is...wondering why God loves us so much?
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Well said DFLY, also, it's important to ask the question:
1) Why would a company, (BLLD), with the intent on posting a RS, not dilute it's pps to .0001 in the first place? THAT'S THE MILLION DOLLAR QUESTION.
2) It can be well inferred that the 60% drop was not in fact insiders, but investors who did not want any part in a RS to begin with, b/c if in fact it was insiders, we would not have closed @ .0065 rather, .0001.
No, i'll take it day by day, and add what i can fetch up.
Ladies/Gents,
Im looking forward to the events NXTN has in store. I'd like to assist in updating the IBOX. If so, let me know.
Thanks,
amazing volume!!
thanks NS!!
BLLD tank - 60%
def!!!!
agree - it was 5050 either way, gamble it in vegas no tax.
Sigh griff.....
Prolia: (AMGEN)
Prolia(R) (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire via COMTEX/ --
Amgen (Nasdaq: AMGN) today announced new long-term data showing that during the fourth and fifth years of Prolia(R) (denosumab) treatment, postmenopausal women with osteoporosis receiving Prolia continued with further, statistically significant, year-over-year increases in lumbar spine and total hip bone mineral density (BMD), a key measurement of bone strength. The overall adverse event profile was similar for the fourth and fifth years of consecutive Prolia treatment.
The data, which were presented at the annual European Congress Osteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain, showed that treatment with Prolia, the first and only approved RANK Ligand inhibitor for the treatment of postmenopausal osteoporosis, resulted in robust BMD gains after five continuous years of treatment (13.7 percent for lumbar spine BMD and 7.0 percent for total hip BMD).
The FREEDOM Study and the 5-Year Prolia Data
The pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) study established the efficacy and safety of Prolia based on three years of data from approximately 7,800 postmenopausal women. The open-label extension of FREEDOM is evaluating the long-term (up to 10 years) efficacy and safety of Prolia in 4,550 postmenopausal women. Seventy percent of eligible women from the FREEDOM study continued enrollment in the extension study; 2,343 women continued to receive Prolia treatment, and 2,207 transitioned from placebo to Prolia.
Continued treatment with Prolia resulted in consistent year-over-year gains in BMD at the lumbar spine and total hip. In years 4 and 5 respectively, women taking Prolia experienced further 1.9 percent and 1.7 percent increases in lumbar spine BMD and further 0.7 percent and 0.6 percent increases in total hip BMD (all P<0.0001 compared with extension baseline).
The incidences of new osteoporotic fractures also remained low for women taking Prolia for five years.
The women who transitioned from placebo to Prolia in the extension study showed significant BMD increases during the first two years of Prolia treatment: 7.9 percent increase in lumbar spine BMD and 4.1 percent increase in total hip BMD (all P<0.0001 compared with extension baseline).
Rates of adverse events (AEs) were 83.4 percent for women who continued on Prolia and 82.8 percent for women transitioned from placebo to Prolia. Rates of serious AEs were 18.9 percent and 19.4 percent for the two groups respectively. Two subjects in the group that transitioned from placebo to Prolia had AEs adjudicated to osteonecrosis of the jaw (ONJ) that healed without further complications. One of these subjects continued Prolia, and one subject discontinued. No atypical femoral fractures were reported in either group.
Osteoporosis: Impact and Prevalence
Referred to as a "silent epidemic" by the International Osteoporosis Foundation (IOF), osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization has officially declared osteoporosis a public health crisis, and the IOF is urging governments worldwide to make osteoporosis a healthcare priority.
Osteoporosis-associated fractures are a significant cause of mortality and morbidity. In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures.(1) Since 2001, the incidence of hip fractures in European countries has risen significantly.(2) In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than three million by 2025.(3)
The direct medical cost of osteoporotic fractures in Europe is expected to rise from euro 31.7 billion in 2000 to euro 76.7 billion in 2050.(4) In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025.(5)
About Prolia
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia is available in 12 European countries, the U.S., Canada and Australia. Applications in the rest of the world are pending.
