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Mooi instap moment Dendreon

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  2. [verwijderd] 19 december 2006 16:46

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    quote:

    snor13854 schreef:

    Heb net een flink aantal DNDN ingekocht,ziet er goed uit, met een aanloop tot mei.

    RB
    4,10 sterke support
    3,97 ook
    daarna 3,78

    tijd begint te dringen idd ook voor de shorts
    die shorten ook niet meer kaal
    gister flink groot call optie volume bij de daling
  3. [verwijderd] 19 december 2006 17:03

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    Posted as a reply to msg 22209 by skcotswonki

    DNDN Milestones Reposts - Thanks Skcots!
    Worth a Repost

    Original Message: by skcotswonki on 12/19/2006 9:24:48 AM

    Now this is just what has been announced. As the positive announcements and positive surprises keep coming, it is obvious good things happen at Dendreon and we find out later. Soon we will find out about a ROW partner and the FDA.

    Of course, if one judges performance by the ability of the CEO to shake and break an illegal cartel of shorts who have bought off or intimidated analysts and reporters and are willing to sell an unlimited number of shares short without fear of repercussions or prosecution, then yes, so far Gold has not done this.

    But Gold is still holding his two most valuable trump cards and will soon lay them down, FDA approval of Provenge and a multi-billion dollar ROW partnership deal. And you have to be in the stock before the announcements, which are coming sooner than expected.

    Here is what I see just for 2006:

    Hired 30 year biotech veteran Mary Y. Coon as vice-preisident of quality:

    investor.dendreon.com/ReleaseDetail.c...

    Hired Ernest Bognar as general manager of the manufacturing facility in NJ. He was senior director of commercial manufacturing for ImClone Systems Inc., where he managed a biopharmaceutical start-up operation that produced the company's monoclonal antibody, ERBITUX® (cetuximab) Injection for the treatment of colorectal cancer:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon Names Christopher Lockett Head of Government Affairs after spending 17 years at TAP Pharmaceuticals where he was the liason with the Centers for Medicare and Medicaid for Lupron:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon presented pre-clinical data for CA9 where in animal models 40 percent of the animals in the drug arm alive at the end of the study compared to zero percent of the animals in the control arm (p-value = .008):

    investor.dendreon.com/ReleaseDetail.c...

    Published Phase II study P-16 of PROVENGE® (sipuleucel-T) active cellular immunotherapy for prostate cancer in combination with Avastin® (bevacizumab) in the July issue of the American Cancer Society's journal, Cancer:

    investor.dendreon.com/ReleaseDetail.c...

    Published the results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in the July issue of the Journal of Clinical Oncology:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon completed construction of its manufacturing facility in NJ:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon Submited Clinical and Non-Clinical Sections of Rolling BLA to FDA for PROVENGE to Treat Advanced Prostate Cancer Patients:

    investor.dendreon.com/ReleaseDetail.c...

    Announced PROVENGE Significantly Extends Prostate Cancer Specific Survival in Advanced Prostate Cancer:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon announced data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) that showed a significant correlation between cumulative CD54 upregulation and survival for patients treated with Dendreon's investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with advanced androgen-independent (hormone refractory) prostate cancer:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon announced positve reults from its phase III P-11 trial of Provenge in earlier stages of prostate cancer:

    investor.dendreon.com/ReleaseDetail.c...

    The abstract, entitled "Defining the Optimal Role of Immunotherapy and Chemotherapy: Advanced Prostate Cancer Patients Who Receive Sipuleucel-T (PROVENGE) Followed by Docetaxel Derive Greatest Survival Benefit," was presented at the Chemotherapy Foundation Symposium in New York by Daniel Petrylak, M.D., associate professor of medicine at the New York-Presbyterian Hospital at the Columbia University Medical Center:

    investor.dendreon.com/ReleaseDetail.c...

    Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer:

    investor.dendreon.com/ReleaseDetail.c...

    Announced Greg T. Schiffman joined Dendreon as senior vice president and CFO from Affymetrix Inc., where he served as CFO and executive vice president for the last five years:

    investor.dendreon.com/ReleaseDetail.c...


  6. [verwijderd] 19 december 2006 17:12

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    Op 4.17,maakt me geen bal uit of dat nu ook voor 4.00 kan,eerste positie is gewoon 4.17,op een goedkope dollar,koop bij als het naar 3.80 gaat,maar dat zit er niet in,beleggers zien echt wel toekomst in een produkt,wat bij goede testresultaten,als een raket gaat,te weten prostaat kanker,een wereld probleem??

