Counting my change
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Anyone can question any study. What basis does any of us have on what type of study should have been done? Try to find any bad reviews from people using the product.I can't.It apparently works,bottom line.
I can't believe it! What is the doom and gloom? This is very significant.I am sure they will follow up with an FDA update.
The writing is on the wall!
BioElectronics Technology More Effective Than Extra Strength Tylenol(R) in Reducing Muscle Soreness in Clinical Study
ActiPatch Proved 50 Percent More Effective Than Acetaminophen
* Press Release
* Source: BioElectronics Corporation
* On 4:10 pm EST, Monday November 16, 2009
Companies:
o Bioelectronics Corporation
FREDERICK, MD--(Marketwire - 11/16/09) - BioElectronics Corp. (Pinksheets:BIEL - News) today announced that its disposable drug-free anti-inflammatory devices proved to be significantly more effective than acetaminophen in a clinical study of Delayed Onset Muscle Soreness (DOMS).
The study tested the effectiveness of ActiPatch� Therapy versus acetaminophen in reducing the pain of Delayed Onset Muscle Soreness, a condition associated with increased physical exertion.
"We now have an additional Institutional Review Board (IRB) supervised and National Institutes of Health (NIH) registered clinical study that demonstrates what our customers have been saying for years," said Andrew Whelan, CEO, BioElectronics Corp. "Our products give fast, localized relief from pain and swelling without the danger of drug side effects. We plan to use this additional study to further support our pending 510(K) applications on file at FDA as well as possibly using them in additional applications."
"In the study more than 100 healthy male and female college athletes and trainers were given a vigorous resistance exercise regimen to induce DOMS. They were then randomly divided into three groups; a group that used ActiPatch for two days, a control group that received no treatment, and a third group that was to be treated with acetaminophen," commented Sheena Kong, M.D. the principal investigator. "All participants returned approximately 48 hours after the exercise regime. Upon return those in the ActiPatch and control groups immediately rated their levels of muscle pain and soreness using the Visual Analogue Scale. Participants in the acetaminophen group were given one gram of acetaminophen in the form of Extra Strength Tylenol� and then 90 minutes later rated their levels of muscle pain and soreness using the same scale."
Dr. Kong continued, "The study was conclusive showing that the ActiPatch treated volunteers had significantly less pain than those in either the acetaminophen or control groups. Also of note was the fact that some of the participants assigned to the acetaminophen group were eliminated from the results because they expressed reservations about consuming the drug."
The report notes that there was a highly significant difference between the control group and the group using the ActiPatch, with the control group indicating an average VAS pain level of 3.179 compared to 1.500 for the ActiPatch group where lower numbers indicate lower pain levels. This difference between the two groups was found to be significant at the .001 level. The difference between the acetaminophen group and the ActiPatch group was also highly significant with the acetaminophen group indicating an average pain level of 2.507, i.e., over one point higher than the ActiPatch group. This difference was found to be significant at the .05 level.
ActiPatch technology truncates the human body's natural inflammatory response by breaking the cycle of chronic inflammation. ActiPatch does this by delivering sensation-free pulsed electromagnetic energy and RF waves directly to the affected area and driving out the edematous fluid along with byproducts of the damaged tissue. The effect is well documented and results in a significant overall improvement in the restorative and recovery process following a soft tissue injury. This speedier healing results in a significant reduction in the pain associated with the injury. ActiPatch has been used by thousands of people throughout the world and maintains a 100% safety profile.
The study is Institutional Review Board (IRB) supervised and has been registered with the National Institutes of Health. The principal investigator, Sheena Kong, M.D. holds no financial position in any form in the study's sponsor, BioElectronics Corp., and has not and will not receive financial compensation of any kind for the administration or completion of the study. The acetaminophen used in the study was Extra Strength Tylenol� in 1 gram doses.
A complete copy of the study results and protocol is available on the BioElectronics Corp. web site: http://www.bioelectronicscorp.com.
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch� Therapy, RecoveryRx(TM) Devices, HealFast� Therapy www.healfasttherapy.com and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.
*Tylenol is a registered trademark of McNeil, PPC. Inc.
Contact:
For media enquiries, please contact:
Joe Noel
BioElectronics Corp.
(925) 922-2560
Level 2 update 3x.0006
3x.0007
Level 2 update 8x.0006
2x.0007
3x.0008
1x.0009
4x.001
Level 2 update 9x.0006
3x.0007
Level 2 ask is getting hit like crazy!!
7x.0006 5x.0007
Spectrum Pharmaceuticals Added to NASDAQ Biotechnology Index
* Press Release
* Source: Spectrum Pharmaceuticals, Inc.
* On 12:49 pm EST, Monday November 16, 2009
Companies:
o Spectrum Pharmaceuticals, Inc.
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq: NBI - News). The Company is now a component of the NASDAQ Biotechnology Index®, the Russell 3000®, Russell 2000®, and Russell Global® Indexes.
Related Quotes
Symbol Price Change
SPPI 4.77 0.00
“We are pleased to be added to the NASDAQ Biotechnology Index, as it adds greater visibility for Spectrum Pharmaceuticals,” said Rajesh C. Shrotriya, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “With two marketed drugs, one late stage drug recruiting patients into registrational pivotal trials, a strong team of committed professionals, and a strong financial position, we believe we are well-positioned to deliver outstanding value to our shareholders.”
