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OPAXIO(TM) Combined with Alimta(R) Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer
Date : 08/03/2009 @ 1:30AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1249317508&article=38871733&symbol=N^CTIC
Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine)
Date : 08/03/2009 @ 8:30AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1249315877&article=38878655&symbol=N^KERX
EXACT Sciences: FDA-Cleared Test Key to Future Earnings
Written by Mike Havrilla
Saturday, 01 August 2009 15:04
http://biomedreports.com/articles/most-popular/3973-exact-sciences-fda-cleared-test-key-to-future-earnings.html
The stock research section of BioMedReports.com has been updated on 8/1/09 for my new report on EXACT Sciences (NASDAQ:EXAS), which provides a more comprehensive and global earnings model for the Company's next-generation stool DNA (sDNA) screening test (V3) for colorectal cancer (CRC) since my previous article in mid-July.
The following is a summary of the highlights, projections, and expected milestones from my 14-page PDF report for EXAS:
1.) Key financial metrics include about 35 million shares outstanding, $28.8 million cash/equivalents, and no debt
2.) Adequate liquidity through at least late 2010 with modest dilution up to 40 million shares expected through 2012
3.) Planned FDA submission in 2011 of V3 sDNA CRC screening test for marketing clearance
4.) Collaborations with Mayo Clinic and Genzyme (NASDAQ:GENZ)
5.) EXAS has a proven executive leadership team from Third Wave with experience in molecular diagnostics. Third Wave was sold to Hologic (NASDAQ:HOLX) in 2008 for $582 million, and the management team led the successful clinical development and FDA clearance of screening tests for cervical cancer while at Third Wave.
6.) Pending clinical trial with 8,000-10,000 subjects enrolled at 30-40 clinical sites with a goal of obtaining broad claims for a non-invasive sDNA-based CRC screening test, including the detection of pre-cancers and adenomas
7.) Expected market launch of a FDA-cleared, V3 test during 2011 with first full year of sales in 2012
8.) The V3 sDNA screening technology outperforms blood-based tests, especially for earlier stage disease detection, which is critical for improved treatment and survival outcomes. In August 2008, research was published in which a total of 25 sDNA samples from CRC patients were analyzed and a next generation sDNA technology (V3) correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA.
9.) A five-year interval for sDNA CRC screening equates to about 16 million people in U.S. eligible for annual screening; while a three-year interval ups the number to 27 million. Significant upside is possible based on wider adoption of preventative medicine as part of U.S. healthcare reform, especially in the area of screening tests for the early detection of cancer as it much cheaper and more beneficial to patients to prevent or begin treatment of CRC in early stages.
10.) Key earnings model assumptions include a recommended three-year screening interval for the FDA-cleared V3 technology as a mass-screening test for the average-risk population with the ability to detect pre-cancers and adenomas. Three key regions reflected in earnings model include North America, Europe, and Asia-Pacific with estimated populations in each of about 100 million people over the age of 50 eligible for the V3 sDNA screening test for CRC.
11.) The models include estimated market penetration rates of 10% in 2012 and 15% in 2013 on a global basis. The U.S. marketing plan is likely to involve direct licensing of FDA V3 test kit to major labs throughout the country. The ex-U.S. marketing plan is expected to involve a combination of licensing deals with regional diagnostic companies/labs and/or a multi-national firm such as Abbott Labs (NYSE:ABT) or Roche (RHHBY.PK) with a significant diagnostics business
12.) The market opportunity in the U.S. alone equates to potential earnings power exceeding $4/share for EXAS in 2012, assuming a 10% market penetration rate for 100 million people over age 50 with $150 reimbursement rate and a recommended three-year testing interval. Market opportunities in Europe and Asia-Pacific regions equate to over $4/share in additional earnings power in 2012 with lower reimbursement and royalty rates assumed for these regions, but EXAS would not bear any of the expenses for marketing or sales as ex-U.S. opportunity represents a pure-play on licensing royalties.