    RB
  7. [verwijderd] 19 december 2006 19:23

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    quote:

    snor13854 schreef:

    Op 4.17,maakt me geen bal uit of dat nu ook voor 4.00 kan,eerste positie is gewoon 4.17,op een goedkope dollar,koop bij als het naar 3.80 gaat,maar dat zit er niet in,beleggers zien echt wel toekomst in een produkt,wat bij goede testresultaten,als een raket gaat,te weten prostaat kanker,een wereld probleem??

    RB
    Ze doen allezins straf hun best om de 4.10 te slopen! Van mij moeten ze niet wachten met de melding van priority revieuw
  9. [verwijderd] 19 december 2006 19:33

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    quote:

    DieGroeneGigant schreef:

    print.chartnet.nl/Show.cgi?Img=37993B...
    A) je hebt de gebroken uptrend gemist tpv de stijging voor de dilution
    b)3,73 ultieme bodem, mis je ook (evt 3,68 intraday)
    c) CCI/williams zou je eens erbij moeten betrekken, goede indicatoren

    je charts kloppen de laatste tijd niet goed, je trendkanalen kloppen niet en zijn te algemeen
    hoop niet dat je erop swingtrade

  12. [verwijderd] 19 december 2006 20:43

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    8k out

    Item 1.01. Entry into a Material Definitive Agreement.
    On December 14, 2006, Dendreon (the “Company”) announced that Gregory T. Schiffman has joined the Company as senior vice president and chief financial officer. An Executive Employment Agreement, entered into with Mr. Schiffman, provides him an annual base salary of $360,000. If targets agreed in advance by the Board of Directors are met, Mr. Schiffman is eligible for a bonus as determined by the Board of up to 40% of his base salary. In addition, the agreement provides for the granting of 200,000 shares in restricted stock, granted under the terms of our 2000 Equity Incentive Plan (the “Plan”) on his first day of employment.
    The agreement has no specified term, and the employment relationship may be terminated by Mr. Schiffman or by us at any time. If we terminate his employment without cause, or if he resigns for good reason, as such terms are defined in the agreement, Mr. Schiffman will be entitled to a lump sum severance payment equal to nine months of his then current base salary plus 75% of his maximum annual bonus for such year. In that event, Mr. Schiffman would also be entitled to full accelerated vesting of any unvested stock options and any unvested restricted stock held by him. The agreement requires Mr. Schiffman not to compete with us after termination of employment for a period of nine months, and provides a one-year post-termination non-solicitation obligation.
    Also on December 18, 2006, we entered into an indemnity agreement with Mr. Schiffman substantially similar to those that we currently have in place with our directors, other executive officers and certain other members of senior management. The indemnity agreement provides, among other things, that we will indemnify Mr. Schiffman, under the circumstances and to the extent provided for in the agreement, for expenses, damages, judgments, fines and settlements he may be required to pay in actions or proceedings in which he is or may be made a party by reason of his position as an officer or other agent of the Company, and otherwise to the full extent permitted under Delaware law and our Bylaws.

    Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
    In a special telephonic meeting held on November 13, 2006, our Board of Directors approved the appointment of Gregory T. Schiffman as our Senior Vice President, Chief Financial Officer and Treasurer, and designated him as one of our executive officers.


  14. [verwijderd] 19 december 2006 22:08

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    quote:

    connect schreef:

    360.000 dollar voor de nieuwe cfo, en 200.000 aandelen.

    zal wel een drukke baan zijn met zo'n omzet.
    Had er op zijn vorige job wel 750.000 per jaar, moet er dus toch wel iets in zien
  15. [verwijderd] 20 december 2006 01:14

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    This is a repost Ranchero did a few days ago on the trials.

    Msg: 21694 of 22466 12/15/2006 3:26:25 PM Recs: 39 Sentiment: Strong Buy
    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 21594 by rdh19869
    Re: A quick? look at Provenge's Clinical Trial History