Prolia is administered as a single subcutaneous injection of 60mg once every six months. For further information on Prolia, please visit: www.prolia.com.
Important EU Safety Information
The most common adverse reactions with Prolia were urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremity. The most serious adverse reactions were those of skin infections, predominantly cellulitis, reported more commonly in the Prolia group compared with placebo (0.4 percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions of skin infection were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in patients with prostate cancer receiving ADT, an imbalance in cataract adverse events was observed with Prolia compared with placebo (4.7 percent vs. 1.2 percent). No imbalance in cataract adverse events was observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
Prolia may lead to hypocalcaemia. Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. ONJ has been reported rarely in clinical studies in patients receiving denosumab at a dose of 60 mg every 6 months for osteoporosis.
Important U.S. Safety Information
Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D.
In the pivotal study, serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the Prolia-treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes, and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.
Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as ONJ, atypical fractures, and delayed fracture healing. ONJ has been reported in patients with Prolia. Patients should be monitored for these adverse outcomes. The most common adverse reactions (> 5 percent and more common than placebo) were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Pancreatitis has also been reported with Prolia.
Denosumab Commercialization Collaborations
In July 2009, Amgen and GlaxoSmithKline announced a collaboration agreement to jointly commercialize Prolia for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialize Prolia's postmenopausal osteoporosis and potential oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
In addition, GlaxoSmithKline will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea but excluding Japan. The structure of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future.
Amgen and Daiichi-Sankyo Company Limited have a collaboration and license agreement for the development and commercialization of denosumab in Japan.
About Amgen
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of March 23, 2011 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
Editor's Note: Prolia(R) (denosumab) currently is not commercialized in Spain.
CONTACT: Amgen, Thousand Oaks
Ashleigh Koss: (805) 313-6151 (U.S. media)
Wendy Woods Williams: +41 (41) 3692 542 (E.U. media)
Arvind Sood: (805) 447-1060 (investors)
(1) "Facts and statistics about osteoporosis and its impact." International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-22 on 4 February 2011
(2) "Osteoporosis in the European Union in 2008: Ten years of progress and ongoing challenges." Accessed at http://www.iofbonehealth.org/publications/eu-policy-report-of-2008.html on 4 February 2011
(3) Burge R, et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007: 22::465-475
(4) "Facts and statistics about osteoporosis and its impact." International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/facts-and-statistics.html on 4 February 2011
(5) "Fast Facts" National Osteoporosis Foundation. Accessed at http://www.nof.org/node/40 on 4 February 2011
(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)
SOURCE Amgen
well, here's lower
geez Dan, your 2nd post on here and you're bashing?
CMEY - how does a stock drop 80% in the AM and release such good news late trading?
that's a night at the a fancy hotel in the nyc with room service!!!
you animal :-P lol nj
cool beans !
good luck griff, Thursday is earnings keep in mind.
insane! nice alert mo!
you would think it's overexaggerated no?
Griff, im sorry- you're right - They lowered guidance that day!!! it wasn't earnings...
they started declining since their earnings (TLB) it was trading @ roughly $9 then!!! ho humm...
TLB, 52 wk Low. 4.44
JOEZ, 52 wk low - .83
misleading - we may repurchase:
GSE may, from time to time and depending on market conditions, share price and other factors, acquire shares of its common stock on the open market or in privately negotiated transactions up to an aggregate purchase price of $3.0 million.
Saba7 el Morning
Fed - More news Posted:
GSE Systems Announces $3 Million Share Repurchase Program
G S E (AMEX:GVP)
Intraday Stock Chart
Today : Tuesday 22 March 2011
GSE Systems, Inc. (“GSE” or “the Company”) (NYSE Amex: GVP), a global energy services solutions provider, today anounced that its Board of Directors has authorized a share repurchase program under which GSE may, from time to time and depending on market conditions, share price and other factors, acquire shares of its common stock on the open market or in privately negotiated transactions up to an aggregate purchase price of $3.0 million. The share repurchase program has no expiration date. GSE currently has 19,224,031 shares of common stock outstanding.