13.) The major risk factor underlying the models presented in the report are pending results in the clinical trial for FDA clearance. The Company's goal is to obtain a broad, FDA-cleared test with 80-90% sensitivity for the detection of CRC and 65-70% for pre-cancers in the average risk population for a three-year testing interval recommendation.
EXAS will provide an updated corporate presentation along with its 2Q09 operating results on 8/12/09 with a conference call scheduled for 10 am (ET) on that day.
FDA Calendar Extreme Trades: 30 Stocks Under $5
Written by Mike Havrilla
Saturday, 01 August 2009 10:34
http://biomedreports.com/articles/most-popular/3969-fda-calendar-extreme-trades-30-stocks-under-5.html
ibox-update will follow soon...
FDA Calendar Updates: Genzyme FDA Woes Benefit Protalix, Shire
Written by Mike Havrilla
Friday, 31 July 2009 10:05
http://biomedreports.com/articles/most-popular/3928-fda-calendar-updates-genzyme-fda-woes-benefit-protalix-shire.html
U.S. Food and Drug Administration Approves ONGLYZA (saxagliptin) for the Treatment of Type 2 Diabetes Mellitus in Adults
Thursday, 30 July 2009 22:30
http://biomedreports.com/articles/new-latest-news/3953-us-food-and-drug-administration-approves-onglyzaq-saxagliptin-for-the-treatment-of-type-2-diabetes-mellitus-in-adults.html
Consensus Forming, Spectrum Pharma (Nasdaq: SPPI) May Be Acquisition Target
Written by Justin M. Hall
Friday, 31 July 2009 23:24
http://biomedreports.com/articles/most-popular/3962-consensus-forming-spectrum-pharma-nasdaq-sppi-may-be-acquisition-target.html
PWAV - daily chart
http://www.finviz.com/quote.ashx?t=pwav&ta=1&p=d
Powerwave Technologies, Inc. - Short Interest
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol=PWAV&selected=PWAV
PWAV - Q2/2009 Earnings Call Transcript
July 31, 2009
http://seekingalpha.com/article/152989-powerwave-technologies-q2-2009-earnings-call-transcript
QUARTERLY REPORT (For the quarterly period ended June 28, 2009)
http://www.sec.gov/Archives/edgar/data/1023362/000102336209000014/q209form10q.htm
Raser Announces Jim Spellman to Lead Plug-in Hybrid Team
Date : 07/31/2009 @ 5:15PM
Source : Business Wire
http://ih.advfn.com/p.php?pid=nmona&cb=1249111156&article=38865764&symbol=NY^RZ
Raser Announces Jim Spellman to Lead Plug-in Hybrid Team
Date : 07/31/2009 @ 5:15PM
Source : Business Wire
http://ih.advfn.com/p.php?pid=nmona&cb=1249111156&article=38865764&symbol=NY^RZ
Raser Technologies, Inc. (NYSE: RZ), a leading energy technology company, said today that Jim Spellman will take over the leadership of the Plug-in Hybrid Team beginning August 1st. Patrick J. Schwartz will step down as President of Raser Technologies at the end of July 2009 to pursue other opportunities outside of Raser. Mr. Schwartz will continue his association with Raser for several months to assist with any transitional issues.
Mr. Schwartz joined the Company in 2006 and was instrumental in helping to drive the successful completion of the extended range electric vehicle (EREV) project unveiled this year at the SAE Congress in Detroit, MI, while leading Raser’s T&I business segment.
“Pat played an important role in our company’s development,” said Brent M. Cook, CEO of Raser Technologies. “We appreciate the contribution that Pat has made these past few years.”
Raser’s Vice President of the Transportation and Industrial segment, Jim Spellman, will assume Mr. Schwartz’ responsibilities. Mr. Spellman joined Raser in 2006. He has more than 20 years of engineering experience with motors in the automotive industry. Mr. Spellman came to Raser after working for Delco Remy, a former division of General Motors, for more than 27 years. Among his many responsibilities at Delco, Mr. Spellman was the director of hybrid technology.
