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Mooi instap moment Dendreon

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  2. [verwijderd] 29 maart 2007 22:27

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    The Street:

    FDA Panel Smiles on Dendreon's Provenge

    By Adam Feuerstein
    Senior Writer
    3/29/2007 4:21 PM EDT
    Click here for more stories by Adam Feuerstein

    Dendreon (DNDN - Cramer's Take - Stockpickr) wins.
    On Thursday afternoon, an advisory panel of the Food and Drug Administration voted 13-4 to support approval of Dendreon's prostate cancer vaccine, Provenge.

    The positive panel vote came after a day of testimony and presentations from the company and FDA reviewers examining the safety and efficacy of Provenge. If the FDA follows through on the panel's recommendation, Provenge will become the first vaccine, or immunotherapy, ever approved to treat cancer.

    The FDA is expected to make its final approval decision by May 15.

    Provenge works by stimulating the patient's own immune system to recognize and kill prostate cancer cells. In a phase III clinical study, patients taking Provenge lived 4.5 months longer than patients given a placebo.

    Dendreon shares were halted all day on Thursday, but closed Wednesday at $5.22.

    There are approximately 232,000 new cases of proatate cancer diagnosed each year in the U.S., making it the most diagnosed cancer in men in this country. More than 30,000 men die from the disease each year, second only to lung cancer.

  4. [verwijderd] 29 maart 2007 22:28

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    quote:

    rac69 schreef:

    dit is big news op het moment.
    Zelfs Reuters is positief:

    US panel says Dendreon cancer therapy effective
    4:19 p.m. 03/29/2007 Provided by
    GAITHERSBURG, Md., March 29 (Reuters) - Dendreon Corp. (DNDN) provided substantial evidence of effectiveness for its experimental prostate cancer treatment Provenge, U.S. advisers said on Thursday in a 13-4 vote.
    Earlier, the Food and Drug Administration panel had said studies showed Provenge was reasonably safe.
  6. [verwijderd] 29 maart 2007 22:35

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    quote:

    rac69 schreef:

    op cnbc zeggen ze dat de koers gaat exploderen morgen.
    Ik heb CNBC op de achtergrond aanstaan (geluk voor mijn huwelijk is wel, dat we 3 TV's in huis hebben), maar ik heb het nog niet gehoord, maar dat ligt waarschijnlijk aan de wall of sound, die die yanks de kamer ingooien. In die brij is geen apart woord als Dendreon te horen.

    Ik denk wel, dat ik moeilijk in slaap kom.

    P.
    jaha, ik kom zo!!!!!!
  8. [verwijderd] 29 maart 2007 23:08

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    I'm off to bed!!

    CNBC.com

    Dendreon's Prostate Cancer Drug Effective, FDA Panel Says
    Topics:FDA | Pharmaceuticals
    Companies:Dendreon CorpBy CNBC.com | 29 Mar 2007 | 04:56 PMFont size: Federal health advisers have endorsed an experimental vaccine from Dendreon to treat advanced prostate cancer as safe and apparently effective.

    The Food and Drug Administration advisers voted unanimously Thursday to say Provenge is safe. They then voted 13-4 to say there is substantial evidence that it works in treating advanced prostate cancer that no longer responds to hormone treatment.

    Dendreon shares Dendreon Corp (DNDN)
    were halted after Wednesday's close and did not resume trading after the FDA news came out on Thursday just before the market close.

    Dendreon shares rose sharply on Wednesday after CNBC reported the planned FDA hearing. About one third of Dendreon shares are sold short.

    Dendreon sought a positive recommendation for FDA approval of what would be the first-ever therapeutic cancer vaccine, reported CNBC pharmaceuticals reporter Mike Huckman. The drug, Provenge, has failed to meet some testing endpoints, but also shows signs of conferring survival benefits. Another key hurdle was cleared: the panel voted unanimously -- 17-0 -- that Provenge is "reasonably safe," Huckman said.

    Dendreon Chief Executive Officer Dr. Mitchell Gold will be interviewed live Friday, March 30 at 6:30 am New York time on CNBC's "Squawk Box."

    The FDA isn't required to follow the advice of its advisory committees, but it usually does. A final FDA decision on whether to approve Provenge, also called sipuleucel-T, is expected May 15.

    Neither of two studies Dendreon submitted to the FDA in support of its application achieved their primary goal in showing Provenge delayed the progress of the disease, according to the agency.