    1. Phase 2 Immune Monitoring and Cell Count: “The T cell proliferation to the fusion protein were maximal after either two or three infusions of Provenge. For the cohort of 12 patients , the response was significantly higher at week 4 compared with week 0 (p<.01), and at week 8 compared to week 4 (p<.05), but not at week 12 compared with week 8. The dose of Provenge infused did not correlate with the magnitude of T cell response.” at p 3898. “The relationship between the development of a T cell or B cell immune response to PAP (seminal fluid derived) and the time to disease progression was evaluated (Fig. 5). The median time to disease progression was 34 weeks for patients who developed an immune response (n=20) compared to 13 weeks for patients who did not (n=11) (p<0.027).” “The relationship between the time to diseases progression and the average dose of dendritic cells received by each patient was also examined. Inspection of the data revealed that all patients who experienced disease progression more than 24 weeks after registration received average cell doses above 100 x 10 to the sixth cells/infusion. The median time to disease progression was 31.7 weeks for patients who received more than 100 x 10 to the sixth cells/infusion, compared with 12.1 weeks for patients who received fewer cells. (Fig. 6). The difference between the two groups was statistically significant (p=0.013).” at p3899. Provenge Phase 2 Clinical Trial Report: Immunotherapy of Hormone-Refractory Prostate Cancer With Antigen-Loaded Dendritic Cells By Eric J. Small, Paige Fratesi, David M. Reese, George Strang, Reiner Laus, Madhusudan V. Peshwa, Frank H. Valone Journal of Clinical Oncology, Vol 18, Issue 23 (December), 2000: 3894-3903 www.jco.org/cgi/content/full/18/23/3894

    2. Phase 3 Immune Monitoring and Cell Count:”Adequate sample collection for immunology testing was avaiable for 49 patients; 18 treated with placebo(40% of total), 31 treated with sipuleucel-T (38% of total). The PA2024 T-cell stimulation index is a measure of specific T cell responsiveness against the target antigen. This exploratory analysis was performed for a subset of patients for whom cells could be processed within 24 hours of collection, thus precluding the need to freeze the cells before analysis. All analyses were performed before study unblinding. The median ratio of the T-cell index at 8 weeks vs. baseline (pre-infusion) was approximately eightfold higher in sipuleucel-T versus placebo treated patients(16.91 Wilcoxon vs. 1.99; Wilcoxon rank sum P<0.001)” at p.3092. “For each of the sipuleucel-T infusions, the number of cells infused was the maximum number of cells that could be prepared from the leukapherisis product; the median number of nucleated cells per infusion was 3.65 x 10 to the ninth and the median number of CD54+ bright cells per infusion was 7.45 x 10 to the eigth.” At p. 3090 Results of a Placebo-Controlled Phase III Trial of Immunotherapy with APC8015for Patients with Hormone Refractory Prostate Cancer (HRPC) E. J. Small, P. F. Schellhammer, C. S. Higano, J. Neumanaitis, F. Valone, R. Hershberg www.asco.org/portal/site/ASCO/menuite...
    61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=34&abstractID=31910

    3. Thus, the Ph1/2 T cell proliferation sampling set three as the initial optimal dosing. The potency of Phase 3 Provenge as measured by cell count was far higher than Phase 2, so the Phase 2 data indicated that the TTP endpoint should have been easily statistically significant. The Cumulative CD54 upregulation Provenge potency measure comparing those treated patients above median with those below has now been found to be statistically significant for increased survival. Dr. Provost’s 2/9/06 presentation to the FDA CBER Advisory panel has been updated by the Dendreon Potency Assays Presentation of Poching Liu: www.celltherapysociety.org/files/PDF/...

    4. It is ironic that, quoting Dr. Petrylak: "The results of this analysis suggest that the use of PROVENGE as a first-line treatment followed by the chemotherapy docetaxel upon disease progression may provide patients with a substantially prolonged survival benefit." The 9901 and 9902a data suggests that this benefit is far greater than that for either Taxotere or Provenge alone. biz.yahoo.com/prnews/061110/sff019.ht...

    5. It is becoming clear that until better adjuvants come along, the unpleasant side effects of chemo have not been dispatched as of yet. One indication of this is that Dr. Elizabeth Jaffee of John Hopkins, the author of a well regarded review of using chemos with vaccines (See: Review Articles Leveraging the Activity of Tumor Vaccines with Cytotoxic Chemotherapy Leisha A. Emens1 and Elizabeth M. Jaffee1,2,3,4 Departments of 1 Oncology, 2 Immunology, 3 Pathology, and 4 Pharmacology, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland Cancer Research 65, 8059-8064, September 15, 2005 cancerres.aacrjournals.org/cgi/conten... ) has been asked to make presentations at both the February FDA/NCI workshop (https://cms.palladianpartners.com/cms/1156354418/home.htm#) and at a Session 1 presentation in a January Immunotherapy Conference prior to Session 2, a series of presentations being moderated by Dr. James Mule’, the Chairman of the FDA CBER Cellular, Gene Therapy and Tisuue Advisory Committee, the panel, which DNDN has indicated will review Provenge in March. See: www.moffitt.org/Site.aspx?spid=621529...