“Jim has extensive experience in the automotive industry, which is now the focus of Raser’s T&I division. His skill set and experience are an excellent fit for the mission and direction of this part of our business,” said Cook.
NACEL Energy Announces "Snowflake" Arizona Wind Power Project and Relocation of Corporate Office to Phoenix
Date : 07/28/2009 @ 7:30AM
Source : MarketWire
http://ih.advfn.com/p.php?pid=nmona&cb=1249073793&article=38798614&symbol=NB^NCEN
NACEL Energy Announces "Snowflake" Arizona Wind Power Project and Relocation of Corporate Office to Phoenix
PHOENIX, AZ -- (Marketwire) -- 07/28/09 -- NACEL Energy Corporation (OTCBB: NCEN) (FRANKFURT: 4FC) ("NACEL Energy"), a wind power company in the business to generate clean, renewable energy, today confirmed it has entered into a long term wind development rights agreements covering 640 acres in Navajo County, Arizona. At project build-out, NACEL Energy anticipates generating 10 MW, or more, clean, renewable, wind energy at Snowflake.
The Snowflake wind energy project evidences continued, consistent application of the NACEL Energy business model -- unique in the U.S. wind industry. In brief, NACEL Energy identifies interconnection points in the nation's electric grid, and then leases nearby acreage where 6 to 18 utility class wind turbines can be constructed, without incurring the often significant transmission and related electric infrastructure upgrade costs and/or delays which can adversely impact other company's wind power projects.
NACEL Energy's Snowflake is located immediately adjacent to the first wind power facility built in Arizona, the multi-phase Dry Lake project developed by IBERDROLA Renewables, Inc. of Portland, Oregon. IBERDROLA Renewables, Inc. is the North American division of IBERDROLA Renewables, S.A., a multinational company, operating in more than 20 countries, with more than 9,600 MW of installed wind power at the end of the first half of 2009.
Through an arrangement facilitated by the landowner at Snowflake, IBERDROLA Renewables has agreed to release 15 months of wind data collected at its Dry Lake project, to NACEL Energy, for the development of Snowflake.
The wind data from Dry Lake is entirely analogous to Snowflake.
Accordingly, NACEL Energy believes its normal development timeline has been significantly shortened. Presently, NACEL Energy's work includes assessing an interconnection plan for Snowflake, which could encompass either Salt River Power, the option pursued by IBERDOLA Renewables at Dry Lake, or alternatively, Arizona Public Service. As with all NACEL Energy's projects, the Company's work at Snowflake will be announced in due course, as important milestones are achieved.
In addition, NACEL Energy announces that it is relocating its corporate offices to the Phoenix, Arizona area. The relocation of its corporate offices should be completed within the next several weeks.
NACEL Energy Chief Executive Officer, Paul Turner, Ph.D, stated:
"Snowflake is our sixth wind power project and our first outside of Texas. We look forward in the years ahead to contributing to the economy of the Phoenix region with the relocation of our corporate offices, and, upon build-out of our wind power facility at Snowflake, to contributing to the environment of Arizona by providing energy from a clean and renewable source."
Sunrise to Host Conference Call and Webcast to Discuss Second-Quarter 2009 Financial Results
Date : 07/30/2009 @ 7:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1249073643&article=38836142&symbol=NY^SRZ
Sunrise to Host Conference Call and Webcast to Discuss Second-Quarter 2009 Financial Results
MCLEAN, Va., July 30 /PRNewswire-FirstCall/ -- Sunrise Senior Living, Inc. (NYSE:SRZ) today announced that it will host a conference call and Webcast on Thursday, August 6, 2009, at 9 a.m. ET to discuss its financial results for the second-quarter 2009. Mark Ordan, chief executive officer, and Julie Pangelinan, chief financial officer, will host the call.
