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    Tagged fda

    NASDAQ Getting Punished BioElectronics Corporation (BIEL.PK) up 32% On FDA News

    Posted on August 8, 2011 by

    BioElectronics Corporation (BIEL.PK)

    FREDERICK, MD–08/08/11- BioElectronics Corp. (Pinksheets: BIEL.PK – News), the maker of inexpensive, disposable drug-free topical pain devices, is pleased to announce it has filed a response to the FDA concerns on the mechanism of action for the Company’s Allay™, Menstrual Pain Therapy product. This response is predicated on additional physiological research, independent studies, and confirming bench testing to verify the working basis for the clinical results produced by its therapy. The research has established a unique patentable mechanism of operation and justification for moving the device into the FDA’s lower safety Class II category. Additionally, the defined safety profile of the mechanism of operation demonstrates less risk than the FDA’s approved Class I, over-the-counter heat products.

    500_1199404230_395364_3734"We are very pleased to inform the industry and our investors that we have responded to the FDA’s concerns with a defined and viable mechanism of action. The energy emitted by the Allay device was previously thought to act as only an undefined non-thermal mechanism. We have provided the FDA with extensive performance data that establishes the physics and clinical efficacy of our exceptional therapy. The Allay device offers a simple way of providing dual electrical and continuous low-level, safe, deep heat therapy. This product brings a very significant level of monthly comfort, mobility, and pain relief to millions of women around the world."

    Recognized by the Wall Street Journal as one of the top medical innovations of 2009, Allay is recommended by physicians as a safe and effective treatment. In fact, clinical study results show that 77.1% of women using Allay reported complete elimination or significant reduction in their typical menstrual symptoms. More importantly, the Company is very pleased with Allay repurchase results.

    Mr. Whelan continued, "Last week we announced that we are expecting a near-term decision from FDA relative to our RecoveryRx™ surgical recovery product. Our FDA reclassification filing for our Allay Menstrual Pain Therapy product is a separate issue and thus we are now waiting for a second separate decision. We have approached both responses to FDA based on hard scientific facts and we believe we have supplied the examiners with a strong body of evidence in answering their questions. We are eagerly awaiting near term FDA’s responses relative to both of these profound healing and pain relieving therapeutic agents."

    About BioElectronics Corporation

    BioElectronics Corporation is an award winning medical device developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal complaints, the Allay™ Menstrual Cycle Pain Therapy, and RecoveryRx™ for surgical procedures and wound care. The unique therapy delivery system, using patented technology, provides a cost-effective home care to reduce soft tissue pain and swelling. For more information, please seewww.bielcorp.com.

    Chronic Inflammation Is Closely Related To Many Diseases And Conditions Associated With Aging

    Posted on November 23, 2010 by

    (11/17/10) – Spencer Pharmaceutical Inc. (SPPH) announced that it has released some of its scientific results.

    The company states that chronic inflammation is closely related to many diseases and conditions associated with aging as well as arthritis, gastric reflux disease, colitis, some forms of cancer, Alzheimer’s disease, immune dysfunction, etc. There is a great need for effective treatments that will be simple with no adverse side effects.

    Generally, Ibuprofen (OTC) is rapidly absorbed following oral administration, and possesses a plasma half-life of approximately 2 hours with 80 % of the administered dose excreted in urine. Consequently, the immediate-release dosage of ibuprofen is 200 mg every 4-6 h, with a maximum dosage of 1200 mg over 24 hours. In simple language, there is a big demand on the market for slow release Ibuprofen.

    “Spencer Pharmaceutical has developed such a slow release and unique formulation for NSAIDs controlled release, particularly Ibuprofen, under direct compression on monolithic tablet format, which are able to deliver immediately an effective dosage of the molecule and the remained dosage over a delayed period of 8-10 hours,” stated Dr. Max Arella, CEO of Spencer Pharmaceutical Inc. Furthermore “The matrix (excipient) is based on natural molecules and stabilized under ionic forms. All ingredients are 100 % GRAS (generally approved as safe) and already approved as acceptable substances by FDA,” pointed out Dr. Arella.