All securities are classified according to the Industry Classification Benchmark (ICB) as either biotechnology or pharmaceutical. The securities that meet the classification criteria then must meet other Index eligibility criteria including listing on the NASDAQ Global Market or the NASDAQ Global Select Market and meeting minimum requirements for market value, average daily share volume and seasoning as a public company. The Index is ranked on a semi-annual basis in May and November. For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit https://indexes.nasdaqomx.com/.
The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology Index(SM) Fund (IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the NASDAQ Biotechnology Index and the iShares NASDAQ Biotechnology Index Fund trade on various exchanges.
About Spectrum Pharmaceuticals
We are a commercial-stage biotechnology company with a focus in oncology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, that we are well-positioned to deliver outstanding value to our shareholders and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, FUSILEV®, ZEVALIN®, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are registered trademarks of or trademarks owned by Spectrum Pharmaceuticals, Inc. and its subsidiaries.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
He only mentioned the FDA meeting and gave his opinion of how he hoped that it would help move BIEL to a quicker potential approval.However, he did hint that the Tylenol study should be fantastic last week on his last Tweet. But ,with potential big news today he has to be extremely careful,there is too much at stake.
With big news coming after hours,Joe has to keep quiet.He cannot disclose the potential big outcome before the official pr.
Class Action Lawsuit Against Hemispherx Biopharma is Without Merit
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:45 am EST, Monday November 16, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Nov. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") said the recently filed lawsuit is without merit. The lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.
Related Quotes
Symbol Price Change
HEB 1.00 0.00
On July 7, 2008 the Company received the following letter from the Department of Health and Human Services, Food and Drug Administration, which stated:
"Please refer to your April 25, 2008 new drug application (NDA)
submitted under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act for Ampligen (poly I: poly C12U) 2.5 mg/mL Sterile
Solution in 80mL.
We also refer to your submissions dated June 13 and 17, 2008.
We have completed our filing review and have determined that your
application is sufficiently complete to permit a substantive review.
Therefore, in accordance with 21 CFR 314.101(a), this application
is considered filed 60 days after the date we received your
application. The review classification for this application is
standard. Therefore, the user fee goal date is February 25, 2009".
(Emphasis supplied)
Upon receipt of an NDA, the FDA reviewers conduct a filing review to determine whether the application is sufficiently complete to warrant a substantive review. During that filing review, the agency may identify matters involving the organization of the application, needed clarification or additional information which need to be addressed before the agency will decide to formally file the application and begin its substantive review. As reflected in the letter quoted above, FDA informed the Company of the agency's decision to file the Ampligen NDA on July 7, 2008.
Apart from matters affecting the filing decision, the FDA reviewers may, at any time during the review of an NDA, request additional information or clarification of previously submitted information. Such requests made during the course of the NDA review are, by the FDA policy, not considered a determination by the FDA of the status of the NDA or of the prospects for approval of the NDA during the current review cycle (see "Guidance for Industry, Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act" November, 2001). A determination of whether or not any outstanding matters need to be resolved prior to approval is only made, through established internal agency processes, at the end of the review. That determination is made by responsible supervisory reviewers and officials with delegated agency authority, in light of all of the completed reviews, based in part on a risk-benefit analysis which takes into account the clinical importance of the drug and the condition being treated, the strength of the supporting data, and the significance of any potentially outstanding matters. Only at that time is a determination made whether any remaining matters need to be resolved prior to approval or can be properly addressed through available alternative regulatory options or post-approval requirements or commitments.
This is why the cited Guidance explicitly states that an end-of-review action letter may omit matters raised in interim communications (even if they were not addressed by the sponsor) and may include new matters that were never raised in interim communications.
Although, as previously disclosed, FDA reviewers have made inquiries and requested clarification or additional information in connection with their ongoing review of the Ampligen NDA, the FDA reviewers did not seek additional information from the Company either with respect to extension of the first PDUFA date of February 25, 2009, or the second PDUFA date extension on May 25, 2009, and have not indicated in any way that either such extension was related to the need for submission of additional clarification or data. Moreover, based on numerous published reports and statements by Agency officials, it is the Company's understanding that, during the past two years, the Agency has increasingly failed to meet established PDUFA goals due to resource limitations and competing priorities which have often prevented timely completion of NDA reviews (see the FDA presentation, New Drug Review: 2008 Update, available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm117686.pdf ).
As stated in its recent earnings release of November 9, 2009, the FDA has not informed the Company as to any outstanding responses required in order to take action on the pending NDA.
Thus, the class action fraud claim is false. The FDA has in writing stated, "We have completed our filing review and have determined that your application is sufficiently complete to permit a substantive review." Further, the FDA has not sought new information from the Company either with respect to extension of its first PDUFA date of February 25, 2009, or with respect to its second PDUFA date extension on May 25, 2009.
About Hemispherx Biopharma
Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and potentially life-threatening disease with which a new retrovirus was recently associated. Researchers are investigating the possible role of this virus in the symptomatology of the disease using Ampligen(R) as an investigational therapeutic.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
Contact:
Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
This is great news...This is where the financing is coming from.
Trading Outlook for BioElectronics Corporation Issued by StockPreacher.com
* Press Release
* Source: StockPreacher
* On 4:30 pm EST, Thursday November 12, 2009
Companies:
o Bioelectronics Corporation
o Johnson Johnson
o Pfizer Inc.
DALLAS, Nov. 12, 2009 (GLOBE NEWSWIRE) -- StockPreacher.com announces an investment report featuring BioElectronics Corporation (Pink Sheets:BIEL - News). The report includes financial and investment analysis, analyst consensus, and pertinent industry information you need to know to make an educated investment decision.