The call-in number for the conference call is 888-298-3451 or 719-457-1529 (from outside the U.S.). Callers should reference the "Sunrise Senior Living Q2 Earnings Call" or the participant passcode: 4727771. Those interested may also go to the Investor Relations section of the Company's Web site (http://www.sunriseseniorliving.com/) to listen to the earnings call. A telephone replay of the call will be available until August 20 at 12 p.m. ET, by dialing 888-203-1112 or 719-457-0820 (passcode: 4727771); a replay will also be available on Sunrise's Web site during that period.
nice!
20 Stocks Poised to Move Higher
Written by Justin M. Hall
Friday, 31 July 2009 05:44
http://biomedreports.com/articles/most-popular/3851-20-stocks-poised-to-move-higher.html
...@ (my) LONGTIME (OTCBB)-portfolio:
U.S. Mobile Barcode Market Poised for Growth - NeoMedia Announces First Licensing Deal with Mobile Tag
Press Release
Source: NeoMedia Technologies, Inc.
On Wednesday July 29, 2009, 7:58 am EDT
http://finance.yahoo.com/news/US-Mobile-Barcode-Market-bw-1173120023.html?x=0&.v=1
...
“This deal is a critical milestone for the industry and we’re grateful that Mobile Tag, Inc. stepped forward to work with us. It affirms that the market has realized the importance of creating a legitimate, licensed and open environment for all and I believe it marks the tipping point for rapid commercialization of mobile barcodes in the U.S.,” commented Iain McCready, CEO of NeoMedia.
“Mobile Tag, Inc. recognizes the innovation and capability enabled by the art captured in NeoMedia’s IP,” stated William J. Hoffman, CEO of Mobile Tag, Inc. “We are pleased to license with NeoMedia and believe it will spur innovation and adaptation of this technology on par with the explosion witnessed by SMS services earlier in this decade. Mobile machine readable codes will be mainstream in the U.S. just as they are in Japan, France and Poland where they are found on nearly 210 million phones. It is time to get on with it!”
...
Cell Therapeutics Initiates Procedure To Obtain Marketing Approval For Pixantrone
Published:29-July-2009
By Staff Reporter
Pixantrone, named as a New Active Substance by EMEA
http://www.pharmaceutical-business-review.com/news/cell_therapeutics_initiates_procedure_to_obtain_marketing_approval_for_pixantrone_090729
FDA Calendar Update: Cell Therapeutics
by: Mike Havrilla July 29, 2009
http://seekingalpha.com/article/152172-fda-calendar-update-cell-therapeutics?source=feed
no! ...if you don`t need it I`ll take it...
ax
...but I...
KERX -
http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-irhome
http://www.globenewswire.com/newsroom/news.html?ref=rss&&d=169198
Beacon Equity Issues Investment Report for Keryx Biopharmaceuticals Inc.
DALLAS, July 17, 2009 (GLOBE NEWSWIRE) -- BeaconEquity.com announces an investment report featuring drug development company Keryx Biopharmaceuticals Inc. (Nasdaq:KERX). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.
The investment report on Keryx Biopharmaceuticals Inc. (Nasdaq:KERX) should be of particular interest to other drug manufacturers: Novartis AG (NYSE:NVS), AstraZeneca plc (NYSE:AZN), Abbott Laboratories (NYSE:ABT) and Merck & Co. Inc. (NYSE:MRK).
It is available at: http://www.beaconequity.com/i/KERX
2009 World Stem Cell Summit (Sept. 21-23,2009)
http://www.worldstemcellsummit.com/
Suntech and China Energy Conservation Investment Corporation Partner to Develop Solar Projects
Date : 07/24/2009 @ 8:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1248438576&article=38761595&symbol=NY^STP
...BEIJING and WUXI, China, July 24 /PRNewswire-Asia/ -- Suntech Power Holdings Co., Ltd. (NYSE:STP), the world's largest crystalline silicon photovoltaic (PV) module manufacturer, announced today that Suntech has entered into a strategic agreement with China Energy Conservation Investment Corporation (CECIC) to develop solar projects over the next five years.
