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Mooi instap moment Dendreon

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  1. [verwijderd] 2 mei 2007 16:58

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    Analyst Comments Sponsored by:
    Needham Remains Positively Inclined Toward FDA CBER Approval for Dendreon (DNDN) Provenge
    05-02-2007 10:24:27 AM

    Needham issued a note on Dendreon Corp. (Nasdaq: DNDN) with about two week unitl the PDUFA on Provenge. The firm remains positively inclined toward FDA CBER approval for Provenge. The firm reiterated their Buy rating and $22 price target.

    Analyst Mark Monane and Richard Yeh said, "We had the opportunity to speak with biotech and academic sources who have been involved in regulatory affairs. As a result of these discussions, we remain positively inclined toward an approvAL letter for Provenge for the management of asymptomatic, metastatic, androgen independent prostate cancer. We believe the letter will include a Phase 4 post-marketing surveillance commitment to complete and report the data from the ongoing D9902B trial. We base our opinion on the conduct of the panel meeting, the positive vote on efficacy, the unanimous vote on safety, and the few treatment options for the number one non-skin cancer in the US today.

    They continued, "We do, however, note that there are some weaknesses in the current Provenge CBER application (such as the relatively small 127 patients in the D9901 trial, P>0.05 for primary outcome, survival not prespecified as a study outcome) as well as the ongoing large SPA-designed Phase 3 trial (giving the FDA another option for an approvABLE letter based on the set-up and execution of the ongoing D9902B trial). We are impressed with the flurry of letters on this subject from FDA advisors and concerned physicians alike, but we believe the only letter that matters at this time is the PDUFA letter from the FDA."

    The firm puts an approvAL valuation at $27 and an approvABLE valuation at $6.

    Stocks Mentioned

    Groet.

  2. [verwijderd] 3 mei 2007 11:55

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    Dendreon: The Perfect Storm is Brewing
    Thursday May 3, 5:27 am ET

    Karuna Kanagaratnam submits: The perfect storm is definitely brewing at Dendreon (NasdaqGM: DNDN). Dendreon traded at a high of $26.63 in September 2000 and reaching a low of $1.26 in July 2002.

    Today the May 30 call options (which give you the right to buy Dendreon stock at $30 until May 19, 2007) are trading between $1.40 and $1.60. Four thousand forty (4,040) contracts were traded today. Each contract represents 100 underlying shares and sold at an average of $150 each.

    That’s right; the value of those contracts was $606,000. This is where things get spicy.

    On top of what was traded yesterday, there is already an open interest of 42,150 contracts. Some of those that traded today or they may have come from those open interests or from new positions. For the purposes of illustration, I will assume that half were new positions and half were sales from the open interest (I expect the open interest to be about 44,000 contracts tomorrow).

    The 44,000 contracts at $150 of average traded price today amount to $6,600,000.

    But here is the catch. May 30 calls are not the mostly traded or with the most open interest. There are strike prices ranging from $2.50 all the way up to $50.00 representing 15 different strike prices.

    One thousand one hundred and eighteen (1,118) May 50 calls changed hands today at prices up to $25.00. That’s on top of 1,790 open contracts through Tuesday. Is someone afraid that the price might go over $50.00 by May 19th, or are they hoping it will go over $50.00?

    All in all, there are over 507,000 contracts of open interest for May, and another 32,000 plus changed hands today. Again, assuming 50% new positions, that would leave us with 533,000 contracts which represent 53,300,000 shares just for the month of May.

    On the put side (which gives you the right to sell Dendreon shares at various strike prices) we have approximately the same number of contracts. The value of all the open interest of call and put contracts in May alone amount to over four hundred million dollars ($400,000,000) at today’s trading prices.

    What makes all of this even more significant? The stock closed today at $17.17 up $1.00.

    The total market capitalization on the week of March 26th was barely four hundred million dollars ($400,000,000). As a matter of fact, on March 21st DNDN traded at a low of $3.57 making the entire value of DNDN at barely three hundred million dollars ($300,000,000.00).

    We have traded over 18,500,000 shares today bringing the total to over 740,000,000 shares in the last 23 trading days!

    Yes, a perfect storm is brewing!

    In my next article, I will explore the impact of the short interest which is approaching 50% (actually over 100% of the shares available for trading).

    Disclosure: Author is long DNDN
  3. [verwijderd] 3 mei 2007 20:42

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    May 3, 2007 2:02 PM ETDendreon Up As Provenge Ruling
    (DNDN) Stock Quote, Chart, News
    All Associated Press NewsNEW YORK (AP) - Dendreon Corp. shares climbed in heavy trading Thursday, up for a third straight day despite mixed analyst views about its prostate cancer vaccine Provenge.

    Dendreon stock soared March 30 after a Food and Drug Administration panel said clinical data show Provenge is safe and effective. Shares kept rising for the next six days, more than quadrupling in value.
    The FDA is to rule on Provenge by May 15, and Next Generation Research analyst Liisa Bayko said Thursday she is increasingly confident the agency will approve the drug. Citing discussions with pharmaceutical industry sources and the transcript of the panel that recommended approval, she upgraded Dendreon stock to "Buy" from "Neutral."

    "This is an area with a huge unmet medical need," she said.

    AG Edwards analyst Aaron Reames began covering the Seattle-based company with a "Hold" rating Wednesday, calling the stock high-risk because it is unclear if Provenge will be approved. He noted the drug did not meet its primary or secondary goals in a late-stage clinical trial, and said the FDA may want more data.

    On Monday, Cowen & Co. analyst Eric Schmidt said two physicians he spoke with expect strong demand for Provenge if it is approved, and would prescribe it because of the safety data. However, they are not convinced the drug has been proven effective, Schmidt said, and do not think a larger, ongoing trial -- with results due in a year -- will provide that proof.