Related Quotes
Symbol Price Change
BIEL.PK 0.0870 -0.0052
The investment report on BioElectronics Corporation (Pink Sheets:BIEL - News) should be of particular interest to comparable healthcare products providers: Johnson & Johnson (NYSE:JNJ - News), Pfizer (NYSE:PFE - News) and Bayer Aktienges (Pink Sheets:BAYRY - News).
The full report is available at: http://www.stockpreacher.com/n/BIEL
Get our alerts BEFORE the rest of the market. Follow us on Twitter: http://twitter.com/StockPreacher
BioElectronics Corporation is the maker of innovative, patented, drug-free, over-the-counter, anti-inflammation medical devices and patches. The Company's novel approach to pain relief includes a wafer-thin patch containing a microchip and battery that produces pulsed electromagnetic energy, which has proved as an effective and superior method of safe relief of inflammation and pain following injury or invasive medical procedures. The Company markets its present products under the brand names ActiPatch(TM) and RecoveryRX(TM).
Message Board Search for BIEL: http://www.boardcentral.com/boards/BIEL
In the report, the analyst notes:
"The Company's dermal patch pain relief system is an innovative approach to anti-inflammation, which is estimated to address an approximate 400 million number of incidents of acute inflammation conditions each year. The market for anti-inflammation products is anticipated to grow beyond the current $10 billion market worldwide.
"The Company's products have entered Food and Drug Administration (FDA) clinical trials for various and wide number of conditions which have high probabilities of approval. Data released by the Company for the relief of heal and foot pain show a high degree of efficacy, providing widespread optimism and speculation of imminent FDA approval of the Company's Allay(TM) product. According to research firm Alquemie Partners LLC, approval of Allay(TM) could increase the Company's market capitalization to between $300 million and $500 million."
To read the entire report visit: http://www.stockpreacher.com/n/BIEL
StockPreacher.com is a small-cap research and investment commentary provider. StockPreacher.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on StockPreacher, please visit: http://www.stockpreacher.com
StockPreacher.com Disclosure
StockPreacher.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. StockPreacher.com is a Web site wholly-owned by BlueWave Advisors, LLC. Please read our report and visit our Web site, StockPreacher.com, for complete risks and disclosures.
Contact:
StockPreacher.com
Jeff Bishop
(469)-252-3505
press@beaconequity.com
Trading Outlook for BioElectronics Corporation Issued by StockPreacher.com
* Press Release
* Source: StockPreacher
* On 4:30 pm EST, Thursday November 12, 2009
Companies:
o Bioelectronics Corporation
o Johnson Johnson
o Pfizer Inc.
DALLAS, Nov. 12, 2009 (GLOBE NEWSWIRE) -- StockPreacher.com announces an investment report featuring BioElectronics Corporation (Pink Sheets:BIEL - News). The report includes financial and investment analysis, analyst consensus, and pertinent industry information you need to know to make an educated investment decision.
Related Quotes
Symbol Price Change
BIEL.PK 0.0870 -0.0052
Chart for BIOELECTRONICS CORP
{"s" : "biel.pk,jnj,pfe","k" : "c10,l10,p20,t10","o" : "","j" : ""}
The investment report on BioElectronics Corporation (Pink Sheets:BIEL - News) should be of particular interest to comparable healthcare products providers: Johnson & Johnson (NYSE:JNJ - News), Pfizer (NYSE:PFE - News) and Bayer Aktienges (Pink Sheets:BAYRY - News).
The full report is available at: http://www.stockpreacher.com/n/BIEL
Get our alerts BEFORE the rest of the market. Follow us on Twitter: http://twitter.com/StockPreacher
BioElectronics Corporation is the maker of innovative, patented, drug-free, over-the-counter, anti-inflammation medical devices and patches. The Company's novel approach to pain relief includes a wafer-thin patch containing a microchip and battery that produces pulsed electromagnetic energy, which has proved as an effective and superior method of safe relief of inflammation and pain following injury or invasive medical procedures. The Company markets its present products under the brand names ActiPatch(TM) and RecoveryRX(TM).
Message Board Search for BIEL: http://www.boardcentral.com/boards/BIEL
In the report, the analyst notes:
"The Company's dermal patch pain relief system is an innovative approach to anti-inflammation, which is estimated to address an approximate 400 million number of incidents of acute inflammation conditions each year. The market for anti-inflammation products is anticipated to grow beyond the current $10 billion market worldwide.
"The Company's products have entered Food and Drug Administration (FDA) clinical trials for various and wide number of conditions which have high probabilities of approval. Data released by the Company for the relief of heal and foot pain show a high degree of efficacy, providing widespread optimism and speculation of imminent FDA approval of the Company's Allay(TM) product. According to research firm Alquemie Partners LLC, approval of Allay(TM) could increase the Company's market capitalization to between $300 million and $500 million."
To read the entire report visit: http://www.stockpreacher.com/n/BIEL
StockPreacher.com is a small-cap research and investment commentary provider. StockPreacher.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on StockPreacher, please visit: http://www.stockpreacher.com
StockPreacher.com Disclosure
StockPreacher.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. StockPreacher.com is a Web site wholly-owned by BlueWave Advisors, LLC. Please read our report and visit our Web site, StockPreacher.com, for complete risks and disclosures.
Contact:
StockPreacher.com
Jeff Bishop
(469)-252-3505
press@beaconequity.com
Lets not forget The results of the Tylenol study after hours on Monday!
HEB - Case in point http://www.mffais.com/heb
Case in point http://www.mffais.com/heb
If these law suits were a big deal the big boys would be bailing.They aren't and are probably accumulated at this point.Weak hands are running and strong are adding or holding.My opinion.
