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Mooi instap moment Dendreon

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  1. [verwijderd] 6 oktober 2008 17:09
    Oct.06
    10:56 AM ET
    Biotech Bonanza For ImClone & Dendreon

    Okay, what were the chances that ImClone would get bought and Dendreon would come out with its interim test results on the same morning? Slim to none, I'd say. But that's exactly what the news gods had in store for two of the hottest names in biotech.

    In what became a poorly kept secret, Eli Lilly announced that it is going to pay 70 bucks a share for IMCL [IMCL 67.12 2.16 (+3.33%) ] in all cash money. LLY [LLY 39.27 -2.04 (-4.94%) ] CEO John Lechleiter did a "First on CNBC" interview on "Squawk Box" this morning. You can watch it here. Meantime, IMCL Chairman Carl Icahn took a told-you-so victory lap in this press release. But Miller Tabak healthcare analyst Les Funtleyder tells clients in a research note this morning that he's not sure the fight over ImClone is finished yet. "Until we get clarity on who wins IMCL and at what price it is difficult to quantify valuation," he writes.

    About an hour-and-a-half later Dendreon [DNDN 6.66 1.46 (+28.08%) ] put out the long-awaited press release with the interim results of the key study of its prostate cancer drug Provenge. The company essentially says the trend towards extending the lives of men with the disease looks promising, but at the midpoint it hasn't quite yet met the pre-specified (by the FDA) threshold for potential approval.

    So, patients and investors will now have to wait until the middle of next year for the final test results. I wonder if they might be available in time for the prestigious American Society of Clinical Oncology meeting which takes place the end of May. Not surprisingly, DNDN shares were halted for trading this morning. When they reopened they hit a new low and a new high. How's that for volatility?

    o Dendreon Stock: Who Owns It

    David Miller who writes the investment newsletter Biotech Stock Research and who's been following this story for years says the data might have convinced naysayers that Provenge might actually work. Remember, there's also a huge short interest in DNDN, so that could be fueling the move up as well. If the results had been more positive Miller predicted the stock would have surged again to $17-$22. He's a believer in Provenge, but in a recent interview he cautioned investors about Dendreon, the stock. "This is not a stock, as is no biotech stock, but particularly Dendreon, that you should have a significant portion of your retirement savings invested in. It's just too darn volatile." Apparently a couple of people on his staff, though, have a stomach for it and are owners of DNDN shares.

    o
    Eli Lilly Agrees to Buy ImClone for Over $6B
    o
    Dendreon, ImClone & Pfizer: Your Emails

    Lilly and Dendreon held their conference calls at the same time. I chose to listen to DNDN's call. CEO Dr. Mitchell Gold repeatedly said, "We're encouraged by the results we've seen, so far, and the final analysis, by design, has a higher probability of success." The Dendreon saga continues. The ImClone drama may have finally come to an end.
  2. [verwijderd] 6 oktober 2008 18:07
    quote:

    psycho-pharma schreef:

    ++71%

    Ik had onze dorps-autist wel verwacht bij dit buitenkansje..........

    P.
    Hopelijk hier toch de beloning voor allen die hier al long in zitten.En ik had hier eerlijk gezegd meer reactie op verwacht.De meesten hebben misschien al vergeten hoe volatiel dit aandeel hier wel is.Zie vorig jaar.Laat staan bij eventuele goedkeuring in 2009.

    Succes nog voor allen die ze nog hebben zou,

    8.03 Up 2.83 (54.42%)
  3. [verwijderd] 6 oktober 2008 18:16
    quote:

    skippy44 schreef:

    [quote=(( buy ))]
    Gaat enorm tekeer hier wat een omzet.
    [/quote]

    Sorry, maar hier bent u al 2 uur te laat.3
    Ja, onze dorpsgek is wat laat deze keer.
    Soms gaat de dagbehandeling wat te lang door.

    P.
  4. [verwijderd] 7 oktober 2008 02:07

    2nd UPDATE: Dendreon Provenge Data Sets Table For Final Info

    Interim analysis from a key study on Dendreon Corp.'s (DNDN) prostate cancer-treatment Provenge did not show enough to spark an amended U.S. application for the drug, but the company indicated data thus far may bode well for the future.

