BioPharma Terug naar discussie overzicht

Mooi instap moment Dendreon

1. [verwijderd] 19 oktober 2006 21:58

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   Het lijkt erop, dat "ze" hem day-high willen laten sluiten. Als dat ze lukt, dan redt morgen zelfs de nieuwe TU-TNO-paraplu het niet tegen de storm, die dan opsteekt.
   
   P.
2. [verwijderd] 19 oktober 2006 22:02

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   Op 1 cent na DH: 5.29
   
   ++ 37 cents
   
   ++ 7,52%
   
   1,5 milj. aandelen.
   
   P.
3. [verwijderd] 19 oktober 2006 22:06

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   leuk idd
   ;o)
   
   psycho: jij nog volledig in insm?
   ik wel, ga hem volledig uitzitten en alles behalve injunctie zal goed zijn daar
   minder risico dan dndn vooralsnog
4. [verwijderd] 19 oktober 2006 22:14

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   quote:

   crackedtooth schreef:

   leuk idd
   ;o)
   
   psycho: jij nog volledig in insm?
   ik wel, ga hem volledig uitzitten en alles behalve injunctie zal goed zijn daar
   minder risico dan dndn vooralsnog
   

   DNDN 5K
   INSM 180K
   150 prive
   30 BV
   Verkoop beide pas boven de $22,-
   
   P.
5. [verwijderd] 19 oktober 2006 22:21

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   quote:

   psycho-pharma schreef:

   [quote=crackedtooth]
   leuk idd
   ;o)
   
   psycho: jij nog volledig in insm?
   ik wel, ga hem volledig uitzitten en alles behalve injunctie zal goed zijn daar
   minder risico dan dndn vooralsnog
   [/quote]
   
   DNDN 5K
   INSM 180K
   150 prive
   30 BV
   Verkoop beide pas boven de $22,-
   
   P.
   

   effe checken, vind je oprecht in je postings, beetje teleurgesteld in sommige anderen
   ;o)
   zelf ook nog long en zeker nog lange tijd
   zzp
   dus alles prive
   
6. [verwijderd] 20 oktober 2006 13:08

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   technische breakout .. en nieuwe DATA pr
   
   Dendreon Announces New Data Analyses Presented at Prostate Cancer Foundation Scientific Retreat
   Friday October 20, 7:00 am ET
   PROVENGE Significantly Extends Prostate Cancer Specific Survival in Advanced Prostate Cancer
   
   SEATTLE, Oct. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco presented new exploratory analyses of the Phase 3 Study (D9901) that further support the results observed with the Company's investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with advanced androgen- independent (hormone refractory) prostate cancer.
   ADVERTISEMENT
   
   
   These data were presented at the Prostate Cancer Foundation's 13th Annual Scientific Retreat held Oct. 19-21, 2006 in Scottsdale, Arizona. The Company plans to complete the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) prior to the end of this year to seek approval to market PROVENGE.
   
   The analyses presented by Dr. Small showed:
   
   -- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and
   
   -- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).
   
   A link to Dr. Small's presentation will be available via Dendreon's web site at www.dendreon.com.
   
   "These and other analyses we have performed further support our BLA filing, which we intend to complete this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We remain focused on the goal of making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer who currently have few appealing treatment options available to them."
   
   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.
   
   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 early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
   
   Treatment with PROVENGE was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with PROVENGE were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.
   
   Dendreon has submitted one of two portions of a rolling submission of a BLA with the FDA for PROVENGE as an active cellular immunotherapy treatment for asymptomatic men with metastatic, androgen-independent prostate cancer. The Company expects to submit the chemistry, manufacturing and controls (CMC) section prior to the end of 2006. If approved, PROVENGE would become the first commercially available active cellular immunotherapy for advanced hormone- refractory prostate cancer.
   
   -------------------
   
   leuke insteek
   
   -- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and
   
   -- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).
   
