Singh recently complete a private financing ( TERMS WERE MORE STOCK WITH SUCCESFULL PLACEMENT) that gave the company net proceeds of $21.6 million, Thus giving Lion more than two years worth of operating cash. Quogue Capital LLC was the lead investor, with several additional institutions participating, including Perceptive Advisors LLC, venBio Select Advisor, Three Arch Opportunity Fund, and Broadfin Capital LLC. “The quality of the investors participating in this financing is a strong endorsement of our clinical results to-date and of the potential for tumor-infiltrating lymphocyte technology.” Zelboraf is a highly effective treatment for melanoma patients who have a BRAF mutation, but unfortunately, patients often recur within 9 months of treatment. Thus, by combining two different treatment approaches (TILs and Zelboraf) it is possible to keep those patients in a disease free state for longer periods of time. It is this thought process of using different therapeutic approaches that Bristol-Myers, Merck, AstraZeneca, and even small companies such as Lion are attempting to perfect. BIG PARTNERS in testing Both studies are testing Cōntego conjunction with Roche's metastatic melanoma drug, vemurafenib (Zelboraf). An additional Phase I study is being tested in conjunction with Bristol-Myer Squibb's immunotherapy drug, Yervoy, and a pilot is underway with Bristol's other immunotherapy drug, nivolumab.
don't look at me I have been buying all of this, ECTI and BGMD , CDXC I can................. This is crazy. I have been in stocks that trade double their float, never like this. OPTIONS any body?
The stock will double... It has the science and it works, We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. Today, standard practice by critical care nurses is to measure blood glucose at the patient's bedside periodically. We believe that a CGM system such as Symphony will save valuable nursing time and expense by avoiding the need for frequent blood glucose sampling, in addition to providing more clinically relevant, real-time glucose level and trending information needed to develop better control algorithms for insulin administration.
Diabetes Home Use Market
Diabetes is a chronic and life-threatening disease caused by the body's inability to produce or properly use insulin, a key hormone the body uses to manage glucose, which fuels the cells in the body. Insulin regulates the uptake of sugar from the blood into the cells. When glucose builds up in the blood instead of going into cells, it can cause the cells to become starved for energy and, over time, damage the eyes, kidneys, nerves or heart. Although not all of the causes of diabetes are known, genetics and lifestyle factors such as obesity and lack of exercise appear to play important roles. According to the American Diabetes Association (ADA), about 21 million people in the United States, or approximately seven percent (7%) of the population, have diabetes, including over 6 million people who remain unaware that they have the disease. In addition, before people develop Type 2 diabetes (discussed below), they usually have "pre-diabetes," or blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes. According to the ADA, there are 54 million people in the United States who have pre-diabetes.
3 Pillars- Painless, rapid, precise skin permeation technology
• Needle-free continuous glucose monitoring device
• Needle-free, transdermal drug delivery
• Needle-Free Monitoring and Drug Delivery
• Echo is developing its Symphony® CGM System as a non-invasive, wireless, continuous glucose monitoring system for use in hospital critical care units and for people with diabetes. The Prelude® SkinPrep System, a component of our Symphony CGM System, allows for enhanced skin permeation that will enable extraction of analytes, such as glucose, and transdermal drug delivery.