    The early data showed a 20% death-risk reduction for patients on the drug, compared with those on a placebo, Dendreon said. Dendreon hopes a delayed treatment effect, seen before with this type of drug, will yield improved results down the road, although analysts questioned whether that will happen.

    The Seattle company's shares, which have been very volatile for the last year and a half following the U.S. Food and Drug Administration's request for more Provenge data, recently rose $1.85, or 35.6% to $7.05 on volume of 30 million compared with average daily volume of 1.5 million.

    Monday's upswing may have been fueled by investors covering positions after betting that shares of Dendreon would decline. Dendreon's short interest, or percentage of shares betting the stock price goes lower, represents more than a third of the biotechnology company's outstanding shares, suggesting widespread expectations that Provenge could flop.

    Dendreon's drug, a so-called immunotherapy, is made from patients' own cells and is used in cases where the disease is advancing despite prior medical intervention. The late-stage "impact" trial studies the effect of Provenge in 512 men who were divided between taking the drug and taking a placebo.

    The trial's main goal is to study overall survival, and it is designed to stop once 304 patients have died - Dendreon expects to reach this point in the middle of 2009.

    At an interim follow-up point, after about two years of treatment, the data showed the 20% reduction in risk of death for patients on Provenge. The company also said that the independent committee that reported this result did not observe any safety concerns and recommended the study continue to its final analysis.

    Dendreon, which is still blinded to the study data, was unable to say whether the results thus far rise to the level of showing a statistically significant benefit for treated patients, although it did say this result is not enough to spark an amended FDA filing.

    An FDA panel recommended approval for the drug in March 2007, but the agency itself declined approval two months later because it wanted more information. That decision cast a bright spotlight on the current trial, which was already ongoing at that point.

    Mitchell H. Gold, Dendreon's president and chief executive, noted that the results seen thus far are consistent with those seen at about two years in integrated analysis from previous late-stage studies on Provenge. Those studies showed a delayed treatment effect, suggesting this study could trend in that direction, too.

    "The final analysis by design has a higher probability of success," Gold said during a conference call with analysts Monday.

    The company said that if the study demonstrates a 22% reduction in the risk of death, after 304 events, the study will likely meet its main goal.

    Banc of America analyst William Ho said, however, that what has happened in the study thus far does not necessarily point to a favorable future outcome in which the study closes the remaining gap to show a statistically significant benefit.

    "While this remains possible, we note that our experience suggests that trial differences can always confound the final results," he wrote in research note.

    "Considering the totality of the data available, we are skeptical of a positive outcome of the final analysis of the IMPACT trial," Ho added.

    Brean Murray analyst Jonathan Aschoff also raised some questions about the way the current trial differs from prior studies, and said "we believe there are too many unknowns that prevent us from expecting success at final analysis next year." He maintained his sell rating on Dendreon.

    Brean Murray and Banc of America each makes a market in Dendreon shares.

    Whether or not Provenge succeeds or fails could prove meaningful for an entire class of cancer immunotherapies, which is yet to produce a successful product in the U.S. after numerous failures. Despite setbacks for the market at larger, several companies including IDM Pharma Inc. (IDMI), Progenics Pharmaceuticals Inc. (PGNX) and Antigenics Inc. (AGEN) are working to produce such drugs.

    Shares of all three companies declined on Monday following Dendreon's announcement, and amid a widespread swoon in the broader market. IDM recently traded down 15% to $1.74, Progenics was recently trading 3.4% lower to $12.35, while Antigenics shares were recently off 13.4% to $1.10.

    Once final results from Dendreon's study are submitted to the FDA, there is a six-month ceiling on how long the agency may take for its review, according to company officials.
  5. [verwijderd] 7 oktober 2008 02:09
    Dendreon's Move Still Leaves Many Questions (DNDN)

    Dendreon_logo Dendreon Corp. (NASDAQ: DNDN) was an incredible performer today, and one which makes you wonder how well it would have done had the stock market not been so ugly. Its interim data from Phase III PROVENGE IMPACT trial showed that the IDMC observed no safety concerns, and it recommended that the study continue. The company itself has completed the planned interim analysis of the Phase III, randomized, double-blind, placebo-controlled IMPACT clinical trial designed to assess the safety and efficacy of PROVENGE in men with metastatic androgen-independent prostate cancer. We do want to outline how that despite this data being good and despite it being an active day trader stock again, Dendreon is not suddenly a slam dunk and still has many risks associated with it.