    However, the results of the first study suggested the vaccine could extend the lives of patients by 4.5 months compared to those given only dummy treatment.

    The only other prostate cancer drug shown to prolong the lives of patients is Taxotere, also called docetaxel.

    If ultimately approved, Provenge would become the first of a new class of therapies designed to stimulate a patient's own immune system against cancer, according to Dendreon.

    Prostate cancer is the most common cancer in American men, other than skin cancer. The American Cancer Society estimates there will be about 220,000 new cases this year, and about 27,000 deaths.

    The vaccine combines a protein found in most prostate cancers with a substance that helps specialized immune system cells recognize cancer as a threat, just as they recognize and confront germs that enter the body.

    The treatment is customized for each patient. Doctors collect these cells from a patient's blood, mix them with the vaccine, and then give the concoction back to the patient.

    Dendreon also is testing Provenge for less serious cases of prostate cancer.

    Psycho
    "Dendreon Chief Executive Officer Dr. Mitchell Gold will be interviewed live Friday, March 30 at 6:30 am New York time on CNBC's "Squawk Box."

  9. [verwijderd] 29 maart 2007 23:36

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    WSJ-online
    FREE PREVIEW
    Prostate-Cancer Drug Wins Panel's Backing
    By Jennifer Corbett Dooren
    Word Count: 305 | Companies Featured in This Article: Dendreon
    WASHINGTON -- A Food and Drug Administration panel of outside medical experts Thursday backed a proposed prostate-cancer treatment designed to stimulate a person's immune system to fight the cancer despite concerns the drug might not be that effective.

    The panel unanimously said the proposed treatment, Provenge by Dendreon Corp., Seattle, was safe. It also said the FDA should consider approving the drug ...
  10. [verwijderd] 30 maart 2007 00:08

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    quote:

    dollie schreef:

    WSJ-online
    FREE PREVIEW
    Prostate-Cancer Drug Wins Panel's Backing
    By Jennifer Corbett Dooren
    Word Count: 305 | Companies Featured in This Article: Dendreon
    WASHINGTON -- A Food and Drug Administration panel of outside medical experts Thursday backed a proposed prostate-cancer treatment designed to stimulate a person's immune system to fight the cancer despite concerns the drug might not be that effective.

    The panel unanimously said the proposed treatment, Provenge by Dendreon Corp., Seattle, was safe. It also said the FDA should consider approving the drug ...

    Beste P,C
    net terug vd dienst en wat zien ik....eindelijk eens dubbeltje goede kant opgevallen, jammer dat ik hier niet inzat met 100k aandelen helaas maar 15k.... gekocht ben benieuwd wat ie gaat doen..... stijgen is zeker direkt naar de 15???
    in ieder geval van harte !!!
    gr leg
  12. [verwijderd] 30 maart 2007 00:19

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    Dendreon Announces FDA Advisory Committee Reviewed Provenge® for Hormone Refractory Prostate Cancer
    --Committee Recognizes Substantial Evidence of Efficacy and Safety in this Patient Population--

    --New time for conference call at 6:30 PM ET--
    SEATTLE, WA, March 29, 2007 – Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration's (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of PROVENGE (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer. If approved for marketing by the FDA, PROVENGE would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. The FDA will now review the advisory committee's recommendations. The Company anticipates a decision on PROVENGE by May 15, 2007.
    The Advisory Committee was asked if the submitted data established that sipuleucel-T (APC-8015) is reasonably safe and whether there is substantial evidence that the product is efficacious.
    The Advisory Committee voted 17 to 0 in favor of the safety of PROVENGE in response to the question and 13 to 4 in favor of the efficacy question.
    "Today marks an important milestone for men with advanced prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "If approved, PROVENGE could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options. We look forward to working closely with the FDA."
    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 218,890 new cases of prostate cancer diagnosed each year. More than 27,000 men die each year of the disease.
    Conference Call Information
    Time: 6:30 pm ET / 5:30 pm CT / 4:30 pm MT / 3:30 pm PT
    Date: March 29, 2007
    Dial-in: 1-800-289-0572 (domestic) or +1-913-981-5543 (international)
    Webcast: www.dendreon.com (homepage and investor relations section)
    A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 or +1-719-457-0820 for international callers; the conference ID number is 4486335. The replay will be available from 9:30 pm ET on Thursday, March 29th until 11:59 pm ET on Monday, April 2nd. In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.
    About PROVENGE
    PROVENGE is an investigational product that may represent the first in a new class of active cellular immunotherapies 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.
    investor.dendreon.com/ReleaseDetail.c...