These law suits are frivolous. They do not even have a lead plaintiff.
Anything is possible,but I have always felt Biel has been on track and their product works. I have read numerous customer reviews,which have all been positive.Also,I think we will find the Tylenol report positive,which will definitely help with pending FDA approval. Just my opinion.
Not an FDA Play but I like this stock....Nature's Peak to be Featured Nationally on The Lifetime TV Network's Weekday Morning Series 'The Balancing Act'
Nature's Peak CEO Paul Wilkinson to appear on an upcoming segment of the Lifetime TV Network show 'The Balancing Act' as part of a series entitled 'Resolution Solutions For Eating Well'
* Press Release
* Source: Everock
* On 5:00 pm EST, Wednesday November 11, 2009
Companies:
o Everock, Inc.
SANTA CRUZ, Calif., Nov. 11 /PRNewswire-FirstCall/ -- Everock, Inc. (Pink Sheets: EVRN - News) announced today that they will be featured in an upcoming segment of the hit show "The Balancing Act" which airs nationally each weekday morning at 7:30AM on The Lifetime TV Network.
Related Quotes
Symbol Price Change
EVRN.PK 0.0150 0.0000
The Balancing Act is part of Lifetime TVs premium TV lineup and is hosted by Beth Troutman and Kristy Villa. The topic of the series - which fits perfectly with Nature's Peak's VeggieDip and VeggieSpread - is "Resolution Solutions For Eating Well."
"This is an incredible opportunity for Nature's Peak to reach our primary target market of women aged 25 and older," said Paul Wilkinson, CEO of Everock/Nature's Peak.
"Plus the theme of the series really allows us to demonstrate that Nature's Peak all natural sandwich spreads and vegetable dips are a delicious and healthy alternative to plain ... and boring ... mayonnaise."
Taping of the show is scheduled for mid-December 2009 and will air several times on Lifetime TV from January through March 2010.
The segment will also be promoted on the web and made available on YouTube, the Nature's Peak website, The Balancing Act website www.thebalancingact.com and other online venues.
"I believe the timing for the airing of this show featuring our products couldn't be better," added Wilkinson. "In fact we plan to coordinate our marketing efforts to really leverage the momentum that being featured on national television offers."
About Everock:
Everock produces a line of all-natural natural gourmet vegetable dips and sandwich spreads marketed under the Nature's Peak brand.
Both VeggieDip and VeggieSpread are 100% all-natural, vegetarian, Kosher and gluten-free, contain no preservatives, artificial ingredients, trans-fats, or sugars. And each product currently comes in six flavors each, including novel delicious flavor combinations.
Nature's Peak products may be found in natural food stores, specialty groceries as well as in regional and national grocery chains. Our products are also served by restaurants, delis and other food service providers across America.
Visit our website at www.NaturesPeak.com to learn more about our products and to discover new and delicious recipe ideas.
Forward Looking Statements:
This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, the Company's ability to develop operations, the Company's ability to consummate and complete an acquisition, the Company's access to future capital, the successful integration of acquired companies, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, sales and other factors that may be identified from time to time in the Company's public announcements.
This press release is provided for information purposes only and is not intended to constitute an offer to sell or a solicitation of an offer to buy securities.
Big buy day for HESG!
http://ih.advfn.com/p.php?pid=trades&symbol=HESG&java_vm=sun&java_vm_ver=1.5.0_10
Health Sciences Group Pursuing Medical Marijuana
INDIAN HARBOUR BEACH, Fla., Nov. 11, 2009 (GLOBE NEWSWIRE) -- Health Sciences Group, Inc. (Pink Sheets:HESG) would like to announce that in addition to finalizing a consulting agreement with Medical Marijuana, Inc. in its pursuit to enter the Medical Marijuana business it has also contacted several law firms in California and Colorado for purposes of licensing requirements for dispensaries.
Thomas Gaffney, Health Sciences CEO, states, "That in addition to entering into a consulting agreement with Medical Marijuana, Inc. (Pink Sheets:MJNA) we have contacted several law firms in Colorado and California pertaining to medical marijuana laws -- basically the requirements of licensing. We have all intentions of entering the world of medical marijuana in the near future. We have also been in contact with some operating dispensaries about possible acquisitions."
We would appreciate shareholder opinion and we can be reached at igohealthy@yahoo.org
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other healthcare professionals through its website www.igohealthy.org and health focused publications. The Health Sciences network consists of its public website www.igohealthy.org and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Medical Marijuana, Inc. to be materially different from the statements made herein.
CONTACT: Health Sciences Group, Inc.
Thomas Gaffney, President and CEO
(321) 604-1451
Speculators Betting on BioElectronics' Upcoming Study Results
* Press Release
* Source: BioMedReports.Com
* On 11:46 am EST, Wednesday November 11, 2009
Companies:
Bioelectronics Corporation
LOS ANGELES, CA--(Marketwire - 11/11/09) - BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, reports that investors are betting that BioElectronics' (Pinksheets:BIEL - News) upcoming medical study results will be significant.
The fact that a U.S. Food and Drug Administration advisory panel and federal regulators have taken aim at over-the-counter (OTC) acetaminophen products is not just the stuff of recent headlines. In fact, since as far back as 1977, FDA advisers have recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days "because severe liver damage may occur." Back then, the FDA never followed that advice although they pledged to quickly consider its advisers' recommendations.
The pendulum has finally swung and now the agency is going out of its way to educate the public after official studies found that many people consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks.
