting firm, and Zhong Yi has concurred with the decision of the Board to proceed with the restatement. The Company's decision to restate was made in connection with a review of the Company's most recent Form 10-KSB by the Corporation Finance Division of the U.S. Securities and Exchange Commission (SEC).
The restatement will include changes to the impairment loss from Company's operations.
While the information contained herein describes all of the items for which the Company and Zhong Yi have determined a restatement is appropriate at this time, there can be no assurance that further review and inquiry of the Company's financial statements will not identify additional items.
Forward Looking Statements
Statements contained in this Form 8-K relating to the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future, including statements with the words "expects", "will", "intends" and "may" and statements relating to its expected adjustments to previously reported financial results, are forward-looking statements. The Company's actual results, including the items and amounts actually restated, and the timing of the completion of the restatement and related audit, could differ materially from those projected in these forward-looking statements. The actual items and amounts restated, and the actual timing of completion of the restatement and related audit, will depend on a number of factors, including any additional discussions with the SEC, the completion of the work underlying the restatement by the Company and the audit and review of the underlying work and restated financial statements by Zhong Yi. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings. The Company disclaims any intention or obligation to revise any forward-looking statements, including financial estimates, whether as a result of new information, future events or otherwise.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
China Recycling Energy Corporation
Date: March 5, 2008
/s/Guangyu Wu
Guangyu Wu
Chief Executive Officer
I've been watching for signs of dilution and can't find any. It looks like they are being honest about trying to keep up the share value. This could be a gold mine in a couple more years, a good entry point for someone holding long.
FYI they amended the 8-K. Bottom line is they dismissed the previous independent auditor and replaced him with another one.
ITEM 4.01 CHANGES IN REGISTRANT'S CERTIFYING ACCOUNTANT.
On September 6, 2007, the board of directors of China Shoe Holdings, Inc.’s (the “Company”) recommended and approved the dismissal of its independent auditor, Chang G. Park, CPA (“Park”) of Chula Vista, California. The Board of Directors does not have an audit or any other committee.
During the Company's two (2) most recent fiscal years and any subsequent interim period preceding the resignation, the Company has had no disagreements with Park on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure.
No accountant's report on the financial statements for either of the past two (2) years contained an adverse opinion or a disclaimer of opinion or was qualified or modified as to uncertainty, audit scope or accounting principles, except for the following going concern qualification:
“The financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company's losses from operations raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.”
On September 6, 2007 the board of directors of China Shoe Holdings, Inc. also recommended and approved the appointment of Zhong Yi (Hong Kong) C.P.A. Company Limited as successor independent accountant.
On January 30, 2008, the Company provided Park with a copy of a draft of this Form 8-K amendment and requested that it furnish a letter to the Company, addressed to the Securities and Exchange Commission, stating that it agreed with the statements made herein or the reasons why it disagreed. The Company has received a copy of a letter fropm Park which is being filed as an exhibit to this amendment to this report on Form 8-K
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.-
Exhibit No. Description
16.1 Letter on change of certifying accountant pursuant to Regulation SB 304(a)(3).
--------------------------------------------------------------------------------
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: February 20, 2008
China Shoe Holdings, Inc.
By: /s/ Gu Xianzhong
--------------------------------------------------------------------------------
Name: Gu Xianzhong
Title: President
Financing Completed.
China Shoe Announces Completion of Private Equity Financing Totaling US$550,000
Completion of Financing Allows Company to Accelerate Execution of its Retail Strategy
SHANGHAI, China, Feb. 4 /PRNewswire-FirstCall/ -- China Shoe Holdings Inc. (OTC Bulletin Board: CHSH), announced today that it has completed a US $550K private placement of its restricted common stock. On January 30 2008, the Company completed its first round of private equity financing since going public (commonly referred to as a 'PIPE' transaction), and obtained investment funds from YU Guorui in the aggregate sum of US $550,000 for the purchase of 4,230,769 shares of the Company's restricted common stock. This represents a purchase price of $0.13 per share.