-Symphony System met the primary safety and effectiveness endpoints of the trial that involved the continuous monitoring of glucose levels in 32 subjects. Investors looking at the results had to be incredibly pleased as the Symphony System had a 97.9 percent accuracy rate in its glucose readings. Additionally, there were no adverse events reported from the skin preparation or the Symphony CGM senor session. The Company's corporate objectives for the remainder of 2013 are as follows:
1. Complete the EU Regulatory Clinical Trial
2. File for CE Marking
3. Attain Food & Drug Administration (FDA) Guidance for U.S. Regulatory Pathway
4. Implement Significant Cost Reduction Initiatives- 4th quarter burn rate is expected to decrease by approximately 35-40% from the quarterly burn rate experienced during the first three quarters of 2013. Data collected from this study will serve as the basis for the CE Mark Technical File submission for marketing approval in Europe, which the Company expects to submit in the fourth quarter of 2013. Echo Therapeutics announced its intention to file for marketing approval in Europe during the fourth quarter of 2013 The Philadelphia-based company's technology is designed to help hospital personnel monitor diabetes multiple patients' blood sugar levels around the clock. It could become the De-Facto standard for the industry. Significant opportunity also exists for Symphony to be used in the hospital beyond the critical care setting, as well as in patients with diabetes in the outpatient setting. FDA- Turning now to U.S., we received comments from the FDA’s Center for Devices and Radiological Health on the pre-submission package that we filed in June of this year. Subsequent to the end of the third quarter, we met with the FDA to obtain FDA’s guidance regarding the regulatory pathway for Symphony, including feedback on our proposed pivotal trial protocol and endpoints. We may need a sample size in the range of 250 to 350 patients for the FDA pivotal trial. We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. The Prelude SkinPrep System, (painless skin permeation ) a component of our Symphony CGM System, allows for enhanced skin permeation that will enable extraction of analytes such as glucose. Prelude's platform skin preparation technology also allows for needle-free, transdermal drug delivery. The companys drug candidate is Durhalieve, an AzoneTS formulation of triamcinolone acetonide for the treatment of corticosteroid-responsive dermatoses. . It has a licensing agreement with Ferndale Pharma Group, Inc. to develop, market, sell, and distribute Prelude for skin preparation prior to the application of topical anesthetics prior to a range of needle-based medical procedures in North America and the United Kingdom; and a license agreement with Handok Pharmaceuticals Co., Ltd. to develop, market, sell, and distribute Symphony to medical facilities and diabetics in South Korea. We have had ongoing discussions regarding potential strategic partnership. Obtaining a partner or partners would allows us to leverage the partner’s exiting sales, marketing, distribution and manufacturing infrastructure while reducing the need to build up our own infrastructure. The stock is primed for news and has huge upside potential here. PIPELINE- Our Symphony CGM System is currently in development with an advanced prototype of the Symphony CGM biosensor. Echo has successfully completed numerous clinical trials with Symphony and is currently conducting a multi-center clinical trial to support a CE Mark Technical File for marketing approval in Europe.
It hasn't hit the stock screens yet! 1) When BGMD learned that they were getting only $17 per Galectin test the stock got hammered. They thought they would get $30 per test. Now they are getting the $30. They are collaborated with Kindstar Diagnostics, which is one of the largest diagnostic companies in China. Besides that huge potential, they are also in collaboration with Abbott labs with the Galectin test in the US and Europe. This stock will have good earnings next report and IMO will run back to its loftier levels. Do the DD. Look at the very low shares outstanding. This stock is extremely undervalued. 2) Major Holders:
General Electric Company
Legg Mason Capital Management, Inc.
VSR Financial Services, Inc.
Vanguard Group, Inc. (The)
BlackRock Fund Advisors
Geode Capital Management, LLC
Goldman Sachs Group, Inc.
3) Technical bounce from 9 to .5 and a huge return. They had .4 dollars in cash…….. Buying at cash levels. 4) novel cardiovascular diagnostic tests to address unmet medical needs in the United States. HUGE MARKETS EXIST FOR aid in assessing the prognosis of patients diagnosed with heart failure; and CardioSCORE test, which is designed to identify individuals at risk for cardiovascular events, such as heart attack and stroke. 5) It has license, development, and commercialization agreements with Abbott Laboratories, Alere Inc., bioMérieux SA, and Siemens Healthcare Diagnostics Inc. for the development of galectin-3 test on their automated instruments; and a strategic collaboration with Abbott Laboratories to develop and commercialize galectin-3 assay kits, and related control kits and calibrators. 6) Available in the US and Europe for individuals in the general adult population who are at risk for developing new-onset heart failure. 7) 419 heart failure patients and demonstrated that elevated levels of galectin-3 in blood, as measured using the BGM Galectin-3® Test, were significantly predictive of unplanned hospital readmissions and fatal events during the 12 month follow-up period of the trial. 8) from four hospitals and university clinics across Spain, further reported that heart failure patients with elevated galectin-3 levels had rates of hospital readmission and fatal events that were 84% higher than those of patients with lower galectin-3 levels 9) The BGM Galectin-3® Test is cleared by the U.S. FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation. DOWN 90% and safe and reliable. With over 10,000 heart failure patients in dozens of distinct clinical studies varifying results…….. . Earlier in 2013, galectin-3 testing was included for the first time in the 2013 American College of Cardiology Foundation/American Heart Association Guideline for Management of Heart Failure.