   
7. [verwijderd] 20 oktober 2006 13:47

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   De slides van de presentatie zeggen nog meer
   
   investor.dendreon.com/downloads/22568...
   
   vooral slide 14 en 15
8. [verwijderd] 20 oktober 2006 15:06

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   Line-up: 5.50 - 5.52
9. [verwijderd] 20 oktober 2006 15:09

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   Crack, kan jij de voorbeurshandel ergens zien?
   Op Tradebox geeft hij niets aan.
   
   Psycho
   Ik ben een favoriet van slide 9: 11% overlevenden na 3 jaar met placebo (= zonder bijzondere behandelingen behalve de gebruikelijke) tegenover 34% overlevenden na 3 jaar door Sipuleucel-T van Dendron.
   Deze cijfers zijn echt "killing".
10. [verwijderd] 20 oktober 2006 15:11

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    quote:

    psycho-pharma schreef:

    Crack, kan jij de voorbeurshandel ergens zien?
    Op Tradebox geeft hij niets aan.
    
    Psycho
    

    Er zijn 103.000 aandelen verhandeld tot nu toe, rt 5.70.
11. [verwijderd] 20 oktober 2006 15:14

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    quote:

    Smike schreef:

    [quote=psycho-pharma]
    Crack, kan jij de voorbeurshandel ergens zien?
    Op Tradebox geeft hij niets aan.
    
    Psycho
    [/quote]
    
    Er zijn 103.000 aandelen verhandeld tot nu toe, rt 5.70.
    

    Dank Smike.
    = dus bijna al 10% van de omzet van gisteren
12. [verwijderd] 20 oktober 2006 15:33

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    100.000 stuks per minuut.
    ++ 8%
13. [verwijderd] 20 oktober 2006 15:35

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    Shorters dumpen even voor wat rust met 192.000 stukken: gap gesloten.
    ++ 2%
    
    P.
    een waar slagveld
14. [verwijderd] 20 oktober 2006 20:03

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    quote:

    psycho-pharma schreef:

    Shorters dumpen even voor wat rust met 192.000 stukken: gap gesloten.
    ++ 2%
    
    P.
    een waar slagveld
    

    Inderdaad!! Ik ben een paar uurtjes weg en de boefjes duwen hem naar -- 5%.
    Lijkt op een professionele pump 'n dump.
    We kijken het aan, er staan nog aardig wat short.
    
    P.
15. [verwijderd] 20 oktober 2006 20:05

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    eerder 13 miljoen shorts, ga er maar vanuit vandaag flink stuk bijgekomen
    houd ze rustig vast
    heeft weer aandacht op dndn gevestigd en data extra is zeer! positief
16. [verwijderd] 27 oktober 2006 16:20

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    Dendreon Presents New Data Correlating Potency of PROVENGE to Survival in Phase 3 Studies
    Friday October 27, 9:00 am ET
    
    SEATTLE and LOS ANGELES, Oct. 27 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today 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.
    CD54 upregulation is measured on antigen presenting cells (APCs) as part of the PROVENGE product release testing prior to administration to patients. The abstract entitled "CD54 Expression in Sipuleucel-T Correlates with Activation of APCs and Clinical Outcome" describes the characterization of PROVENGE and the development of CD54 as a surrogate measure of product potency. The poster was presented today at the International Society for Biological Therapy of Cancer (iSBTc) 21st Annual Meeting in Los Angeles.
    
    "CD54 cell count and CD54 upregulation are important biologically-relevant measures used to assess the potency of PROVENGE prior to patient administration," said David Urdal, Ph.D., chief scientific officer of Dendreon Corporation. "The demonstration that there is a correlation between cumulative CD54 upregulation and clinical outcome suggests that our potency assay for PROVENGE measures an important and meaningful attribute of this product."
    
    Cumulative CD54 upregulation was evaluated in PROVENGE-treated patients from the Phase 3 Studies D9901 and D9902A. Analyzing cumulative CD54 upregulation as a continuous variable yielded a significant correlation with survival (p-value = 0.011).
    