China Shoe management is pleased to point out that the PIPE financing terms negotiated are fairly priced, and are a simple stock purchase agreement with no convertible features, warrants, stock options or any type of preferred securitization. All common stock sold in this financing will bear a restrictive legend reflecting the need for a Securities Act registration or an exemption such as Rule 144, for resale. Because there is no convertible security being issued, the Company will not be subject to any 'death spiral' or other dilutive terms in this straight-forward restricted stock purchase agreement
The completion of financing will accelerate the execution of China Shoe's retail strategy and the Company now targets to have, in full operation, up to twenty self-owned stores and numerous licensed stores promoting China Shoe's own brand of Kangies footwear by July 2008.
'This PIPE financing allows the company to invest additional capital to fuel the growth of our retail strategy while maintaining the strong growth on the manufacturing side', said Gu XianZhong, Chairman and CEO of China Shoe Holdings. 'Additionally, we are very pleased to have YU Guorui as our investor as she has had extensive experience in the retail business as well as established business networks in the region, which are definitely tremendous strategic assets for the company.'
About China Shoe Holdings, Inc.
Based in Shanghai, China, China Shoe manufactures, designs and sells private label and its own branded footwear throughout China and in overseas markets, principally Japan. China Shoe has its own manufacturing facilities located in China. China Shoe has built a diversified customer base throughout China and overseas.
Safe Harbor Statement
This release may contain forward-looking statements. These forward- looking statements are neither promises nor guarantees, but involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Readers should not place undue reliance on any such forward-looking statements that are based solely on information known as of the date of this release. China Shoe Holdings, Inc. disclaims any obligation to update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statement.
GOOD NEWS!
Abbott Receives FDA Approval for HUMIRA(R) (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
HUMIRA Is the First Biologic Treatment Approved in Nine Years for Children Suffering from This Potentially Debilitating Autoimmune Disease
ABBOTT PARK, Ill., Feb. 22 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(R) (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. In the U.S., JIA is commonly referred to as juvenile rheumatoid arthritis (JRA). The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. HUMIRA is the first biologic treatment to receive FDA approval for this condition since 1999, and the first to be administered by injection in these patients once every two weeks.
'The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play or participate in other activities with children their age,' said Daniel J. Lovell, M.D., M.P.H., associate director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati. 'HUMIRA is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA.'
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling. Any joint can be affected and inflammation may limit the mobility of the affected joints. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 percent of children with JIA will still have active disease into adulthood.
'The symptoms of JIA can make it difficult for children to experience many of the simple joys of childhood,' said John Hardin, M.D., chief scientific officer, Arthritis Foundation. 'The Arthritis Foundation welcomes the approval of new therapies that expand effective treatment options for doctors and families, helping children and adolescents to keep their symptoms under control.'
JIA is the sixth disease indication for which HUMIRA has received approval since 2002.
HUMIRA JIA Clinical Study
The approval is based on the results of a 48-week study and a subsequent open-label extension evaluating the efficacy and safety of HUMIRA. In the 48-week study, fewer children treated with HUMIRA experienced disease flare compared to placebo. Overall, children on HUMIRA experienced improvements in their disease symptoms.
The 48-week Phase III study included 171 children (four to 17 years of age) with polyarticular JIA, a form of arthritis affecting five or more joints, usually the same joints on both sides of the body.
In the first part of this study, two groups of patients -- those taking methotrexate (MTX) and those not taking MTX -- received open-label HUMIRA (up to a maximum of 40 mg) every other week for 16 weeks. Patient responses were measured using the American College of Rheumatology Pediatric (ACR Pedi) 30 score, which represents a 30 percent or greater improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. Children who showed a positive clinical response (n=133) entered the second part of the study and were randomized to receive HUMIRA or placebo for an additional 32 weeks or until disease flare. A flare was defined as a worsening of 30 percent or more in at least three of the six ACR Pedi response variables, a minimum of two active joints, and no more than one indicator improving by 30 percent.