    Dendreon remains blinded to the data, but the independent data monitoring committee reported to Dendreon a 20% reduction in the risk of death in the PROVENGE arm relative to placebo and observed no safety concerns and recommended that the study continue to its final analysis.

    The final analysis is expected in the middle of 2009 and if the study demonstrates approximately a 22% reduction in the risk of death (based on 304 events), the company would expect the study to meet its primary endpoint of overall survival.

    The data is mixed depending upon whether you are bullish or bearish on this and we are merely outlining why investors need to treated lightly before jumping in and making big bets here. For starters, it is more of a bet than an investment, just like it sounds. The company is still technically an at-risk company for the future. It is going to trade somewhat as a call-option in the fight against prostate cancer. It also has severe FDA issues, which are still outstanding and unresolved as of now.

    On the flip side, there are reasons to like it as well. Its data does keep it "in the game." It genuinely may be able to beat some of its opposition inside and outside the FDA. It may even get some added Congressional help in its fight. It does have an army of loyalists who are hoping for this to be the life extension it is meant to be.

    Investors and traders alike are going to be paying close attention to its progress. There will be many days where rumors or market chats get the stock moving up or down when no news has come out of the company. This was also just featured this weekend in our weekly "under $10 stocks" letter.

    Dendreon traded up 33% today to $6.93 on more than 35 million shares. At one point its stock traded north of $9.00. It traded more than 40,000 Call Option contracts today for the October current month expiration, it traded over 37,000 call option contracts for November expiration, and traded over 90,000 call option contracts for the January-2009 expiration. If you add all that up on a fully leveraged basis, you would see that this is equivalent to more than another 16.7 million shares.

    Stay tuned for more data as "later in 2009" is now much closer than it sounds.
  6. [verwijderd] 7 oktober 2008 08:35
    "Brean Murray analyst Jonathan Aschoff also raised some questions about the way the current trial differs from prior studies, and said "we believe there are too many unknowns that prevent us from expecting success at final analysis next year." He maintained his sell rating on Dendreon"

    dat is dus de grootste rat en liegende klootzak die er is

    in verleden al tig keer feiten verdraaid

    wel kand op additionele financiering bij goede resultaten
  7. [verwijderd] 7 oktober 2008 18:39
    Voor wie hier nog wil instappen en de rit van gisteren gemist heeft is dit nu het moment.
    Ondertussen zijn de longs onder ons er vandaag weer aan voor de moeite.Of moeten we ons enkel nog voordoen als dag toerist.
    Laatste koers Real-time: 5.92 Down 1.01 (14.57%)
    Day's Range: 5.92 - 6.77

    Buiten dit, doet het niets meer.Is het niet....????
  8. [verwijderd] 7 oktober 2008 19:37
    quote:

    skippy44 schreef:

    Voor wie hier nog wil instappen en de rit van gisteren gemist heeft is dit nu het moment.
    Ondertussen zijn de longs onder ons er vandaag weer aan voor de moeite.Of moeten we ons enkel nog voordoen als dag toerist.
    Laatste koers Real-time: 5.92 Down 1.01 (14.57%)
    Day's Range: 5.92 - 6.77

    Buiten dit, doet het niets meer.Is het niet....????
    doet geen flikker, 5,92 nog steeds.
  9. [verwijderd] 8 oktober 2008 17:16
    Pharma's Market Comments:
    Raeder Responce .
    Since there should really be no compelling reason to blog or report on Dendreon [DNDN 5.46 -0.14 (-2.5%) ] and Provenge for quite awhile, here's one last hurrah. Someone named Lindy writes, "The obvious manipulation of this stock...makes me ill!" And Jack Truman thinks I'm partially to blame for that. He says, "(You) have been pumping all along...you should be ashamed of yourself...you guys have been pumping this pile of crap right into the ground."