    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.
    
    biz.yahoo.com/prnews/061027/sff009.ht...
17. [verwijderd] 31 oktober 2006 16:56

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    zo...spike naar 5.86 op dat nieuws diezelfde dag vakkundig omlaag gestuurd naar 5$ op 3,8mln volume..
    
    vorige week vakkundig margin selling harken door onder de 5$ te houden..
    
    en nu weer netjes richting de 5$..al erover geweest
    zeer binnenkort weer 5$+
    
    vorige week rond 4,80 nog wat bijgekocht
18. [verwijderd] 2 november 2006 18:52

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    DENDREON (Nasdaq: DNDN) INFORMATION SHEET
    It is our aim to keep this document honest and accurate. Suggestions for changes/additions/deletions should be posted on (http://www1.investorvillage.com/smbd.asp?mb=971&clear=1&pt=m) in reply to this message which is posted regularly on that board. And while you're at it, click on some ads to help out InvestorVillage.
    
    PREFACE
    This document was put together by a group of Dendreon investors who believe the company will successfully obtain FDA approval for Provenge, Dendreon’s prostate cancer vaccine, in the months ahead. This document should not be considered as investment advice and each person should do their own research.
    
    BACKGROUND
    Dendreon (Nasdaq: DNDN), was founded in 1992, after years of development and three successful trials, Seattle based Dendreon Corporation (Nasdaq: DNDN) is about to complete the filing of its Biologics License Application with the FDA within 2 months. The following are some facts, expert-, and non-expert- opinions on Dendreon and its lead drug, Provenge, and why many investors which include many medical doctors think DNDN is a good investment and undervalued at the current price.
    
    UNMET MEDICAL NEED = STRONG MARKET DEMAND
    • First active immunotherapy to market for patients with late stage prostate cancer and possibly earlier stage prostate cancer as well.
    • 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.
    • Only viable alternative to chemotherapy for late stage prostate cancer patients
    • 50% of patients choose not to do chemotherapy due to adverse side effects (quality of life issue).
    • prostate cancer is the third most common cancer in men, globally with half a million new cases each year, almost 10% of all cancers in men.
    • Prostate cancer is the most common non-skin cancer in America.
    • One in six American men will be diagnosed with prostate cancer.
    • A man is 35% more likely to develop prostate cancer than a woman is to develop breast cancer.
    • In 2006, more than 234,000 American men will be diagnosed with prostate cancer. That’s one new case every 2.25 minutes.
    • In 2006, more than 27,000 American men will die from prostate cancer. That’s one death every 19 minutes.
    • Approximately 2 million American men currently have prostate cancer.
    • A non-smoking man is more likely to develop prostate cancer than he is to develop lung/bronchus, colon, rectal, bladder, melanoma, lymphoma and kidney cancer combined.
    
    FDA APPROVAL
    • FDA review for approval within months
    • FDA granted the company Fast Track status and waived the approx. $750K evaluation fee that they charge each company submitting an application for drug approval. This sends me a strong message that the FDA is eager to have a look at Provenge. I guesstimate that the odds of outright approval are at least 90%, maybe approval but complete a Phase IV test 6%, approvable letter 4%, outright rejection 0%.
    • Survival has been accepted by FDA as the primary endpoint for filing of the BLA. Dendreon’s 12.3 million short gang are hoping for this not to be the case, but it is the case.
    • We're showing a strong survival benefit with a favorable safety profile.
    • FDA has approved drugs with smaller trial sizes in cases of unmet medical needs (is the case with late stage prostate cancer).
    • Regarding the chances of approval of Provenge and his experience at Immunex, Dr. Urdal said while there are no sure things as far as FDA approval goes he was very confident about Provenge chances--and that the share price action of Dendreon reminded him very much of his early days at Immunex. For those with short memories Amgen ultimately paid 16.8 Billion for Immunex to get the 750 Million a year from their Enbrel drug.
    • At its pre-BLA meeting in 9/05 DNDN was told to expect an FDA Advisory Committee meeting or a hybrid Advisory Committee for Provenge. We expect that they will vote overwhelmingly to recommend FDA Regular Approval of Provenge. That should have almost as much impact on Wall Street as the FDA approval, which should come soon thereafter.
    
