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Mooi instap moment Dendreon

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  2. [verwijderd] 29 april 2010 18:55

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    Ja!

    www.reuters.com/article/idCNWBT013882...

    U.S. FDA clears Dendreon's prostate cancer vaccine
    Thu Apr 29, 2010 12:49pm EDTStocks
    Dendreon Corp
    DNDN.O
    $45.50
    +5.88+14.84%5:34pm UTC+0200
    WASHINGTON, April 29 (Reuters) - Dendreon Corp (DNDN.O) won U.S. approval on Thursday to sell a vaccine to treat men with advanced prostate cancer and the company's shares soared 15 percent.

    The Provenge vaccine is the first vaccine to treat any type of cancer. The Food and Drug Administration said in a statement Provenge offered a new option to men with advanced prostate cancer who have limited options. (Reporting by Lisa Richwine, editing by Maureen Bavdek)
  4. [verwijderd] 29 april 2010 19:49

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    Van de FDA site.

    FDA NEWS RELEASE

    For Immediate Release: April 29, 2010
    Media Inquires: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov

    FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

    The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

    Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

    Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

    “The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

    Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

    The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

    Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

    Provenge is manufactured by Seattle-based Dendreon Corp.

    www.fda.gov/NewsEvents/Newsroom/Press...

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  7. flosz 30 april 2010 13:36

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    Drie dikke zoenen voor psycho, hartelijk gefeliciteerd!
    Btw: af en toe even wuiven naar dr. Scherr.
  11. flosz 4 mei 2010 19:40

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    Last Thursday Dendreon’s much-debated prostate cancer therapy, Provenge, was approved. And company insiders were able to celebrate properly, thanks to a flurry of subsequent stock sales that scored them millions, the WSJ reports.
    President and CEO Mitchell Gold saw more than $28 million in proceeds after exercising options on shares and selling them on Thursday, and selling more shares later, SEC filings show. (The total amount required to exercise the options was just over $2 million.) He still owns 224,359 shares.
    Richard Hamm Jr., senior vice president and general counsel, also sold shares, reaping proceeds of $14.3 million. The company’s CFO, Gregory Schiffman, had $3 million in sale proceeds, and a director, Susan Bayh, netted nearly $2.5 million after exercising options and then selling shares. (Bayh, who is on numerous corporate boards, is married to Evan Bayh, the Indiana senator who said this year he won’t seek re-election.)
    The WSJ reports Dendreon didn’t respond to phone calls and an email late Monday. If we hear from them today, we’ll let you know.
    As longtime Health Blog readers may recall, Gold sold Dendreon shares in 2007 after an FDA advisory panel voted to recommend it. In May of that year, the FDA requested more information and data from the company. Its shares plunged.
    blogs.wsj.com/health/2010/05/04/dendr...
  16. [verwijderd] 6 juni 2010 23:33

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    quote:

    ludwig mack schreef:

    hebben jullie winst al gepakt of wachten jullie nog ........
    gr
    Ik heb ze nog maar vraag me wel af waar ik nog op moet wachten......
  18. [verwijderd] 1 juli 2010 02:22

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    DNDN krijgt een oplawaai van om en bij de -18%

    Nu nabeurs nog op $26,69 (-17,45%) met een low van $24,51.

    After Hours Volume: 5,031,344

    Read more: www.nasdaq.com/aspxcontent/ExtendedTr...

    Deze overdreven? reactie komt er na dit nieuws.

    Dendreon Plunging After Hours (DNDN)

    Shares of Dendreon (NASDAQ: DNDN) are plunging in the after hours session on news that the Center for Medicare & Medicaid Services (CMS) has opened a national coverage determination to "determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act."

    This appears to be a Medicare/Medicaid reimbursement issue as it relates to Provenge treatment costs. If CMS determines that Provenge is both reasonable and necessary, then patients will be reimbursed. If not, Provenge treatment, which costs $93,000 for a full course, will not be covered.

    The shares have currently lost more than 18% to $26.50 in the late trading session. According to the press release at cms.gov, "CMS received informal inquiries for a national coverage determination (NCD) for autologous cellular immunotherapy treatment of prostate cancer. This interest arose upon the recent FDA approval of the Sipuleucel T treatment regimen, marketed as Provenge®."

    The formal request was accepted and review initiated today, and the press release gives the "Expected NCA Completion Date" as 6/30/2011. There will be a public comment period starting today, which will last a month.

    www.dailyfinance.com/related/dendreon...

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  19. [verwijderd] 1 juli 2010 15:08

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    Er zullen zich weer vele beleggers bekocht voelen na wat zich nabeurs heeft afgespeeld.

    Pre-Market Last:

    Net / % Change $ 28.18 -4.15 (-12.84%) Pre-Market High: $ 28.46
    Pre-Market Volume: 1,280,892
    Pre-Market Low: $ 26.74

    DNDN staat nu al bol van het nieuws.

    #
    Thursday, July 01, 2010
    #
    Morgan Joseph Lowers Estimates On Dendreon (DNDN), Sees Pricing Cuts
    8:45:27 AM View all Related Articles > | StreetInsider.com

    #
    Dendreon weakness creates buying opportunity, says Rodman & Renshaw
    8:40:18 AM | Theflyonthewall.com
    #
    The Twitter-24/7 Wall St. Stock Market Report 7.1.2010 The Wisdom Of Crowds
    8:26:06 AM | 24/7 Wall Street
    #
    Dendreon weakness an overreaction, says Canaccord
    8:18:10 AM | Theflyonthewall.com
    #
    Leerink: Unlikely CMS will not cover Dendreon's Provenge
    7:48:06 AM | Theflyonthewall.com
    #
    Dendreon volatility elevated; government begins Provenge analysis
    7:37:34 AM | Theflyonthewall.com
    #
    Dendreon makes statement on CMS National Coverage Analysis
    6:11:53 AM | Theflyonthewall.com

    www.dailyfinance.com/headlines/dendre...

    $ 28.35 -3.98 (-12.31%)

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