    Real-time: 5.34 Down 0.26 (4.64%)

  10. [verwijderd] 20 januari 2009 16:37
    quote:

    domus muris schreef:

    Is een beetje aan het oog ontsnapt. Weet iemand waarom hij zo gezakt is? Hij staat nu op $4.25. Is hij al op deze koers al interessant om in te stappen of is er wat aan de hand?
  11. [verwijderd] 20 januari 2009 17:01
    quote:

    Kieter schreef:

    [quote=domus muris]
    Is een beetje aan het oog ontsnapt. Weet iemand waarom hij zo gezakt is? Hij staat nu op $4.25. Is hij al op deze koers al interessant om in te stappen of is er wat aan de hand?
    [/quote]
    nou, interim data anlysis blijft spannend mbt statistiek wat anderen die er meer vanaf weten mij verteld hebben
  12. jurpsy 20 januari 2009 19:55
    quote:

    crackedtooth schreef:

    [quote=Kieter]
    [quote=domus muris]
    Is een beetje aan het oog ontsnapt. Weet iemand waarom hij zo gezakt is? Hij staat nu op $4.25. Is hij al op deze koers al interessant om in te stappen of is er wat aan de hand?
    [/quote]
    [/quote]

    nou, interim data anlysis blijft spannend mbt statistiek wat anderen die er meer vanaf weten mij verteld hebben
    Onderzoeken moeten verder gezet worden, resultaten worden nu pas mid 2009 verwacht!
    Volgens DNDN zijn de resultaten zeer bemoedigend , maar FDA wil méér zien!!...(dus : Delay.)

    Er moet ergens een medeling zijn geweest vorige week of de week voordien.

    suc6 , jurps

  13. [verwijderd] 20 januari 2009 20:52
    quote:

    jurpsy schreef:

    [quote=crackedtooth]
    [quote=Kieter]
    [quote=domus muris]
    Is een beetje aan het oog ontsnapt. Weet iemand waarom hij zo gezakt is? Hij staat nu op $4.25. Is hij al op deze koers al interessant om in te stappen of is er wat aan de hand?
    [/quote]
    [/quote]

    nou, interim data anlysis blijft spannend mbt statistiek wat anderen die er meer vanaf weten mij verteld hebben
    [/quote]

    Onderzoeken moeten verder gezet worden, resultaten worden nu pas mid 2009 verwacht!
    Volgens DNDN zijn de resultaten zeer bemoedigend , maar FDA wil méér zien!!...(dus : Delay.)

    Er moet ergens een medeling zijn geweest vorige week of de week voordien.

    suc6 , jurps


    Ik ben blij dat ik ze nog even niet gekocht heb. Maar wanneer dan wel vraag ik mij af als je de dalingen van de laatste twee dagen beziet?
  14. jurpsy 20 januari 2009 22:00
    Dendreon Update

    In a follow-up to my post from late last week, shares of DNDN [DNDN 3.63 -0.62 (-14.59%) ] hit a new intra-day low this morning.

    Jonathan Aschoff at Brean Murray Carret & Co. put out a research note to clients this morning to "strongly reiterate" his sell rating and price target of a buck. He believes the earlier-than-expected milestone reached in the pivotal clinical trial of the company's experimental prostate cancer treatment isn't bullish for the final results now expected in April. Brean makes a market in DNDN and would like to do investment banking for the company. But despite the wall that's been put up between research and banking, I can't imagine Dendreon--or any company for that matter--giving a firm with that kind of bearish position the business, so to speak.
  15. [verwijderd] 21 januari 2009 13:13
    quote:

    jurpsy schreef:

    Dendreon Update

    In a follow-up to my post from late last week, shares of DNDN [DNDN 3.63 -0.62 (-14.59%) ] hit a new intra-day low this morning.

    Jonathan Aschoff at Brean Murray Carret & Co. put out a research note to clients this morning to "strongly reiterate" his sell rating and price target of a buck. He believes the earlier-than-expected milestone reached in the pivotal clinical trial of the company's experimental prostate cancer treatment isn't bullish for the final results now expected in April. Brean makes a market in DNDN and would like to do investment banking for the company. But despite the wall that's been put up between research and banking, I can't imagine Dendreon--or any company for that matter--giving a firm with that kind of bearish position the business, so to speak.

    achcoff= voice van de shorters in DNDN
    in verleden ook veel items bewust verdraaid, tot aan de dag van de panel decision toe
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