    6. The accumulating weight of evidence in immunology is that in spite of the tremendous progress being made with therapeutic cancer vaccines, these therapies still need help in overcoming regulatory T cells and other immunosuppressive effects. Many in the immunology community are urging the FDA to ease the normal oncology eficacy requirements for cancer vaccines given their low side effect profile. See: www.pnas.org/cgi/content/full/103/39/...

    7. IMHO, FDA Commissioner Dr. von Eschenbach may use his speech at the February FDA/NCI workshop to reaffirm the importance of using statistically significant measures of clinical benefit, in particular, increased survival, to receive FDA approval of new therapeutic cancer vaccines, potentially citing Dr. Rosenberg’s work at the NCI in melanoma and DNDN’s Provenge’s clinical trial results to show that it can be done, even if presently FDA approved chemos/adjuvants are still required, and with several new ones rapidly progressing through clinical trials to be of future benefit. FDA acceptance of other immunology markers will await additional research and future prospective clinical trials. Most early cancer vaccines may require the use with chemos or other adjuvants to achieve statistical significance in clinical trials until the technology is further improved. All of which, IMHO, simply reaffirms that FDA approval of Provenge, version 1, will set the bar, and will only
  17. [verwijderd] 20 december 2006 22:53

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    quote:

    luckyhand schreef:

    Goede morgen,

    Ik zit al een tijdje in Dendreon (DNDN), dit aandeel kan zeker dit jaar nog minimaal verdubbelen.
    Goedkeuring product (kankervacin) zeer dichtbij.
    Doe je voor of nadeel.
    Groet,

    Lucky

    fondscode Alex: 122859
    fondscode Binck: 101321

    finance.yahoo.com/q?s=DNDN
    bedankt voor de tip "luckyhand".
    bovenstaand je eerste post van dit draadje.
    het aandeel noteerde toen 4.86 en een jaar geleden deed dendreon nog 5.25.

    maw, tot nu toe is het: doe je nadeel.

    ps: succes met gtcb, nog geen 10 euro zoals door jouw voorspeld voor dit jaar maar t scheelt niet veel.
    dwz een nul scheelt t.

    als je nog meer tips hebt hoor ik t graag.

    mvg,
  18. [verwijderd] 20 december 2006 23:02

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    [quote=luckyhand]
    Vandaag waarschijnlijk de laatste handelsdag om nog onder de 5 dollar in te stappen.
    Ik verwacht dat de koers van dit aandeel over enkele maanden verdubbeld, sterker nog 15 tot 50 dollar eind dit jaar, behoort absoluut tot de mogelijkheden.
    Doe je voor of nadeel :)
    Groet,

    Lucky

    dit is ook een mooie.
    zal wel een kwestie van geduld blijken te zijn.

    mvg
  19. [verwijderd] 20 december 2006 23:14

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    quote:

    connect schreef:

    ps: succes met gtcb, nog geen 10 euro zoals door jouw voorspeld voor dit jaar maar t scheelt niet veel.
    dwz een nul scheelt t.

    als je nog meer tips hebt hoor ik t graag.

    mvg,
    het zit je blijkbaar wel allemaal wel erg hoog,
    om steeds iemand anders de schuld te geven
    en ja hoor, want die ander heeft hieraan steeds de schuld
    makkelijk toch, om deze steeds met de vinger te wijzen
    had het positief geweest, was je er zeker nietop teruggekomen
    je wijst merendeel alleen op de nega-kant

    achteraf praat het allemaal zoveel makkelijker !!
  20. [verwijderd] 20 december 2006 23:22

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    quote:

    luckyhand schreef:

    Voor mij is het niet de vraag of we door de 5 dollar gaan, maar of we binnen 1 of 2 maanden al de 10 dollar gaan nemen.

    Wordt het niet tijd voor een nieuwe alias?
    Ik heb nog wel een aantal suggesties:
    - Platzak
    - Zweetfeet
    - Bigmouth

    Nu voor slechts 5 dollar per naam.
  21. [verwijderd] 21 december 2006 15:23

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    FWIW, the statistics for being approved in the first-cycle for applications between 2002 and 2004 are like this:

    FastTrack: 58%
    Without Fast Track: 42%
    Priority Review: 62%
    Without Priority Review: 34%
    With advisory committee: 31%
    Without advisory committee: 46%
    New MOA + Life threatening condition: 73%

    The percentages should be read as of all the applications with a given status, how many were approved in the first cycle. For example, the details of all applications with Priority Review are 62% approved in the first cycle, 36% in multi-cycle and 2% rejected.

    For a drug that saves life in a terminal condition, approval rate is highest at 73%. Of course, when it comes to a single BLA, the quality of the application is what counts.
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