That push and the results of a soon to be released study by BioElectronics Corp. (Pinksheets:BIEL - News) set the table for an intriguing penny play in the coming days. With investors riding the wave of excitement about BIEL's technology and pending FDA decisions, the upcoming news flash will likely make shares of the micro-cap company run up again.
Company officials won't yet officially disclose what the study results will reveal, but there are strong hints in what was released as part of the pilot section of the study last month. That Institutional Review Board (IRB) supervised study is directed at comparing the effects of the company's ActiPatch� Therapy to acetaminophen in the form of Extra Strength Tylenol� for the treatment of delayed onset muscle soreness (DOMS).
The complete report is available now at BioMedReports.Com:
http://biomedreports.com/articles/most-popular/17424-banking-on-biels-upcoming-study-results-against-tylenol.html
Biotech investors interested in accessing the news portal's complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar/fda-calendar.html
About BioMedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. BioMedReports is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies.
For more biomedical sector and investment news go to http://BioMedReports.com
Contact:
Media Contact:
M. Davila
Assistant Editor
BioMedReports.Com
e-mail: Email Contact
Tel: +1 323 472 4480
Fax: +1 888 210 3556
Biel - Why this study is so important - Joe Noel
Everyone:
This study is important for three reasons:
1) It adds further support to out current 510(K) applications. We will present the data to FDA during our meeting with the department director on Friday. We have now completed four studies showing efficacy and have a separate scientific study on the technology. We have sold thousands of units worldwide and have NEVER had a safety issue.
2) The Study has a dual focus - efficacy of ActiPatch and comparison to Tylenol. As most of you know, FDA is adding to its public information campaign to inform the public about the potential dangers of Tylenol. We at the heart of this debate.
3) This new study could easily be used as the basis for an additional 510(K) filing specific to delayed onset muscle soreness (DOMS. We have not yet decided, but it is an exciting option.
4) This study will also enhance our marketability internationally. We are preparing to launch Japan and China, both of which are very exciting markets. Stay tuned.
Joe Noel
Banking On BIEL's Upcoming Study Results
Written by M.E.Garza
Tuesday, 10 November 2009 00:00
The fact that a U.S. Food and Drug Administration advisory panel and federal regulators have taken aim at over-the-counter (OTC) acetaminophen products is not just the stuff of recent headlines. We found newspaper articles dating back over twenty years in which scientists urged stronger warning labels on every bottle of acetaminophen, based on evidence that countless Americans unwittingly took toxic doses that harmed their livers.
FDA Poster
The FDA has now launched new public safety campaigns and bulletins about the dangers of taking too much acetaminophen
In fact, in 1977, the FDA's advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days "because severe liver damage may occur." Back then, the FDA never followed that advice although they pledged to quickly consider its advisers' recommendations.
The slow pendulum has swung and now the agency is going out of its way to educate the public after official studies found that many people consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, more recent reports have said.
Although best known by the Tylenol brand, acetaminophen is in hundreds of branded and generic products, from headache relievers to cold-and-cough remedies. While mostly sold without a prescription, it's also part of the chemical mix in prescription painkillers like Percocet and Vicodin.
So while an estimated 100+ million people a year take acetaminophen, and manufacturers insist that serious liver damage is very rare, government regulators have finally stepped up their fight to educate and warn consumers that swallowing a few extra pills in hopes of faster pain relief and falsely thinking that over-the-counter medications are safe enough to push the dose are a mistake and could result in unknowingly ingesting potentially toxic amounts.
BioElectronics Corporation
0.07 +0.01 (+20.83%)
Intraday | 3 Month | 6 Month | 1 Year
Quotes delayed at least 20 mins.
That push and the results of a soon to be released study by Bioelectronics Corp. (OTC:BIEL) set the table for an intriguing penny play in the coming days. The company made this year's 10 Stock BioMed Momentum Index, with investors riding the wave of excitement about the technology and pending FDA decisions, but the upcoming news flash will likely make shares of the micro-cap company run up once again. How far the stock will rally remains to be seen, but even without official news, speculators moved the stock up over 20% on Tuesday (still well below established resistance levels)- and results from the medical study aren't even scheduled to be released for at least a few more days.
Company officials won't yet officially disclose what the study results will reveal, but there are strong hints in what was released as part of the pilot section of the study last month. That Institutional Review Board (IRB) supervised study is directed at comparing the effects of the company's ActiPatch® Therapy to acetaminophen in the form of Extra Strength Tylenol® for the treatment of delayed onset muscle soreness (DOMS).
Participants in the pilot section of the study were randomly assigned to one of three groups, 1) a control group, 2) a group that used ActiPatch, and 3) a group that was treated with over-the-counter strength acetaminophen. Each of the group's participants then evaluated their levels of muscle soreness and discomfort 48 hours after vigorous resistance training designed to induce delayed onset muscle soreness.
The results from the October section of this study seemed to be highly statistically significant with the ActiPatch® group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group according to principal investigator Sheena Kong, M.D.
BioElectronics's wearable ActiPatch® delivers pulsed electromagnetic therapy to reduce pain and swelling and accellerate healing. The technology was recognized by the Wall Street Journal as one of the year's best innovations and the company was quick to jump on the "anti-acetaminophen" bandwagon with this study since the product appears to address the same medical needs as Tylenol® while maintaining its status as a 100% drug free product which not only relieves pain, but is also proven to repair damaged cells and minimize swelling and bruising- all without drug interactions and side effects.