Through the partnership CECIC will primarily be responsible for project investment and solar project development and Suntech will supply solar products, system design and technical support. Suntech and CECIC plan to focus on the development of large scale on-grid projects, urban BIPV projects, rural off-grid projects, and wind-solar hybrid projects...
Takeover Targets: After Medarex, investors ask who's next
Written by Staff and Wire Reports
Thursday, 23 July 2009 11:22
http://biomedreports.com/articles/most-popular/2396-takeover-targets-after-medarex-investors-ask-whos-next.html
Is Raser Technologies a Bargain, Or Just Cheap?
by: Tom Konrad July 24, 2009
http://seekingalpha.com/article/151077-is-raser-technologies-a-bargain-or-just-cheap?source=feed
Is Raser Technologies a Bargain, Or Just Cheap?
by: Tom Konrad July 24, 2009
http://seekingalpha.com/article/151077-is-raser-technologies-a-bargain-or-just-cheap?source=feed
?
action today ???
SmallCapSentinel.com: Wind Energy Showcased in Fortune Magazine
* Press Release
* Source: Integrity Media
* On Tuesday July 21, 2009, 6:00 am EDT
http://finance.yahoo.com/news/SmallCapSentinelcom-Wind-pz-2538319329.html?x=0&.v=2
LAS VEGAS, July 21, 2009 (GLOBE NEWSWIRE) -- A two-page essay and promo featuring wind energy and Nacel Energy Corporation (OTCBB:NCEN - News) has been published in Fortune Magazine, a leading periodical for investors. This exposure in a publication as widely read and influential as Fortune clearly is a boon to awareness of the opportunities that exist for wind investors and Nacel. Its release, timed with a game-changing alternative energy bill heading to the Senate is also noteworthy. Additionally, Nacel made two important additions to its management team on Monday, including adding an experienced energy executive as CEO.
The report, excerpted at the link below, showcases the bright future for wind and for Nacel, which possesses an impressive portfolio of utility class wind power generation projects in Texas and three other states. Investors of the following wind power companies are encouraged to read the report: American Superconductor Corporation (Nasdaq:AMSC - News), A-Power Energy Generation Systems, Ltd. (Nasdaq:APWR - News), Florida Power & Light Company (NYSE:FPL - News), and Trinity Industries, Inc. (NYSE:TRN - News).
http://www.smallcapsentinel.com/fortune
From the report: One company that's determined to narrow that gap is Nacel Energy, a Phoenix-based wind power company. Nacel develops clusters of six to 18 utility-size wind turbines. Paul Turner, CEO of Nacel, likes what he sees on the demand side: "The momentum in wind energy is huge. I've been in the energy business for 12 years and I've never seen this level of excitement over its potential."
To capitalize on that excitement, Nacel is focusing on what Turner sees as the "macro and micro issues of wind energy." On the one hand, locating its wind turbines in parts of the country that are, well, windy. That typically means the flat, open, treeless acreage found in the Texas Panhandle and the Midwest. But, of equal importance says Turner, is placing turbines in those windy states that also require their public utilities to purchase renewable energy.
Register to receive information on this subject at http://www.smallcapsentinel.com/register
Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results. SmallCapSentinel.com is property of Integrity Media Inc. (IMI). IMI provides no assurance as to the subject company's plans or ability to effect proposed actions and cannot project capabilities, intent, resources, or experience. The subject companies haven't always approved the statements made in this report. This report is neither a solicitation to buy nor offer to sell securities and is for information purposes only and shouldn't be used as basis for investment decisions. IMI isn't an investment advisor, analyst or licensed broker dealer and this report isn't investment advice. IMI has been paid $40,000 by Before the Bell Consulting, an investor relations consultant to Nacel Energy (NCEN) for this report and other advertising services. Paid reports constitute a conflict of interest as to IMI's ability to remain objective in communication regarding subject companies. Nacel's inclusion in Fortune Magazine was paid-for by Nacel.
