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Mooi instap moment Dendreon

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  1. [verwijderd] 12 april 2007 22:14

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    quote:

    ludwig mack schreef:

    [quote=psycho-pharma]
    18.01
    --1.21% (--22 cents)

    42.500.000

    P.
    [/quote]

    wat is jouw tactiek spycho, hoe ga jij met deze koersen om, en verkoop je voor def. goedkeuring en trade je ?
    gr
    Ik ga heel goed met deze koersen om, wetend waar ik vandaan kom.
    Ik trade nooit. Ik doe wel eens afstand van een aandeel om diverse redenen.
    Ik koop in principe voor een termijn van ong. 3 jaar.
    Dus nu ook.
    Ik blijf zitten, ook omdat ik denk dat Provenge gewoon goedgekeurd wordt (met een fase IV).
    De methode is uniek, nieuw en zonder veel bijwerkingen, ook een reden om het goed te keuren.

    Psycho
  3. [verwijderd] 13 april 2007 09:32

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    Tja,moeilijk iets tegen in te brengen.

    Yahoo board

    FDA is telling you loud and clear: Provenge will be Approved! (7 Ratings) 50 minutes ago

    The FDA put all these eyes and scrutiny on DNDN. The short funds were not paying attention.

    When the FDA announced that the CBER panel was getting the BLA they should have covered and hedged. Even Cramer admits this. That was the sign that the FDA wants Provenge approved. When the FDA director spoke at the NCI conference in February he said immunotherapies were "right around the corner", but the shorts were not listening.

    So the attention is intentional. The FDA wants this attention. It wants new drugs to treat cancer in the market and developed, and it knows that it has to approve Provenge so that money will flow to new ideas in cancer research. Heck, CEGE was able to place 11 million new shares just from the bump it got from the Provenge attention. This is exactly what the FDA wants! Shorts and naysayers are blind because they refuse to see!

    For decades, when it came to cancer The FDA has been ruled by the CDER, and all that the CDER has done is approve very toxic drugs that meet TTP endpoints, even if they do not extend survival. You heard it yourself at the panel, with the CDER people talking about endpoints all day and avoiding the issue of survival advantage or quality of life. Only the immunologists were talking about quality of life.

    Yet everyone knows that endpoints are meaningless if they do not help people live. Who cares if your cancer slows for 12 weeks, but you are sicker than you have ever been for 30 weeks, and die just as quickly, and give your family misery and heartache, and cost a fortune in medical bills to treat symptoms like vomiting, dehydration, excessive bleeding, heart attacks etc from Chemo?

    The idea that TTP delay at week 12 means anything is just stupid!

    So when the FDA gave the BLA to the CBER, they were telling the CDER, and the world, that the FDA is going to be more proactive. This is a political, medical, scientific and financial issue. Chemo costs more in terms of quality of life, hospital bills, and suffering for family members. More importantly the boomers are getting to the age of cancer, every boomer knows someone who had a horrible last year on earth from cancer, and they want something safer, with lower side effects, that can help them live. They don't want to suffer, and they don't want loved ones to suffer watching them die a painful death in the slim chance chemo will work.

    FDA clearly wants Provenge approved not only because Provenge extends lives, but because this will encourage more investment in safer therapies. It will tell the world - and the CDER - to shift emphasis from meaningless data like endpoints and focus on issues such as outcome, quality of life, and overall cost financial and emotional. Remember, Medicare pays for almost all of this, so abandoning Chemo for Immunotherapy will save the government a fortune in incidental costs such as hospital stays, cardiology, lack of productivity etc.

    Shorts were stupid. They did not only not see, they refused to see. The shorted even when the stock was $3.70 cents! With so little upside they kept shorting. They demanded that they were right to the bitter end even as the FDA was clearly telling them they were wrong.

    There is no way the FDA turns this down. The FDA will approve Provenge, with the request that it receive regular updates on the 9902b trial. Not "conditional approval" but simply they want to maintain their close relationship with DNDN to learn as much as they can as this will help them evaluate future, similar immunotherapies for cancer and other diseases.

    P.
  5. [verwijderd] 13 april 2007 10:02

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    Nog even dit lezen en dan zijn we allemaal weer bij:

    caps.fool.com/Blogs/ViewPost.aspx?bpi...

    ..........."The conservative estimates put the market over a billion per year for this drug in its INITIAL market (Androgen Independent Prostate Cancer [AIPC], a cancer that has metasticized but in which the patient is currently not showing symptoms). The company obviously is researching giving patients the drug earlier (i.e. to less sick patients in hopes of helping them at an earlier stage) so this would potentially take them to the Androgen Dependent [ADPC] market, which is approximately four to five times the size of the AIPC market. Once you establish the market size, think about what you feel is a reasonable price to sales multiple and then back into the price per share you would be left with (85 million or so shares outstanding at this point). My own estimates suggest $40 per share is a VERY conservative estimate after approval."..........