"For many years physicians, medical researchers and sports trainers attributed this type of muscle soreness to the build up of lactate in muscle tissues after exercise," said investigator Kong. "A significant body of research now shows delayed onset muscle soreness is mainly attributable to damage to the muscle cell membrane, which sets off an inflammatory response leading to the formation of metabolic waste products that act as a chemical stimulus to the nerve endings that directly cause the pain that is experienced after muscle over exertion. While additional research needs to be conducted on the actual mechanism, it appears ActiPatch® works to reduce this inflammatory response resulting in a reduction in the formation of metabolic waste products and therefore, what appears, based on these preliminary results, to be a significant reduction in levels of muscle pain and soreness."
If the results come back as positive as expected, I'd look for BioElectronics to push more headlines and use the data to promote the brand as an alternative to acetaminophen more agressively than ever.
Disclosure: Long BIEL
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
Potential Hot Stock MCLN MedClean Technologies
MedClean Technologies, Inc. is a provider of innovative technology and services for the onsite treatment and disposal of regulated medical waste. MedClean’s flagship MedClean® Series systems are fully integrated, turnkey technology solutions that enable hospitals and other healthcare providers to safely, efficiently, and cost-effectively convert bio-hazardous regulated medical waste into sterile, unrecognizable material suitable for disposal as municipal solid waste. MedClean was founded in 1997 with corporate headquarters, research and development and distribution facilities located in Bethel, Connecticut.
MCLN sets the standard for efficacy testing and validation through an ongoing commitment that has resulted in the most extensive body of work in the industry. The MedClean System meets and exceeds the most demanding standards throughout all 50 states. Our work in this area has yielded a protocol that includes significant proprietary intellectual property and is the subject of a United States patent. All MedClean efficacy testing and protocol development is conducted using actual RMW from healthcare institutions to mirror real world operations.
MedClean Technologies is committed to ongoing research and development in this area and to close collaboration with industry experts to provide continuous enhancement of its Best Practices.
Now more than ever their technology is in high demand.
$$$$$$$$And they are fully transparent and profitable.
As always,do your DD!!
Hemispherx Biopharma, Inc. 3rd Quarter 2009 Financial Results
Cash/Cash Equivalents Increase Almost 10 Fold and Net Loss for Quarter Reduced 29%
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 3:00 pm EST, Monday November 9, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Nov. 9, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended September 30, 2009. The net loss (including non-cash expenses) for the fiscal quarter was approximately $2,435,000 or $0.02 per share compared to a loss of approximately $3,415,000 or $0.05 per share for the same period in 2008. The decrease in loss was primarily due to 1) lower R&D expenses related to the preparation of the Ampligen(R) NDA and, 2) the effect of reducing G&A expenses pursuant to the cash conservation and cost reduction program implemented by Management in early 2009. The net loss for the nine months ended September 30, 2009 including non-cash expenses was $9,392,000 or $0.09 per share compared to a loss of $9,382,000 or $0.13 per share in 2008.
Related Quotes
Symbol Price Change
HEB 1.23 +0.01
Chart for HEMISPHERX BIOPHARMA
{"s" : "heb","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Cash and cash equivalents were $61,042,000 as of September 30, 2009 reflecting an increase of $54,923,000 since year end 2008. This increase primarily reflects the net proceeds of two equity placements in May, 2009 as well as proceeds derived from an equity financing agreement.
The Company presented new data at the Chronic Fatigue Syndrome (CFS) Advisory Committee to the Department of Health and Human Services (HHS) on October 29, 2009, regarding patient referral patterns in CFS and outlined new collaborative clinical research for the "Longitudinal Study of Gene Expression in CFS". On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).
The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
The Company has initiated a $4.4 million capital investment program to upgrade its production facility located in New Brunswick, New Jersey. This facility produces Alferon N Injection(R), a commercial product for the treatment of refractory human papillomavirus (HPV), and the raw materials used to produce its experimental therapeutic drug, Ampligen(R). Both pharmaceutical platforms lend themselves to multiple drug delivery approaches including nasal and sublingual routes.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R), Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 patents comprising its core intellectual property estate and commercially approved product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders under Treatment Investigational New Drugs (IND) conditions. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
Contact:
Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
Redefining Breast Cancer Detection (OTC:LLBO)
Submitted By StocksHaven
Lifeline Biotechnologies Inc.
(Public, PINK:LLBO)
With the recent gains in Hard to Treat Diseases Inc. (PINK:HTDS) and BioElectronics Corp. (OTC:BIEL), investors were left hungry for more undervalued, high potential biotech companies — Then came LifeLine Biotechnologies Inc (OTC:LLBO). As technology continues to redefine the modern era of medical advancements, certain companies will stand apart from the rest, as is the case with Lifeline Biotechnologies Inc. This company is an innovative medical technology company committed to the improvement of the quality of life through exceptional health care systems, focusing on prevention, early diagnosis, and quick recovery. Recently, the company has made headlines with their innovative Breast Cancer detection system, the First Warning System ™, a dynamic test which collects information over time with an uncanny efficacy. The next several months will prove to be critical for LifeLine Biotechnologies, as they await the FDA’s decision on a classification for their device, which will in turn paint a more clear picture of the company’s future direction.
About LifeLine Biotechnologies Inc:
Lifeline Biotechnologies, Inc. operates as a medical technology company in the United States. Its technologies focus on prevention, early detection, diagnosis, and quick recovery of various disease conditions. The company is developing a non-imaging technology, known as the First Warning System, which measures tissue activity for the early detection of breast cancer in women. Lifeline Biotechnologies was incorporated in 1981 and is based in Reno, Nevada.