...sold HGSI for 305%-gain
FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB
Written by Mike Havrilla
Monday, 20 July 2009 06:20
http://biomedreports.com/articles/most-popular/2269-fda-calendar-updates-ddss-hgsi-orex-sppi-trib-.html
How Will Human Genome Evolve From Here?
07/20/09 - 01:36 PM EDT
Adam Feuerstein
http://www.thestreet.com/story/10547359/1/how-will-human-genome-evolve-from-here.html
...But clearly that was the wrong call. I was too chicken to roll the dice. Kudos to all the investors out there who bucked consensus and made a lot of money today.
Human Genome Triples on Successful Lupus Study
* By the tickerspy.com Staff
* On Monday July 20, 2009, 11:00 am EDT
http://finance.yahoo.com/news/Human-Genome-Triples-on-indie-1015902539.html?x=0&.v=1
Orexigen Will Report Phase 3 Contrave Results on Monday, July 20 (Pre-Market)
Written by Mike Havrilla
Friday, 17 July 2009 13:22
http://biomedreports.com/articles/most-popular/2241-orexigen-will-report-phase-3-contrave-results-on-monday-july-20-pre-market.html
Shares of HGSI up big in anticipation of clinical trials update
Written by M.E.Garza
Thursday, 16 July 2009 07:50
http://biomedreports.com/articles/most-popular/2206-shares-of-hgsi-up-big-in-anticipation-of-clinical-trials-update.html
Analysts feel HGSI's odds are stacked against them
Written by Staff and Wire Reports
Thursday, 16 July 2009 09:28
http://biomedreports.com/articles/most-popular/2207-analysts-feel-hgsis-odds-are-stacked-against-them.html
NACEL Energy Submits Interconnection Plan to Swisher Electric Cooperative
Date : 07/14/2009 @ 7:35AM
http://ih.advfn.com/p.php?pid=nmona&cb=1247577445&article=38628458&symbol=NB^NCEN
DENVER, CO -- (Marketwire) -- 07/14/09 -- NACEL Energy Corporation (OTCBB: NCEN) (FRANKFURT: 4FC) ("NACEL Energy"), a wind power company in business to generate clean, renewable energy, today confirmed it has submitted an "Application for Operation of Customer Owned Generation" to Swisher Electric Cooperative, Inc. (SECI) concerning the interconnection of the Company's 20 MW Swisher wind power project, to the electric grid.
SECI serves an area of 1,871 square miles in six counties in the Texas Panhandle and is part of Touchstone Energy's group of electric cooperatives. NACEL Energy's complete submission to SECI included requisite engineering drawings, wind turbine selection and proposed date of commissioning (operations).
As NACEL Energy previously confirmed on January 21st, 2009, an NRG Systems meteorological tower was erected at Swisher, which comprises 1573 acres in Donley County, Texas. According to the Texas State Energy Conservation Office (SECO), the Texas Panhandle exhibits the State's "greatest expanse of high quality winds." Last quarter, the Company commissioned an interim analysis of site wind data collected at Swisher and results met expectations.
NACEL Energy identifies interconnection points in the nation's electric grid, and then leases nearby acreage where 6 to 18 utility class wind turbines can be constructed without incurring the often significant transmission and related electric infrastructure upgrade costs and delays which can adversely impact other company's wind power projects. The Company's work in this regard is currently focused in Texas, Arizona, Kansas and Illinois.
NACEL Energy anticipates a period of several months, or longer, before a final interconnection agreement can be executed with SECI. In the interim, important additional development milestones are underway including, without limitation, obtaining turbine debt financing and a power purchase agreement. Accordingly, the Company cautions that commissioning (operations) at Swisher is not expected until July 2010, or later depending on future events.
NACEL Energy Chief Executive Officer, Brian Lavery, stated:
"With our submission of an Interconnection Plan coupled with delivery of engineering drawings and other requisite documentation to SECI, as confirmed today, we are able to confirm that the pace of development at Swisher is proceeding satisfactorily and as contemplated by the Company."