    Schmidt said the two physicians hope the agency does not approve the drug. "They believe it would be a disservice to patients, physicians and payors to approve Provenge and optimistic that cooler heads will prevail at the FDA," he said.

    The stock advanced 80 cents, or 4.7 percent, to $18 Thursday. Trading was nearly double the stock's average. Dendreon shares gained $2.17, or 14.4 percent, Tuesday and Wednesday.

    © 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  8. [verwijderd] 4 mei 2007 17:18

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    Heb juist bijgekocht kijk eens wat een volume er al is.

    The FDA is to rule on Provenge by May 15, and Next Generation Research analyst Liisa Bayko said Thursday she is increasingly confident the agency will approve the drug.

    Last Change High Low Volume Prev. Close Day's Range 52 Week Range
    21.24 2.76 21.81 19.00 18,110,350 18.48 19.00 to 21.81 3.57 to 25.25
  13. [verwijderd] 4 mei 2007 18:35

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    quote:

    wishdom schreef:

    ff lezen Jip,best interessant.

    Suc6.

    Met vriendelijke groet.

    www.thestreet.com/_googlen/newsanalys...
    Na een prima onbijt en een uurtje vrij:

    In 2006, 38 drugs received advisory committee recommendation for approval. Of those 38, 37 were approved. The one exception was withdrawn by the company before the FDA could make a decision. So the chances of approval are around 37/38 or 97.37%.

    Nu: + 10% (20.33)

    Tot maandag, work to do!

    Psycho
    greetings from the windy city
  14. jip banaan! 4 mei 2007 20:58

    • jip banaan!

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    quote:

    psycho-pharma schreef:

    [quote=wishdom]
    ff lezen Jip,best interessant.

    Suc6.

    Met vriendelijke groet.

    www.thestreet.com/_googlen/newsanalys...
    [/quote]

    Na een prima onbijt en een uurtje vrij:

    In 2006, 38 drugs received advisory committee recommendation for approval. Of those 38, 37 were approved. The one exception was withdrawn by the company before the FDA could make a decision. So the chances of approval are around 37/38 or 97.37%.

    Nu: + 10% (20.33)

    Tot maandag, work to do!

    Psycho
    greetings from the windy city

    thanks wish, gelezen en begrepen.
    het blijft een gok!

    groet jip!
  15. [verwijderd] 4 mei 2007 22:18

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    quote:

    jip banaan! schreef:

    [quote=psycho-pharma]
    [quote=wishdom]
    ff lezen Jip,best interessant.

    Suc6.

    Met vriendelijke groet.

    www.thestreet.com/_googlen/newsanalys...
    [/quote]

    Na een prima onbijt en een uurtje vrij:

    In 2006, 38 drugs received advisory committee recommendation for approval. Of those 38, 37 were approved. The one exception was withdrawn by the company before the FDA could make a decision. So the chances of approval are around 37/38 or 97.37%.

    Nu: + 10% (20.33)

    Tot maandag, work to do!

    Psycho
    greetings from the windy city

    [/quote]

    thanks wish, gelezen en begrepen.
    het blijft een gok!

    groet jip!
    Nah Jip,ik denk dat je ook even moet kijken of het management niet zijn zakken vuld,en wat de ceo verdient.
    Dan pas heb je een goed beeld of je moet(bij)kopen of verkopen.

    Hahahahahahahahaahahahahahahahahahahaahahahaha.

    Groet,en een fijn weekend.
  16. [verwijderd] 4 mei 2007 22:46

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    quote:

    wishdom schreef:

    Nah Jip,ik denk dat je ook even moet kijken of het management niet zijn zakken vuld,en wat de ceo verdient.
    Dan pas heb je een goed beeld of je moet(bij)kopen of verkopen.

    Hahahahahahahahaahahahahahahahahahahaahahahaha.

    Groet,en een fijn weekend.
    ~~... of het management niet zijn zakken vulT~~
    Niet uit z'n context halen, wish.
    Toch fijn dat je erzelf mee kunt lachen.

    Ook naar u toe een zéér aangenaam weekend gewenst.
  20. [verwijderd] 6 mei 2007 16:30

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    Goedemor..middag, ik ben weer terug in de stad en niet ontevreden over het koersverloop van Denni (vrij naar Legi's INNI en ENNI).

    From investor village (gleeman) (9 Ratings) 6-May-07 04:55 am (

    Advanced Prostate Cancer) The Prostate Cancer Community Reaffirms their Support for Provenge

    The coming news...

    please visit advancedprostatecancer.net/?p=31

    Signing on to this statement are the following organizations:

    1. Us TOO International
    2. Prostate Cancer Research Institute
    3. Prostate Health Education Network
    4. Malecare
    5. National Alliance of State Prostate Cancer Coalitions
    6. Virginia Prostate Cancer Coalition
    7. Georgia Prostate Cancer Coalition
    8. Washington State Prostate Cancer Coalition
    9. Prostate Cancer Coalition of Michigan
    10. National Prostate Cancer Coalition
    11. American Prostate Cancer Initiative
    12. The Prostate Cancer Education Forum of Connecticut
    13. Maine Coalition to Fight Prostate Cancer
    14. Nevada’s Prostate Cancer Task Force
    15. Prostate Cancer Support Association of New Mexico
    16. Hawaii Prostate Cancer Coalition
    17. Texas Prostate Cancer Coalition
    18. Prostate Cancer 101 of New York
    19. New York Prostate Cancer Coalition

    Psycho
    geen jetlag
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