    P.
  7. [verwijderd] 13 april 2007 10:55

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    quote:

    ohmygod schreef:

    Deze zin zegt alles:

    FDA clearly wants Provenge approved.
    [/quote]

    Author has a long position in DNDN

    Tja, wat wil je dan dat hij zou zeggen ?

    Ik ben op mijn bek gegaan met GTCB, INSM en ENCY. Een aandeel waar velen niet hadden verwacht dat het zou goedkeuring krijgen ( gezien de grote shortpositie ), dat knalt dan omhoog. Ik durf hier niet in te stappen, tenzij misschien dat we terug veel lager gaan. Allen die volharden succes gewenst.

    Luister eens naar de video van Cramer :
    "Find the next Dendreon"
    tinyurl.com/289oy8

  8. [verwijderd] 13 april 2007 13:19

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    Jom, ik moet me erg vergissen als we de bodem niet hebben op 17.50-18.00.
    Gisteren ondanks groot geweld bijna op de beginstand geeindigd.
    Ik denk, dat we vandaag beginnen aan een langzame klim naar 15 mei (tot ik schat $35).

    En je weet het, garantie tot aan de voordeur voor jou, maar ik ben al lang zeker van een tickertape parade op Broadway/5th op 15 mei.

    Psycho
  9. [verwijderd] 13 april 2007 14:23

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    quote:

    psycho-pharma schreef:

    Jom, ik moet me erg vergissen als we de bodem niet hebben op 17.50-18.00.
    Gisteren ondanks groot geweld bijna op de beginstand geeindigd.
    Ik denk, dat we vandaag beginnen aan een langzame klim naar 15 mei (tot ik schat $35).

    En je weet het, garantie tot aan de voordeur voor jou, maar ik ben al lang zeker van een tickertape parade op Broadway/5th op 15 mei.

    Psycho
    Ik wens het je van harte Psycho ! Blijf je zitten op 15 mei ?
  10. [verwijderd] 13 april 2007 14:36

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    quote:

    Jommeke schreef:

    Ik wens het je van harte Psycho ! Blijf je zitten op 15 mei ?
    Yes, en daarna tot de overname (ik verwacht sept/okt rond de 70) dan wel tot de koers op 100 staat (10K).
    De andere 10K zie ik wel, wanneer ik daar iets mee doe en wanneer.

    P.
    handel voorbeurs nu op 18.70
  12. [verwijderd] 13 april 2007 21:03

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    www.lef.org/magazine/mag2005/jun2005_...
    (lef=lifeextension)

    Stuk uit 2005!!!!
    (Het wordt steeds duidelijker,dat Provenge goedgekeurd gaat worden.)

    FDA Delays Promising Prostate Cancer Vaccine

    Scanning electron micrograph of prostatic cancer cell, magnified 6,000 times.
    In 2004, Life Extension reported on a Phase III study showing that men with metastatic prostate cancer who received an immune-boosting vaccine called Provenge™ were eight times more likely to live six months without disease progression than those who did not receive the vaccine.1 This anti-cancer vaccine, however, was effective only in men with a Gleason score of 7 or less. (Higher Gleason scores are indicative of a more aggressive type of prostate cancer.)

    The FDA refused to accept the study results because the agency does not allow retrospective analysis of a subgroup that may have benefited from an experimental drug. To gain FDA approval, Dendreon, the company testing the vaccine, was forced to begin a new study on men with Gleason scores of 7 or less. However, Dendreon continued to follow patients in the original study, and the results continue to be impressive. Of the 75 patients who entered the trial with a Gleason score of 7 or less, those receiving Provenge™ were 3.7 times more likely to be alive after 30 months; this translates into 53% of the Provenge™ group staying alive compared to only 14% of the placebo group. The Provenge™ group also remained pain-free twice as long on average as the placebo group.

    A Wall Street Journal editorial commented on the FDA’s deplorable delay by stating:

    “We know that it works, and we know why it works. In any rational regulatory environment, that would be reason to speed Provenge™ to market. But this is the FDA we are talking about.”2

    Fast forward to 2005, and the results of a new clinical study on Provenge™ show that three times as many advanced prostate cancer patients who received Provenge™ were alive compared to patients receiving a placebo.3 This study evaluated 127 patients with prostate cancer that did not respond to androgen-deprivation therapy (that is, hormone-refractory prostate cancer). Cancer experts consider this patient subset to have a dismal prognosis, with most dying of the disease within a few years. In the Provenge™ study, 34% of the patients receiving Provenge™ were still alive after three years compared to only 11% of men who were randomly assigned a placebo.3

    Under FDA regulations, pros-tate cancer patients with such a dire prognosis had to risk receiving no therapy (the placebo) in the hope that they might be lucky enough to be in the study arm that received the promising drug (Provenge™). Life Extension has advocated that cancer patients with advanced disease should not have to risk receiving a worthless placebo. Historical controls could be used instead of placebos to spare such patients almost certain death.