    Via:
    crucell.yourbb.nl/viewtopic.php?p=170...
  14. [verwijderd] 30 maart 2007 01:06

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    Zoals ik al verwachtte kon ik niet slapen.
    Dan maar naar de webcast geluisterd.

    Ze zijn er allemaal: CEO,CFO,CSO

    Gold (CEO)
    Werkt komende tijd stevig samen met de FDA.

    Q&A
    (Allemaal grote jongens zijn aan de lijn.)

    Commercial plans: komt er EU aanvraag?
    Eerst FDA

    Hoe loopt de grote studie?
    400 patienten al, dus gaat goed

    Market potential?
    98.000 + 50.000
    EU idem
    Azie onbekend

    Timeline wanneer de fabriek OK is.
    Pre-approval komt eraan. 2 maanden

    125 nieuwe personeelsleden voor marketing (na 15 mei, als de FDA officieel groen licht geeft)

    Raising money
    Nog geen thema, komt vast wel geld aan na mei 15. Geen opmerking over een partner.

    Needham: fantastische dag voor patienten

    Ze bespreken de uitslag van vandaag met de FDA naar een uitspraak op 15 mei. De FDA beslist dus in overleg met hen.

    Bank of America:
    Ze gaan niet in op het gedrag van de commissie-leden.

    UBS: hoeveel mensen zitten nu in het onderzoek?
    400, niet 300 zoals UBS denkt.

    Lazard:
    Wijkt de FDA af van zijn eigen gedragslijn door een extra instructie van de commissie?
    Nee, het zijn gewoon de nieuwe richtlijnen.

    (trouwens, alle bellers kennen de directie persoonlijk)

    DNDN blijft duurzaam openheid geven over de discussie de komende weken met de FDA.Dus voor 15 mei kan er al duidelijkheid zijn over de definitieve positie van de FDA.

    Closing remarks:
    a historic day!! Voor de patienten, voor het bedrijf en voor de nieuwe techniek.

    Iedereen bedankt, ook de aandeelhouders, voor hun steun.

    Geen dank,
    Psycho

  15. jip banaan! 30 maart 2007 01:41

    • jip banaan!

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    toch bedankt psycho! voor je bijdrage, neem nog maar een wiskey!
    hier.. banaantje en ga nou maar lekker slapen, morgen feest! Oesters eten dus!

    greot jip!
  16. [verwijderd] 30 maart 2007 07:50

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    Re: JMP raised to $20 Stanford Fin still fighting panel decision
    PT=price target (1yr)

    JMP excerpt...3/30

    INVESTMENT HIGHLIGHTS
    · CBER panel votes in favor of Dendreon’s Provenge on safety and efficacy; reiterate Strong
    Buy and increasing price target from $12 to $20. Yesterday, the Cellular, Tissue, and Gene
    Therapies Advisory Committee organized by Center for Biologics Evaluation and Research (CBER)
    strongly voted in favor for the safety and efficacy data in Provenge’s BLA for the treatment of latestage
    prostate cancer. The panel voted unanimously that the data showed Provenge to be a safe
    drug. Additionally, the panel voted 13 to 4 in favor of the data establishing substantial evidence of
    efficacy. However, all of the panelists commented that results from the ongoing IMPACT trial would
    be necessary to confirm the drug’s survival benefit. Based on the favorable vote and panelist
    remarks, we continue to believe that the FDA will grant Provenge an approvable letter and will
    require data from the interim analysis from the ongoing SPA-backed IMPACT study which we
    expect in mid-08. However, given the company’s stated intent to complete this study and its
    current late stage of patient enrollment, we now assign a higher probability to an out-right approval
    (50%, previously ~25%) and assign the remaining 50% probability to an approvable letter
    (previously estimated ~70%). In addition, we believe the panel vote and commentary to clearly
    signal robust physician interest in this novel treatment. Therefore, we now anticipate faster and
    perhaps broader adoption than previously modeled, driving greater potential revenue ($1 billion) at
    peak. We are fine-tuning our revenue assumptions as a result, ramping our estimates in FY08-
    FY10, while also sliding our FY07 estimates into FY08. Our FY07 net loss per share increases from
    $0.49 to $1.15 per share, but our out-year EPS increases significantly (see details in note) with our
    valuation year (FY10) now being $1.27 (old $0.84). Using our previously published valuation
    methodology for DNDN shares (25x 2010 EPS discounted at 25% annually), we are increasing our
    12-month price target from $12 to $20.
    · Expect pre-specified interim analysis from IMPACT by mid-08. The IMPACT trial currently has
    ~400 patients enrolled, and accrual is targeted at 500 patients (expected by mid-07). While the
    company has yet to disclose the details of the interim analysis, we expect it will be triggered by
    about one-third (120 deaths) of the events of the final analysis (360 deaths). Based on the final
    data expected in 2010, survival assumptions in metastatic, hormone-refractory prostate cancer
    (HRPC) patients, and a slow enrollment in the first two years of the trial,
    we expect the interim
    analysis to occur about a year from now, as previously published.