Jim Eberle, Chief Executive Officer of the Company, commented, “This share repurchase plan reflects our confidence in the long-term prospects of our business and industry. We are also fortunate to be supported in our endeavors by a strong financial position. At December 31, 2010, we reported cash and equivalents of $26.6 million, or $1.40 per diluted share, no long-term debt, operating cash flows of $2.4 million, and a backlog of $55.9 million. In light of these factors, we believe that this plan is both a prudent use of capital and an additional avenue to create long-term value for our stockholders.”
GM SSS!!!
not sure, they had tanked when the posted earnings last week; had them on watch but this news is came across today. i'll research more.
Guys, can someone elaborate on this ?
GSE Systems Announces Corporate Action
4:10p ET March 21, 2011 (Business Wire)
GSE Systems, Inc. ("GSE" or "the Company") (NYSE Amex: GVP), a global energy services solutions provider, announced that its Board of Directors today adopted a Stockholder Protection Rights Agreement and declared a distribution of one Right on each outstanding share of the Company's common stock to stockholders of record at the close of business on April 1, 2011. The Rights Agreement was adopted to provide protection to the Company's stockholders and to enable the Board to discharge its duties to all stockholders. The Rights Agreement was not adopted in response to any specific proposal to acquire the Company.
In general, the Rights become exercisable if any person or group acquires 20% or more of the Company's common stock. The Rights are designed to cause dilution to any such acquiring person or group by permitting the holders of the Rights, other than such acquiring person or group, to purchase from the Company $16.00 of the Company's common stock for $8.00, subject to certain exceptions. Until the Rights become exercisable, they will not be evidenced by separate certificates and will trade automatically with shares of the Company's common stock. The Rights will expire on March 21, 2014, unless extended.
Jim Eberle, Chief Executive Officer of the Company, commented, "The Rights Agreement is intended to promote the fair and equal treatment of the Company's stockholders and deter any potential coercive takeover tactics that could be used to deprive stockholders of the full, long-term value of their investment. The Board is committed to acting in the best interests of all its stockholders."
ABOUT GSE SYSTEMS, INC.
GSE Systems, Inc. provides a wide range of simulation and training solutions to the global energy (nuclear and non-nuclear) industry, and is the world leader in nuclear simulation. The Company has over three decades of experience, more than 1,100 installations, and over 160 customers in 48 countries. Our software, hardware and integrated training solutions leverage proven technologies to deliver real-world business advantages to the energy, process, manufacturing and government sectors worldwide. GSE Systems is headquartered in Sykesville (Baltimore), Maryland, with offices in St. Marys and Augusta, Georgia; Tarrytown, New York; Madison, New Jersey; Chennai, India; Nykoping, Sweden; Stockton-on-Tees, UK; and Beijing, China. Information about GSE Systems is available via the Internet at http://www.gses.com.
FORWARD LOOKING STATEMENTS
We make statements in this press release that are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. These statements reflect our current expectations concerning future events and results. We use words such as "expect," "intend," "believe," "may," "will," "should," "could," "anticipates," and similar expressions to identify forward-looking statements, but their absence does not mean a statement is not forward-looking. These statements are not guarantees of our future performance and are subject to risks, uncertainties, and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties, and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
SOURCE: GSE Systems, Inc.
GSE Systems Inc.
Jim Eberle
Chief Executive Officer
410-970-7950
or
The Equity Group Inc.
Devin Sullivan
Senior Vice President
212-836-9608
dsullivan@equityny.com
very true - and I want more of it!!! Are you praying for Japan HW ?
VVV is good enough :) - therapeutic enough. We turned it into a Church not too long ago lolz
I've been meaning to message you too I saw your post in the therapy room :) we need to energize that room.
I'm alright HW - AXLX on the other hand - PUKE!
How the heck did this tank to 3 cents earlier today - It was just at 12 cents not long ago!!!!! Not looking good into next week - at this rate - subpenny?
Great Post!
NJ - Cintrix :)
Yes, good for both opportunity and ill-made decisions - choose wisely.
WELCOME BACK MM VVV !!!!!!!!!!!
SBAY - There she goes...