In the second part of this study, significantly fewer children receiving HUMIRA demonstrated disease flare compared to children on placebo, both without MTX (43 percent vs. 71 percent) and with MTX (37 percent vs. 65 percent). Additionally, more patients treated with HUMIRA continued to show ACR Pedi 30/50/70 responses at week 48 compared to placebo.
At the conclusion of the 48-week study or at the time of disease flare during the double-blind phase, patients could enter the open-label extension period. Efficacy and safety were assessed at routine intervals throughout the study. ACR Pedi responses were maintained for up to two years in patients who received HUMIRA throughout the study.
Upon initiation of treatment with HUMIRA, the most common adverse reactions that occurred were injection site pain and injection site reaction (19 percent and 16 percent, respectively).
'The approval of HUMIRA provides an excellent option in the treatment of JIA,' said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. 'In addition to its efficacy in reducing the signs and symptoms of polyarticular JIA, we believe that children and their caretakers will appreciate the benefit of convenient every-other-week dosing that HUMIRA offers.'
HUMIRA is administered at home via an injection every other week. JIA patients who weigh 30 kilograms (66 pounds) or more will use the same 40 mg HUMIRA Pen or pre-filled syringe currently used by adult HUMIRA patients. Children who weigh at least 15 kilograms (33 pounds), but less than 30 kilograms, will receive HUMIRA via a 20 mg pre-filled syringe manufactured exclusively for JIA patients.
Important Safety
Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Infections have also been reported in patients receiving HUMIRA alone. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended and patients using HUMIRA should not receive live vaccines.
More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately three-fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known. TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.
In the placebo-controlled clinical studies of adult patients with rheumatoid arthritis, the most frequent adverse reactions vs. placebo were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn's disease and plaque psoriasis, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis. In the placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3 percent in HUMIRA-treated patients versus 1 percent in controls.
In general, adverse reactions in pediatric patients were similar in frequency and type to those seen in adult patients. Severe adverse reactions reported in the clinical trial in JIA included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia and appendicitis. Serious infections were observed in 4 percent of patients within approximately two years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster. Safety of HUMIRA in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.
As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
About HUMIRA
In addition to its approval for polyarticular JIA, HUMIRA is also approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural joint damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA is also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is indicated for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-.), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases.
To date, HUMIRA has been approved in 72 countries and more than 250,000 patients worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases.
More information about HUMIRA, including full prescribing information and Medication Guide, is available on the Web site www.humira.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
SIMCOR could be another blockbuster drug. With all the problems Lipitor has been having this could really take off.
NEWS:
Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
SIMCOR Is a New Single-Pill Combination of Two Proven Therapies that Significantly Raises HDL 'Good' Cholesterol and Lowers LDL 'Bad' Cholesterol
ABBOTT PARK, Ill., Feb. 15 /PRNewswire-FirstCall/ -- Today, Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL 'bad' cholesterol and triglycerides, and to raise HDL 'good' cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
'Managing cholesterol encompasses many factors, not just lowering LDL. There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol,' said Christie Ballantyne, M.D., the Methodist DeBakey Heart and Vascular Center, Houston, and lead SIMCOR investigator. 'SIMCOR represents an important new option to help patients reach healthy lipid levels.'
An estimated 80 million Americans have high levels of the bad LDL cholesterol, and more than 44 million have low levels of the good HDL cholesterol, which the body uses to remove bad cholesterol from the bloodstream. Studies have shown that along with diet, SIMCOR can help patients with lipid disorders reach their treatment goals by addressing more than just bad cholesterol, targeting multiple lipids with one pill.
The FDA's approval was based on SIMCOR safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST clinical trial, patients receiving SIMCOR 1000/20mg achieved significant cholesterol improvements over and above what simvastatin 20mg alone provided. Patients treated with SIMCOR 1000/20mg had additional lipid improvements beyond simvastatin 20-mg treated baseline, with additional LDL reductions of 12 percent and an additional 21 percent HDL increase compared to a 7 percent decrease in LDL and an 8 percent increase in HDL with simvastatin 20mg alone. Furthermore, SIMCOR reduced triglycerides by an additional 27 percent compared to 15 percent with simvastatin 20mg alone.