    The company also points out, in vitro dissolution showed the novel monolithic tablet (600 mg) of ibuprofen is rapidly delivered in simulated gastric fluid (SGF, pH 2.0) with approximately 25 % released during the first hour and the remaining dosage of ibuprofen is sustained for released over the remaining 10 hours. The easy and non-expensive matrix developed by Spencer Pharmaceutical is currently being submitted for patent protection.

    “We are excited by these new results and we are confident that many applications will be found for this new matrix developed by our scientists,” commented Dr. Max Arella, CEO of Spencer Pharmaceutical. Read the rest of this entry »

    #1 Reason People Fail Trading Penny Stocks

    Posted on July 14, 2010 by

    How do you know when a penny stock is undervalued or overvalued? If you are new to penny stock trading this is very important. The difference in your timing of getting into a penny stock can be either huge gains or huge losses. Thestockwizards.net prefers the huge gains.

    What we are going to do today is look at a few examples so you understand when you should be getting in a stock or getting out of a stock. We are talking about penny stocks not big board stocks in these examples just to make that clear.

    Let’s use some examples of penny stocks that made huge gains in 2009. This was a year of biotech, medical equipment and pharmaceuticals in the penny stock arena. So the stocks we will use are from these sectors.

    The first stock that we will talk about is the one that could’ve made us all rich and well-off, if we just had 20-20 hindsight.

    VRMLQ: This is a stock that was a life changer for a few traders in the penny stock world. The stock went from .05 to as high as $23, that’s right $23. Now you are wondering what made the stock go so high Read the rest of this entry »

    TheStockWizards.net (TSW) Presents its Top 10 Penny Stocks for the Week of July 5th 2010

    Posted on July 3, 2010 by

    The StockWizards.net top 10 stocks for the week include QASP, ARSC, CDIV, ATNP, SBRH, TDGI, KATX, SSWC, BUGS, and MOPN.

    Boca Raton, FL- TheStockWizards.net reviews stocks that have impact news and favorable technical charting indicators on the OTCBB and Pink sheet exchanges. TSW is quickly becoming the fastest growing network destination for Small-Cap, Micro-Cap & Penny Stocks. With  over 30 years combined experience; our team of research analyst pride themselves on bringing our members the hottest stock alerts.
    At The Stock Wizards, we analyze daily market activity and provide our members with our technical outlook, winning stock picks, a weekly top ten list, and daily trading tips from the Traders Corner section of our website.  We follow certain patterns and bring you break out alerts, volume spikes, breaking news, upward trends, mergers and more.  We do all the research for you and send it straight to your inbox.

    1. QASP: ($ .0068) A very low risk trade at these levels in our opinion. QASP is working off of a technical double bottom on the daily chart. Needs to stay above (.0055) on a weekly basis.

    2. ARSC: ($ .0003) In a bear market, these are the kind of stocks traders and investors are looking for.  ARSC  is right at its 200-day moving average. This will get the attention of technical traders. Looks like a low risk trade at this level. Read the rest of this entry »

    Information Is The Most Valuable Commodity When Trading Stocks

    Posted on May 4, 2010 by

    So you want to get into the game of day trading stocks? Whether you’re a rookie or veteran of the stock market, The Stock Wizards encourages traders and investors to look for stocks with forward-looking events. What is a forward-looking event? A forward-looking event is when a company announces publicly through a press release that there will be some kind material event that will affect the company in the future. Another way of looking at it is using the term Catalyst.

    How do we find such companies? We gather as much information about a company as we can before investing our hard earned money. Information is the key word here. Remember Michael Douglas’s famous quote from the movie Wall Street? “The most valuable commodity I know of is information, wouldn’t you agree?” And let’s not forget the high tech society we live in today. Information is right at our fingertips so there are no excuses for not doing the research. A little research goes a long way when searching for companies with forward-looking events. Read the rest of this entry »

    Hot Stocks for March 23rd 2010 PMI CTIC JSDA ARWR

    Posted on March 23, 2010 by

    PMI Group, Inc. (NYSE PMI) JSDA

    WALNUT CREEK, Calif., March 23, 2010 The PMI Group, Inc.’s (NYSE: PMI) principal operating subsidiary, PMI Mortgage Insurance Co. (MIC), today announced that Freddie Mac has approved PMI Mortgage Assurance Co. (“PMAC”) as a direct issuer of mortgage guaranty insurance. PMAC is a subsidiary of MIC. Pursuant to Freddie Mac’s approval, PMAC may write new mortgage insurance business in certain states in the event that MIC is required to cease writing new mortgage insurance business in those states due to its inability to meet applicable regulatory capital requirements. Freddie Mac’s approval, which is subject to certain conditions and restrictions, will remain in effect until December 31, 2011. As previously announced, Fannie Mae has also approved PMAC as a direct issuer of mortgage guaranty insurance.