TRADING around book value and cash value it seems to be a good buy as sales are increasing with cost decreasing. The stocks distribution just got wins in China and Japan. This business plan is working and now picking up steam. The latest agreement is Making the stocks products available to millions. The Company is presently focused on diabetic neuropathies, which affect over 50% of people with diabetes. The huge market in the huge country is a big stepping stone to success.
NeuroMetrix . The company's newest product SENSUS came to market in the first quarter of 2013. NeuroMetrix is a medical device company that develops and markets home use and point-of-care devices for the treatment and management of chronic pain, peripheral neuropathies, and associated neurological disorders. The Company is presently focused on diabetic neuropathies, which affect over 50% of people with diabetes. The SENSUS system is used to treat chronic pain linked to diabetic neuropathy. The SENSUS system is the only transcutaneous electrical nerve stimulator that is designed to treat chronic pain associated to diabetes. Diabetic neuropathy is the main cause of this chronic pain with up to 50% of diabetics affected from it. The company estimates that the U.S. market for this type of pain management is over 300 million dollars. The company also has another product on the market which is the NC-stat DPN check. Its main focus going forward though is the SENSUS system. ****** The SENSUS Pain Management System is a convenient and wearable non-invasive electrical nerve stimulator that offers patients a fast-acting, non-narcotic option for relief from chronic pain. The device is lightweight and can be worn during the day while remaining active, or at night while sleeping. It is specifically designed for people with diabetes that suffer from chronic pain. The most common cause of such pain is painful diabetic neuropathy (PDN), which affects up to 5 million people in the U.S. alone.
****** CATALYST-China/Japan/ Simplex Distribution/ Rehabilitation Management Group-clinics / NeuroMetrix announced that it had entered into an agreement with Omron Medical Devices, a subsidiary of Omron Healthcare China, to be the exclusive distributor for NC-stat DPNCheck in China. 2) Earlier this year NeuroMetrix and Omron Healthcare announced a partnership for the exclusive distribution of NC-stat DPNCheck in Japan. NC-stat DPNCheck is a quantitative point-of-care test for early detection of diabetic peripheral neuropathy, which affects over half of people with diabetes. Shares of NeuroMetrix are up 18%, or 54c, to $3.54 in pre-market trading.
3)***** The company also signed an agreement with Simplex Healthcare in September of this year for distribution of the SENSUS system. Simplex Healthcare runs Diabetes Care Club one of the biggest mail order suppliers of diabetes care products. 4)****** The company also signed an agreement in October of this year. The agreement was with OsteoArthritis Centers of America, which is a subsidiary of Rehabilitation Management Group, Inc. This agreement paves the way to having the SENSUS system available in the clinics that operate in affiliation with RMG. These 4 agreements ( Simplex, OsteoArthritus China Japan ) open up a good distribution network that was not there in the first three quarters of this year. 5)GAME PLAN- The company also has a good focus on what it wants to accomplish in the rest of 2013. 6) GUIDING HIGHER- At the time of the company's CC it reported that over 1000 SENSUS systems had been shipped, while the original goal for 2013 was between 1000 and 2000 systems. The company stated that it is now looking to reach the higher end of this range by the end of 2013. FUNDEMENTALS and performance- The sales for the new system are increasing quarter over quarter, while the operating expenses are decreasing quarter over quarter. TIM
people don't ride it down almost a hundred dollars to sell when it is now recommended as the first-line genetic test in pregnancies showing fetal abnormalities on an ultrasound screen................ Just when the products are endorsed and distributed is when to pull the trigger.............. buy buy buy I am expecting a big pop soon.
he would be elected again. HE is AMERICAs gift to the world HISTORY will analyze what he did, step by step, moment by moment to UNITE diversity in the different cultures. To bad there is not war in Benghazi, Syria, Iran , Iraq, Afghanistan, RYAN and McCain wanted and endorse with WAR tough rhetoric. How can the defense spending get replaced? The money OBAMA saved the country by good solid peaceful decisions are enormous. LEGACY in tacked.
World peace is a reality but no legacy. NO WORLD economic crash and no WW3 and nothing done.