SIMCOR was generally well tolerated by patients in clinical studies. Six percent of patients discontinued therapy due to flushing, the most commonly reported side effect of SIMCOR and niacin-based therapies. Flushing can be minimized by taking aspirin or an NSAID 30 minutes prior to taking the medication at bedtime. Flushing may subside over several weeks of consistent SIMCOR use.
'With SIMCOR, doctors now have a new option for helping patients reach their LDL and HDL cholesterol treatment goals with a combination of two proven therapies,' said Eugene Sun, M.D., vice president of Global Clinical Development for Abbott. 'Abbott is committed to bringing forward new cholesterol therapies, and SIMCOR represents a new treatment option for patients in Abbott's rapidly expanding portfolio of cholesterol treatments for lipid disorders.'
The American Heart Association, National Cholesterol Education Program (NCEP) and American College of Cardiology recommend more aggressive treatment of HDL to reduce cardiovascular risk. Cholesterol and other lipids can build up in the bloodstream forming plaque and restricting blood flow, which can lead to heart disease. According to NCEP guidelines, a reduction in LDL of 1 percent is associated with a 1 percent reduction in heart disease risk. Additionally, raising HDL by 1 point is associated with a 2 percent heart disease risk reduction.
Abbott is committed to the continued research of its products and has sponsored the National Heart Lung and Blood Institute's AIM-HIGH outcomes study. The study is designed to evaluate the effects of niacin extended- release and simvastatin in reducing cardiovascular events in patients with existing heart disease. AIM-HIGH began enrolling patients in 2005 with final results expected to be reported in 2011.
SIMCOR Indications
SIMCOR is the combination of two cholesterol-lowering medications: niacin extended-release (Niaspan(R)) and simvastatin. SIMCOR is used along with diet to lower levels of total cholesterol, LDL 'bad' cholesterol and triglycerides, and to increase HDL 'good' cholesterol. SIMCOR is used when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate, and when diet and other non-drug measures alone have not been successful. Patients should stay on a diet low in saturated fat and cholesterol while taking this medicine. No additional benefit of SIMCOR on heart disease over and above that shown for niacin alone and simvastatin alone has been demonstrated.
Important Safety Information About SIMCOR
SIMCOR should not be used by people with liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing; and in people allergic to any product ingredient. Patients should contact their health care provider if symptoms of unexplained muscle pain, tenderness, or weakness occur, as this may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred. Health care provider should be informed about any other medications, vitamins, or nutritional supplements people are taking to avoid possible serious drug interactions. SIMCOR should not be substituted for equivalent doses of immediate-release niacin. Liver damage has been reported when substituting sustained-release niacin products with immediate-release niacin at equivalent doses. Always check with a health care provider before changing medication. SIMCOR should be used with caution by patients who consume large amounts of alcohol. Health care providers may do simple blood tests before and during treatment with SIMCOR to check for liver problems.
SIMCOR may cause an increase in blood sugar levels. Patients with diabetes should report any changes in blood sugar levels to their health care provider. Women of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR. Flushing (warmth, redness, itching, and/or tingling of the skin) is the most common side effect and may become less frequent over time. Additional symptoms may include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling. Flushing may vary in severity and is more likely to occur when starting therapy or during dose increases. By taking SIMCOR at bedtime, flushing will most likely occur during sleep. If awakened by flushing, patients should take their time getting up, especially if feeling dizzy, faint, or taking blood pressure medications. Other common side effects may include headache, itching, nausea, back pain, and diarrhea. More information about SIMCOR, including full prescribing information, is available on the Web site http://www.rxabbott.com/pdf/simcor_pi.pdf, or by calling Abbott Medical Information at 1-800-633-9110.