    Technical Outlook PMI  has made a new 3 month high. The short-term resistance level of 3.41 has been broken. Traders and Investors will focus in on 3.41 as a new support level for this week. if this level is maintained on a weekly close this would be bullish for the stock. Next major resistance will be the psychological 5.00 level. A breakthrough this level would spark a new round of momentum in the stock.

    Cell Therapeutics, Inc. (NASDAQ) CTIC

    GAITHERSBURG, Md., March 22, 2010 Cell Therapeutics, Inc. (“CTI”) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration’s (the “FDA”) Oncologic Drugs Advisory Committee (“ODAC”) panel voted unanimously that clinical trial data was not adequate to support approval of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”). Currently, there are no approved drugs for patients with relapsed or refractory aggressive NHL that have received two or more prior therapies. Pixantrone would be the first drug approved by the FDA for this indication. The FDA is not bound by the recommendations of its advisory committee and the agency is expected to make a decision whether to approve pixantrone for this use by April 23, 2010.

    Technical Outlook: CTIC challenged the psychological .10 support level in yesterday’s trading and it held. Short-term support is .50 Strong resistance will be 1.00 CTIC is currently up 35% on 46 million shares traded in the morning session.  If you do not know what psychological support and resistance is when trading penny stocks please read our latest article on the subject. Click here http://tiny.cc/ivit

    Jones Soda Co. (NASDAQ) JSDA

    LOS ANGELES, CA, Mar 22, 2010 Reed’s, Inc. (NASDAQ: REED), maker of the top-selling sodas in natural food stores nationwide, announced today that Jones Soda, Inc. (NASDAQ: JSDA) has received an unsolicited offer by a third party and has terminated the exclusivity provision of the Letter of Intent (LOI) signed with Reed’s, Inc. on March 9, 2010.

    As stated in the Letter of Intent, Reed’s, Inc. had come to mutual terms with Jones to acquire the company for approximately $9.8 million in cash and stock. On March 19th, 2010, Jones informed Reed’s that it received an unsolicited proposal that it would like to pursue while continuing to have discussions with Reed’s, Inc.

    Technical Outlook:

    JSDA is flirting with a major breakout above the 200 day moving average(.75). Traders and Investors will be focused in on this technical event. JSDA is currently up 36% on 750,000 shares traded in the morning session .

    Arrowhead Research Corp. (NASDAQ: ARWR)

    PASADENA, Calif., Mar 22, 2010 Arrowhead Research Corporation (NASDAQ: ARWR) today announced that the clinical trial being conducted by majority-owned subsidiary, Calando Pharmaceuticals, Inc., has demonstrated systemic delivery of siRNA and the successful “silencing” of a widely recognized cancer gene via RNA interference (RNAi) in humans. This represents a breakthrough for Calando, its proprietary RONDEL(TM) delivery system, and the field of RNAi. It is thought to be the first ever demonstration in humans of targeted siRNA-containing nanoparticle delivery to tumors using systemic administration, delivery of functional siRNAs, and achievement of specific mRNA and protein reductions via RNAi. Thus far in the trial, no significant drug-related toxicities, known as serious adverse events (SAEs), have been observed that may limit use. Data based on Calando’s study were published in the prestigious journal, Nature, on March 21, 2010 in an advance online edition. The article, titled, “Evidence of RNAi in humans from systemically administered siRNA via targeted nanoparticles,” can be viewed at: http://www.nature.com/nature/journal/vaop/ncurrent/full/nature08956.html. Further discussion of the article and the data may also be viewed at: http://www.nature.com/news/2010/100321/full/news.2010.138.html.

    Technical Outlook: ARWR exploded yesterday on nice news. Traders and Investors are focused in on the psychological 1.00 area. The big question will be will the stock close above the psychological 1.00 level for the week. If we get a weekly close above this level you could see a new round of momentum in the stock. ARWR finished up the day  92% on 25 million shares traded.