Products
First Warning™
Lifeline BiotechnologiesTM is developing a non-imaging technology called First Warning™ that measures tissue activity. The technological concept behind First Warning™ is that new blood vessels supplying a breast cancer do not respond to normal physiological control mechanisms (vasoconstriction and vasodilatation). Therefore, cancers produce time-related circadian (24 hour) pattern change not seen in normal tissue. It is proposed these changes in the circadian rhythm “chaos” is taken as a signal of high risk for breast cancer even in the absence of mammographic evidence.
Essential to understanding how Lifeline’s First Warning™ system can effectively detect tiny tumors at such an early stage is an understanding of how a tumor develops. Click here to read the company’s website.
First Warning™ is a dynamic test (like a motion picture) collecting information over time, unlike traditional imaging systems, which are static providing a snapshot of information at the time of the test. The monitor records information every 5 minutes for the duration of the test, collecting over 9,000 data points. The data is then subjected to non-linear algorithmic computer analysis designed to identify abnormalities or disruptions in the normal breast physiology.
The First Warning™ system can be applied in the primary care physician’s office. This non-invasive, painless and easy to wear system consists of sixteen tiny sensors (5 mm), eight on each breast. The sensors connect to a small monitor (about the size of a pager) that is attached to the bra. The system (designed to be worn under normal clothing) enables the woman to maintain normal daily life. First Warning™ will provide additional valuable information to supplement palpation and mammographic findings. Helping the physician answer the question “What am I feeling?” or “What am I seeing?”
Potential Target Market
With more than 200,000 diagnoses and 40,000 deaths each year, breast cancer is the most frequently diagnosed malignancy in the U.S. and is the second-leading cause of cancer mortality in women. More than 2 million women in the U.S. have been treated for breast cancer; as with other cancers, early detection and treatment of breast cancer dramatically improves survival rates.
Sales of breast-specific screening and diagnostic products (e.g., biological tumor markers, breast biopsy products, computer-aided detection systems, conventional and digital mammography systems, emerging breast cancer detection products, pharmacogenetic and prognostic testing products, and susceptibility testing products) totals approximately $690 million. In addition, sales of non-breast-specific diagnostic technologies (e.g., nuclear imaging products, magnetic resonance imaging products, and ultrasound products) totals approximately $4 billion. Sales of these products are expected to increase significantly within the next few years as incident rates continue to increase exponentially.
Competition (Mammograms)
For breast cancer, of course, the mammogram is generally regarded as the best means of early detection. Mammograms, however, usually require a referral and a separate visit to a radiology center – and can potentially miss over 30 percent of breast cancers. And for cancers of the reproductive organs, the Pap smear is only indicated for the early detection of cervical cancer. Meanwhile, more than 25,000 cases of ovarian cancer are diagnosed a year, usually at the stage where they are symptomatic. As a result, the overall mortality rate for ovarian cancer is currently between 53 and 75 percent.
Many health authorities favor attempting to distinguish women who are likely to develop breast cancer, based on varying elements of risk, from those who are not. The flaw in any risk-based approach to screening for breast cancer becomes apparent if one considers that as many as 60%-70% of all breast cancer patients have no obvious risk factor. Simply stated, the available screening programs, despite being directed toward finding early stage disease, do not adequately warn women or their physicians that breast cancer is present in its earliest or preclinically detectable stages.
Over 30 million mammograms will be done this year; of this group, 1.1 million women will be subjected to breast biopsies. From these biopsies, 185,000 new breast cancer cases will be found. Unfortunately, another 915,000 or 83% of women will be told their biopsies were benign. The accurate detection of pre-cancerous lesions is the key to making a major step forward in the eradication of this disease.
Clinical Trials & FDA News
On January 7, 2009, LifeLine Biotech announced that management will focus efforts to bring its First Warning System™ to market, since then the company has had a very busy year. Jim Holmes, CEO of Lifeline Biotechnologies said “The First Warning System™ with test results from over 700 women, the computer software has achieved technology levels in its capabilities of identifying and classifying abnormalities of the breast with sensitivities of 95% to 100% and specificities of 87% to 90%. Last year we filed for a patent covering these technology advances.”
Holmes continued to say that “With these levels of capabilities the First Warning System™ could potentially be commercialized later this year. There is some work ahead of us in order to be in position for market introduction, but it is possible we could, and hopefully, will introduce the system later this year.”
Lifeline Biotechnologies, Inc. is focused on market introduction, either directly or through a strategic alliance with a industry partner, the First Warning System™, which is designed to assist in the early detection of breast cancer. Of the approximately $138 billion spent on cancer each year, Lifeline could potentially save the health-care industry billions of dollars annually, assuming the following are successfully completed: Additional clinical trials (if required) and filing and receiving a 510(k) from the FDA, upgrading of hardware and market acceptance of the product.
Four Patents on The First Warning™
These filings relate to four essential elements in its system for analyzing temperature readings of breast tissue to identify cancerous tissue. The patents address the First Warning System’s ™ method for the placement of temperature sensors to obtain reliable temperature readings, its method for analyzing the temperature readings, and its placeholder for assuring proper sensor placement. In addition, a fourth application was filed under the Patent Cooperation Treaty (PCT) to extend Lifeline Biotechnologies’ protection, internationally, on all of the existing patent filings and existing intellectual property including these new filings. See more information here.
To view more patent information, as well as the filing date, please visit the government’s website here.