About Niaspan
Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
Niaspan Indications
Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL- C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction. In patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important Safety Information About Niaspan
Niaspan is contraindicated in patients with allergies to any of its
ingredients, active peptic ulcer disease, significant or unexplained
persistent liver dysfunction, or arterial bleeding. Niaspan should not be
substituted for equivalent doses of immediate-release niacin. Niaspan should
be prescribed with caution in patients who consume substantial amounts of
alcohol and/or have a past history of liver disease. Liver function tests
should be performed on all patients during therapy with Niaspan. Use of
Niaspan with other lipid-altering medications called statins may increase the
risk of rhabdomyolysis, a rare condition that causes muscles to breakdown.
The most common side effect with Niaspan is flushing of the skin. Patients
with diabetes should carefully monitor their blood sugar and report changes to
their doctor. Other commonly reported side effects include indigestion,
headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose,
vomiting and rash. More information about Niaspan, including full prescribing
information, is available on the Web sites
http://www.rxabbott.com/pdf/niaspan.pdf and http://www.niaspan.com, or by
calling Abbott Medical Information at
1-800-633-9110.
Important Safety Information About Simvastatin
Simvastatin is a prescription tablet and isn't right for everyone, including women who are nursing or pregnant or who may become pregnant, and anyone with liver problems. Unexplained muscle pain or weakness could be a sign of rhabdomyolysis, a rare but serious side effect and should be reported to a doctor right away. Simvastatin may interact with certain foods or other medicines including lipid-lowering medications called fibrates or niacin, increasing the risk of getting this serious side effect. Patients should tell their doctor about any other medications they are taking. The most common side effects are headache, abdominal pain, and constipation.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Excellent! Music to my ears.
Not sure of the details of the deal they struck. M. Anthony was confident there was no activity for the shell in the last 13 months. Based on what I've dug up I think the former company went private rather than go to pink sheets. There's no information on Pink Sheets and no report filed after 4/2000. I also can't find anything current on the business they had going in 2000 so I suspect they've closed up shop.
Welcome Dollar Bill! I've done a lot of research on the former company, mainly to determine share structure and liabilities, but I ran across all the deals they had for the cards, H2O2000, and military stuff. It seems to me that the former company got caught up in the rule changes at the time (2000) as to what was a fully reporting company and what was a pink. They were given an "E" for being late in their reporting under the new rules and filed their last SEC document in Apr 2000. I found some share structure info from July 2000 which is listed in the I-Box but have found no mention of anything since. This is a shell now and one with a low O/S and float which reduces the chance of a R/S once it's got a merger candidate. With Michael Anthony at the helm this has the potential to do something big but it will take time for them to make certain the shell is clean and find a good reverse merger candidate. If you have any information or receive any shareholder updates please let us know.
You too max! I have a feeling this year will be a very good year for us.
This was a nice way to end the year. Glad I added while it was low. Here's to a bright and profitable future. Happy New Year fellow KINGers!
Well it looks like the end of year tax writeoffs are over. I was surprised the PPS dropped so low considering it's been between .005 and .02 for the last ten months but I guess someone needed it for their taxes. The low float and low volume makes this one move fast when something happens. When Michael Anthony files on this one it's going to explode from these levels. I hope Michael keeps this fully reporting, that'll be a big extra with this low float.
Thanks sugar61. I figure with this low float and O/S there's no chance of a R/S. Some of Michael Anthony shells have done really well. With no information, just Michael's name attached to it, this should be trading at least .10. Could be another FNCK. I think they reached $3.70 after the R/M.
The Silver Star Intl Inc apparently went out of business years ago. Michael Anthony appears to be working on reactivating it (see I-Box). From the information below the float is very low, just over 5 million with an o/s of 11.3 million.
http://www.cybermediamarketing.com/silverstar/investors.asp?m=4
Company Information
Stock Symbol: SVSR
Number of Shares Authorized: 50,000,000
Number of Shares Issues & Outstanding: 11,329,952*
Public Float: 5,141,540*
Highest Trading Price: $ 5.75 per Share
Lowest Trading Price: $ .03 per Share
Number of Shareholder: 1500+ (Estimated)**
* As Of : June 30, 2000
** Source - ADP Proxy Services NOBO List (July 10, 2000); Stock Transfer Agent Monthly Report (June 2000)
Agreed. Pluristem needs to step up to the plate and show if they were serious about uplisting.