    STRONG FINANCES
    [as of October 2006]
    • Very clean balance sheet. $93 Million cash as of last report. They should have enough cash to see them through FDA approval.
    • 40% of the shares are owned by institutions.
    • Retail investors including many MD’s, PHD’s, JD’s, MBA’s, etc. own several million shares of the stock.
    
    LARGE SHORT POSITION = SHORT SQUEEZE
    • 17.4% of float (12.32 Million shares) is short (potential for a big short squeeze).
    • Shorts are hoping for a low-ball secondary financing but the company has indicated that that will NOT happen and that it has several options ahead of it should it need to raise additional cash, and the more progress it makes the stronger its leverage gets.
    • We are NOT going to go into the night before the FDA decision with 12m shares short. Nowhere near that many.
    
    (NO) COMPETITON
    • Has a lead of at least a few years over its nearest competition.
    • Provenge has virtually no side effects (just minor chill and fever)
    
    MANUFACTURING
    • World-class manufacturing facility in NJ is complete for FDA pre-inspection (12 work stations)that is required for completion of the BLA. It can be expanded to 100 work stations to handle a $1 Billion sales potential.
    
    TARGET MARKET / PIPELINE
    • Muti-Billion dollar revenue potential
    • Study soon to be released could show Provenge’s effectiveness on early-stage PC patients and open up another multi-billior dollar market for it.
    • Strong pipeline of other products based on patented technology. Dendreon has temporarily cut back on reseach and other clinical trials (Neuvenge) to preserve cash to focus on Provenge entirely. Staff have been also been redeployed temporarily to focus on Provenge.
    • Dendreon discovered the trp-p8 gene and holds a patent from the U.S. Patent and Trademark Office covering it.
    
    PARTNERSHIP / INTELLECTUAL PROPERTY
    • Ex-US Partnership: But it is no great stretch to project international Provenge revenue of several billions. Both Gilead and Amgen pay 4 times estimated revenue for acquisitions of Myogen and Abgenix respectively. These acquisitions were cash payments and assumed all responsibilities for manufacturing, international regulatory filings, marketing, and continued clinical research for the products.
    • We own 100% of the worldwide rights to this program and we can move it both into earlier and later stages of disease.
    • Glaxo owns the ex-U.S. rights to Myogens drug and Gilead is only getting the U.S. rights? a cash tender offer all shorts will be closed out at $52.50 for Myogen? Shorts just lost $80 million in MYOG. All shorts must be covered when the deal closes. ALL.
    • Today’s $5 stock could be $50 within a year easily.
    
    THE TECHNOLOGY WORKS
    • The shorts’ argument that the data is not adequate doesn’t hold water any more:
    • Analysis: (1) Chemotherapy did not play a role in the overall (4 mo.) survival benefit; it was entirely due to Provenge. (2) When eliminating those who died from causes other than Prostate cancer (e.g. heart failure, etc.) from statistical analysis, patients who received Provenge survived almost a full year longer (23.5 t
19. [verwijderd] 3 november 2006 23:30

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    heel de dag geblokt rond 4,83-4,85
    laatste half uur met volume doorbroken
    
    volgende week de CC
    
    vorige cc werd de klinische BLA filing bekendgemaakt
    nu misschien de final CMC part ?(productiedeel)
    
    in ieder geval lijken de shorts de controle aan het verliezen te zijn
    
    binnenkort 5$+ en niet meer omkijken
20. [verwijderd] 5 november 2006 12:48

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    quote:

    crackedtooth schreef:

    heel de dag geblokt rond 4,83-4,85
    laatste half uur met volume doorbroken
    
    volgende week de CC
    
    vorige cc werd de klinische BLA filing bekendgemaakt
    nu misschien de final CMC part ?(productiedeel)
    
    in ieder geval lijken de shorts de controle aan het verliezen te zijn
    
    binnenkort 5$+ en niet meer omkijken
    

    Beste Crack,
    heb net een volledig overzicht gelezen op IV over DNDN; denk eraan volgende wk in te stappen; nu lijkt inderdaad de tijd rijp om ook hier in te stappen....
    gr leg