Technical Chart Analysis (click imagine to enlarge)
These past two months have seen an explosion in volume for LLBO as it appears to be gaining momentum for another healthy increase in share price. The year to date price action has established a well defined price channel shown in Blue on the chart. The top of this price channel is currently at .02 cents and we’ve seen the price visit this level twice already. The first time was back in February and the run took 12 days for a gain just over 340%. The second time was in July and the run only took half the time (6 days) for a gain of just under 3000%! Currently, there appears to be a resistance level around .005 cents and this corresponds closely to the ¼ trend-line of the Blue channel. Today, the price took a look above this trend-line up to .0059 cents and closed right at the .005 cent resistance level with a tall Green candle on almost 290,000,000 shares of volume. The last time the price closed above this .005 cent level with similar volume was that monster run back in July to the very top of the price channel. In fact, the price took a look above the top line of the channel up to .0245 cents and indicates there could be much more height to the channel. It’s good to keep in the back of your mind that the top of the price channel has already been tested twice and, as we have seen numerous times, the third time is the charm to finally break out.
Overall Sentiment
Investors in LifeLine Biotechnologies have many reasons to continue believing in the company both in the short term, and the long term. Firstly, they are updating the information on Pink Sheets, which is always a good sign indicating that management expects a positive flow of revenues and income ahead. Add to that the four patents, and an FDA filing alongside a stock which is at one of its lowest price points year-to-date and you have yourself one of the most undervalued micro-cap biotech plays around. A potential target market estimated in the billions, with the product having being tested on over 700 women with the capabilities of identifying and classifying abnormalities of the breast with sensitivities of 95% to 100% and specificities of 87% to 90% and you have yourself one of the most undervalued micro-cap companies in the biotech industry.
———–
Biel Update From Joe Noel
Everyone:
Here is the latest on BIEL. Sorry not to be able to respond to all your messages - Have about 100 between Tuesday and Today.
FDA - We have a meeting with FDA ONE WEEK FROM TODAY!!!!!! We believe the hold up on clearance is a classification issue. We are a Class III but we have applied for reclassification. We think FDA is holding clearance until we are reclassified to Classs II. The big news is FDA has invited us to a meeting on Friday of next week to discuss the isuse. We are hoping this will resolve things. Very exciting!!!
Tylenol Study - IT IS DONE. SHOULD HAVE RESULTS NEXT WEEK!
Direction of the Company - Monday was a huge day for BIEL. For the past year I have continued to tell you that the priorities of BIEL are 1) clinical trials, 2) FDA clearances, and 3) building the brands. On Monday we finalized our marketing plan - BIEL's priorities have now changed. It moves BIEL to a new chapter in its corporate life. It is now one of revenue generation. Over the next few months you will here a lot about this new chapter of rev generation. Also will hear a lot about our entry into Japan and the domestic and international TV ads we have designed - very classy and high quality.
None of us at BIEL have lost any confidence. We feel FDA clearance is not a matter of if - only when - this meeting with FDA next Friday should be very interesting and we hope the event that breaks the log jam. Joe Noel
One more thing,once financing is all in,production will start and take up to 60 days to all distributors and 30 more to overall retail market. If everything continues to be good,Walmart and the big boys will be summer 2010.Walmart said they want the product now ,but EVRN does not want to take on more that they can handle right now.If they did and could not deliver,it would be product suicide.These boys know what they are doing. The sign of a solid growing company.
Thanks Tim!!!!
NRIFF - FDA Approves Pennsaid® Topical Solution
Covidien, Nuvo Research Inc. Collaboration Achieves Significant Milestone in Support of Covidien’s Expansion in Branded Pain Management Market
* Press Release
* Source: Covidien
* On 7:00 am EST, Thursday November 5, 2009
Companies:
o Covidien Plc
ST. LOUIS & MISSISSAUGA, Ontario--(BUSINESS WIRE)--Covidien (NYSE:COV - News), a leading global provider of healthcare products, and Nuvo Research Inc. (TSX:NRI - News), a Canadian drug development company, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid® Topical Solution (diclofenac sodium topical solution) 1.5% w/w.
Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee.
Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.
“FDA approval of Pennsaid is the most significant milestone in Nuvo’s history,” said Dan Chicoine, Chairman of Nuvo Research. “We are thrilled that we have been able to successfully navigate a very challenging regulatory pathway for this product and look forward to the upcoming launch of Pennsaid in the U.S. by Covidien. This will support the development of our product pipeline as we progress toward becoming the global leader in the research and development of drug products delivered to or through the skin.”
“Building on more than a century of pain treatment experience, Covidien is focused on expanding the limits of pain therapy by combining proven drugs with innovative delivery systems,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “We are pleased to be collaborating with Nuvo Research on this opportunity to expand our branded pharmaceutical portfolio by selling and marketing Pennsaid throughout the United States.”
In June, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and its follow-on topical diclofenac formulation, Pennsaid® Plus Gel, which is currently under development. Under the agreement, Covidien is responsible for all U.S. commercialization activities, including marketing, selling and medical education and is responsible for the clinical development of Pennsaid Plus. Nuvo owns and maintains the intellectual property rights to the products and also will be responsible for manufacturing.
The launch of Pennsaid Topical Solution, which Covidien anticipates in the first half of calendar 2010, will include a NSAID medication guide for prescribers, pharmacists and patients.
About Covidien
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies and on the development of its immune modulation drug candidate, WF10. Nuvo’s lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID). Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany and a research and development Center in San Diego, California. For more information, please visit www.nuvoresearch.com.
Forward-Looking Statements
Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.