Sorry it took so long to get back. M for a thousand, MM for a million. They insist it's a common practice in accounting.
Long shot here but my company's accountants use "m" to mean thousand. Might be the explanation.
Excellent!!! Progressing nicely.
I believe we will soon. The real payoff will be when they get the plants running over in Asia and India. I've been researching and found that back in the '80s when they expanding their nutritional line (baby formula, senior's drinks) their stock doubled very quickly and they had several forward splits late 80s early 90s. Here's hoping they do the same now.
Nice one.
Looks like Pluristem is finally serious about going after those institutional dollars. This could get exciting.
Looks like we had a nice 30% retraction on low volume and now we're headed back up, again on low volume. It appears that the float is very small here.
I agree. That's the most likely scenario.
My WAG 11-26-2007 at 9:38 pm.
This helps explain the rise in PPS.
Meant to highlight this earlier. Just showing that they're connected to some type of iron works or mill.
On February 1, 2007, the Company's subsidiary, TCH, entered into a TRT Project
Joint-Operation Agreement ("Joint-Operation Agreement") with Xi'an Yingfeng
Science and Technology Co., Ltd. ("Yingfeng"). Yingfeng is a joint stock company
registered in Xi'an, Shaanxi Province, the PRC, and engages in the business of
designing, installing, and operating TRT systems and sales of other renewable
energy products.
Under the Joint-Operation Agreement, TCH and Yingfeng jointly operate a top gas
recovery turbine project ("Project") which is to design, construct, install and
operate a TRT system in Xingtai Iron and Steel Company, Ltd. ("Xingtai"). This
project was originally initiated by a Contract to Design and Construct TRT
System ("Project Contract") entered into between Yingfeng and Xingtai on
September 26, 2006. TCH provides various forms of investments and properties
into the Project including cash, hardware, software, equipments, major
components and devices. In return, TCH becomes entitled to all the rights,
titles, benefits and interests that Yingfeng originally had under the Project
Contract, including but not limited to the cash payment made by Xingtai on
regular basis and other property rights and interests.
Yes, that's great. I'm still going thru a ton of info and I find I have to correct a previous message. At least one of their current TRT's is connected with a steel mill. (see below). I'm trying to find out in general how profitable TRT's are but I don't have much free time with the holidays coming up. I found a coal TRT plant in China that costs less than $7 million to operate and generates $24 million in profits but I haven't found a TRT like ours yet. Still, quite a profit margin.
On February 1, 2007, the Company's subsidiary, TCH, entered into a TRT Project
Joint-Operation Agreement ("Joint-Operation Agreement") with Xi'an Yingfeng
Science and Technology Co., Ltd. ("Yingfeng"). Yingfeng is a joint stock company
registered in Xi'an, Shaanxi Province, the PRC, and engages in the business of
designing, installing, and operating TRT systems and sales of other renewable
energy products.
Under the Joint-Operation Agreement, TCH and Yingfeng jointly operate a top gas
recovery turbine project ("Project") which is to design, construct, install and
operate a TRT system in Xingtai Iron and Steel Company, Ltd. ("Xingtai"). This
project was originally initiated by a Contract to Design and Construct TRT
System ("Project Contract") entered into between Yingfeng and Xingtai on
September 26, 2006. TCH provides various forms of investments and properties
into the Project including cash, hardware, software, equipments, major
components and devices. In return, TCH becomes entitled to all the rights,
titles, benefits and interests that Yingfeng originally had under the Project
Contract, including but not limited to the cash payment made by Xingtai on
regular basis and other property rights and interests.
This project is a little different than ours, it's connected to a steel mill. The Japanese have been doing this successfully for years. Notice this one plant is expected to generate 160 gigawatts of electricity. At the same time it's helping to reduce emissions. I heard on the radio that China is "going green" and would agree to meet international emission standards by 2012 if we give them the technology. I'm certain TRT's are going to be a big part of their plan in reducing emissions.