    · Panel enthusiasm signals greater market potential. In the US, there are about 100,000
    metastatic HRPC patients with about 50,000 being asymptomatic. We had previously based our
    revenue assumptions on this population of patients. However, after the high level of patient
    advocacy involvement in the advisory committee and strong support from the panel members, we
    believe once the drug is approved, penetration into this population could be achieved more rapidly
    than we anticipated. In addition, we anticipate positive experience with Provenge in later stage
    patients could translate into off-label use in earlier stages of disease, which represents a larger
    market opportunity with about 200,000 newly diagnosed prostate cancer patients per year in the
    US. Based on these assumptions, we believe the commercial opportunity of Provenge could be on
    the order of $1 billion by 2012 compared to our previous estimate of $500 million. Specifically, we
    now assume an annual treatment cost of $30,000, with a 45% penetration of the pool of 50,000
    asymptomatic patients, with use of this expected label to present upside potential.
    · Increasing revenue estimates and raising price target from $12 to $20. Based on the high
    visibility we believe Provenge has attained in the patient advocacy and urology communities, we
    anticipate robust adoption in the HRPC population once the drug comes to market in 2H08. As
    such, we are sliding our previous FY07 revenues into FY08 and increasing our penetration rates for
    FY09 and FY10. Our revenues for FY08-FY10 increase from $225 million, $429 million, and $510
    million to $301 million, $510 million, and $690 million, respectively. Our EPS estimates from FY08-
    FY10 increase from $0.31, $0.69, and $0.84 to $0.56, $0.90, and $1.27, respectively. Employing
    our previously published valuation methodology for DNDN shares (25x 2010 EPS discounted at
    25% each year) and applying it to our new FY10 EPS of $1.27, we derive our new 12-month price
    target of $20.


  19. [verwijderd] 30 maart 2007 09:31

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    Ja Psych, ik kon ook niet slapen, tenslotte zijn we al maanden op dit aandeel gefocussed geweest.
    Hoe verder, ik heb een stukje gecopieerd van een zeer doorgewinterde trader, die ook al lang totaal gegrepen was door DNDN en de nog lang niet afgelopen oorlog met de shorters:

    Re: TRDRPRZ what is happening on the floor? Any initial supply/demand imbalance to witness?

    It is after hours with a news conference on the way, so there will not be any evening trades. Flat out guess, open at $10, range $9 to $18, close at $15. News gets out HUGE over the weekend, likely trade as high as $25 monday.

    All depends on what our shorts do. If they try to cap, it will stay down. Predictions above assume they do nothing. If they truly try to cover, all bets are off. There are not enough shares for that. The exit door is small and closing fast. But I don't think they will cover tomorrow, if they do. Quite frankly, they can't, not without pushing the price north of $50, which means they are bankrupt, so they will let it ride, then crack it hard when they sense weakness, and slowly cover in the coming weeks.

    They will have info out tomorrow. Will play up the wording chance, FDA still might not approve, study will be required, drug won't sell because of questions, and finally the big shelf waiting to be sold.
    quote""
    Don't expect to much from DNDN tonight on the press conference. The FDA decision is not in hand yet. They will stick to financials, thank the panel, etc., but in no way upset anyone at the FDA. Unless of course they have a ROW deal in their pocket.....

    Going to be fun tomorrow. Gonna' be fun to watch these rats scramble. Make sure to stomp on as many as possible; I will.

    Email this page to a friend
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