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Mooi instap moment Dendreon

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  1. [verwijderd] 10 januari 2007 22:25
    Psycho heb jij een link naar RT-koers Dendreon aub,het wordt nu wel heel spannend,het gaat nu mooi met de ID SMA mee in de golf,mooie spurt.

    RB
  2. [verwijderd] 10 januari 2007 22:30
    quote:

    snor13854 schreef:

    Psycho heb jij een link naar RT-koers Dendreon aub,het wordt nu wel heel spannend,het gaat nu mooi met de ID SMA mee in de golf,mooie spurt.

    RB
    Snor, ik gebruik Tradebox van ABN. Maar Arca is zo te zien weer normaal beschikbaar. Daar is RT, maar je krijgt alleen een idee van de prijs. Trouwens, voor die 15 euri per maand zou ik gewoon Tradebox nemen met veel Nasdaq fondsen.

    Psycho
  3. [verwijderd] 12 januari 2007 12:26
    Kunnen we vandaag nieuws m.b.t. de review verwachten of wacht Dendreon met het uitgeven van een PR tot volgende week vrijdag de 19e ivm aflopen call opties?

  4. [verwijderd] 15 januari 2007 09:31
    wachten is dus op nieuws.

    Slecht nieuws => koers -50%
    Goed nieuws => koers +10%

    Bij slecht nieuws kan je het aandeel toch gewoon bijkopen omdat het alleen uitstel vaneen ½ jaar betekend?
  5. [verwijderd] 15 januari 2007 14:52
    quote:

    tuttebollekakkie schreef:

    wachten is dus op nieuws.

    Slecht nieuws => koers -50%
    Goed nieuws => koers +10%

    Bij slecht nieuws kan je het aandeel toch gewoon bijkopen omdat het alleen uitstel vaneen ½ jaar betekend?
    klopt, verwacht ook zeker geen -50% bij geen priority review, idd alleen vertraging dan in beoordeling en verwacht zelfs gewoon priority review ivm dodelijke aandoening

    begin febr ergens ook FDA panel presentatie over kanker behandeling mogelijkheden (oa vaccins)
  6. [verwijderd] 16 januari 2007 14:05
    Dendreon's PROVENGE Granted FDA Priority Review for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
    Tuesday January 16, 8:00 am ET
    FDA Accepts PROVENGE Biologics License Application

    SEATTLE, Jan. 16 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and has assigned priority review status to the Company's Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.

    ADVERTISEMENT
    Priority Review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. The goal for reviewing a product with Priority Review status is six months from the filing date. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the PROVENGE BLA is May 15, 2007.

    "Clinical trials have shown that PROVENGE increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options," said Mitchell H. Gold, president and chief executive officer of Dendreon. "We are extremely pleased the FDA has granted priority review to PROVENGE, which may represent an important new treatment option for men suffering from prostate cancer."

    Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

    The BLA submission is based primarily on an improvement in overall survival observed in Study D9901, a multi-center, randomized, double-blind, placebo-controlled Phase 3 Study, the results of which were published in the July issue of the Journal of Clinical Oncology.

    About PROVENGE

    PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

    About Dendreon

    Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has headquarters in Seattle and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.

    Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

  7. [verwijderd] 16 januari 2007 14:31
    heb vorige week net de helft verkocht op 4.04.
    nog 4000 te gaan.

    met dank aan omg, de aanstichter van mijn koop.

    de aanstichter vd verkoop was ik zelf.


  8. [verwijderd] 16 januari 2007 14:31
    quote:

    tuttebollekakkie schreef:

    Shit, had ik u toch maar bijgekocht.
    kan hierop was helemaal niet 100%
    Eerder 50/50
    Ben benieuwd naar de koers deze week.

    Ik heb vorige week goed getankt aan 4 dollar ... :-D
  9. [verwijderd] 16 januari 2007 14:35
    Zo, is het niet linksom met de geiten dan maar rechtsom :-). Jij ook veel plezier met je winst connect.
    Biertje? (Op yahoo roepen ze al $ 200 over 2 jaar).
    Met de helft ben ik ook wel tevreden :-).
  10. [verwijderd] 16 januari 2007 14:59
    Dendreon's PROVENGE Granted FDA Priority Review for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer

    -- FDA Accepts PROVENGE Biologics License Application --

    SEATTLE, WA, January 16, 2007 - Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and has assigned priority review status to the Company's Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.

    Priority Review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. The goal for reviewing a product with Priority Review status is six months from the filing date. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the PROVENGE BLA is May 15, 2007.

    "Clinical trials have shown that PROVENGE increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options," said Mitchell H. Gold, president and chief executive officer of Dendreon. "We are extremely pleased the FDA has granted priority review to PROVENGE, which may represent an important new treatment option for men suffering from prostate cancer."

    Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

    The BLA submission is based primarily on an improvement in overall survival observed in Study D9901, a multi-center, randomized, double-blind, placebo-controlled Phase 3 Study, the results of which were published in the July issue of the Journal of Clinical Oncology.

    About PROVENGE

    PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

    About Dendreon

    Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has headquarters in Seattle and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.

    Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for
    which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    Contact:
    Monique Greer
    Sr. Director, Corporate Communications
    Dendreon Corporation
    (206) 829-1500
  11. [verwijderd] 16 januari 2007 15:03
    quote:

    Ksm00225 schreef:

    [quote=tuttebollekakkie]
    Shit, had ik u toch maar bijgekocht.
    kan hierop was helemaal niet 100%
    Eerder 50/50
    Ben benieuwd naar de koers deze week.

    [/quote]

    Ik heb vorige week goed getankt aan 4 dollar ... :-D
    was geen 50/50
    was 90/10 kans op priority review

    waarom?
    had al fast track status en gaat om dodelijke ziekte
  12. [verwijderd] 16 januari 2007 15:33
    quote:

    ohmygod schreef:

    Zo, is het niet linksom met de geiten dan maar rechtsom :-). Jij ook veel plezier met je winst connect.
    Biertje? (Op yahoo roepen ze al $ 200 over 2 jaar).
    Met de helft ben ik ook wel tevreden :-).

    doe me eerst maar een biertje.
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