    Prostate cancer kills more than 30,000 American men every year.3 Provenge™ has clearly demonstrated that it improves survival rates, yet the FDA still has not approved it. Considering that the FDA could have approved Provenge™ as early as 2002, the agency’s delay in approving this one drug alone may have resulted in the premature death of tens of thousands of men.

    —William Faloon

  16. [verwijderd] 13 april 2007 23:37

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    Investor Village offers slightly more intelligent postings although they have a group of professionals working it over there as well, however, we know that the bottom of the barrel gets to come here. LMAO

    FWIW_ here it is.

    "By: joyfulsteward Send PM Profile Ignore Recommend Add To Favorites

    What Have I Missed?

    I guess while I wasn't looking a bunch of complete idiots were put in charge of the FDA. At least that is what I am hearing from the shorties' puppets. After all that has happened the decision makers at the FDA are going to deny a treatment to terminal cancer patients and suffer all of the political heat that goes with such a decision. How stupid could they be? Why did they squander all of the opportunities to derail the Provenge train with much smaller political and public relations fallout. Let's review a couple of them:

    1. In the meetings with Dendreon before their decision to file the BLA, the FDA could have simply said, "Not good enough, better wait for 9902b."
    2. They could have demanded the full application fee rather than waiving it. That would have put at least a small hurdle in DNDN's way.
    3. They could have denied the priority review request and required DNDN to wait until what, October?
    4. They could have put more anti-Provenge people on the AC panel.
    5. And when the votes on the poorly worded efficacy question were coming in as "No's," why didn't they just sit back and get a majority no votes or at least a seriously split panel. Now they have to deal with the fact that 13 of 17 of their picked experts agree that there DNDN has shown substantial evidence of the efficacy of Provenge.

    The FDA has seen the data for months now. Why would they blow all of those opportunities to provide the cover to issue an approvable letter with much smaller costs? Why did they compound the political and ethical problems of telling the cancer patients, "Not now, we need to see more data."?

    I may me wrong but the simple answer is that the FDA has no intention of delaying approval. They didn't seek cover because they don't need it. Provenge extends the lives of some dying patients while doing no harm. That is the FDA's and the medical establishment's mission--their reason for existence. There will be no approvable letter, in my opinion. The simple answer is often the correct one."

    P.
  17. [verwijderd] 15 april 2007 12:03

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    Voor de statistici onder ons. Van Yahoo:

    Why DNDN get approved 5/15 or before (1 Rating) 15-Apr-07 04:49 am a) Trial 9901 overall survival doubled the median survival of the only other approved treatment. It tripled the likelihood that a patient would be alive after 3 years.
    b) 9901 missed its primary endpoint of TTP by only .002 percent. (.05 vs .052)
    c) 9902a (with prespecified cox regression variates coordinated w/ FDA beforehand) was stat significant at .023 and showed similiar median survival rate as 9901 (4.3 months vs 4.5 months 9901).
    d) Both 9901 and 9902a TRENDED TOWARD IMPROVEMENT (or numerically beat the placebo arm) IN ALL ENDPOINTS including TTP and onset of pain.
    e) Patients receiving Provenge in both trials lived 3 times as long as patients who received the placebo.
    f) Flu like symptoms are the only side effect. (CVAs were not statistically signif and further vigilance has already been agreed upon between DNDN and FDA.)
    g) And most important--THERE IS NO ALTERNATIVE CURRENTLY AVAILABLE OTHER THAN TAXOTERE--A DRUG WITH WEAK POSITIVE EFFECT AND STRONG SIDE EFFECTS.

    NOTE: Analyze and take these trials apart any way you want-the bottom line is that OVERALL SURVIVAL CANNOT BE DISPROVED. That in itself is the reason Provenge gets outright approval by May 15.

    P.
  18. [verwijderd] 15 april 2007 22:18

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    Van Yahoo Finance:

    On Monday morning Dendreon will be presenting data in a poster session on the significant increase in the immunotherapeutic index one single booster shot of Provenge provides to androgen dependent prostate cancer patients. This data will boost both the potential benefit of more Provenge is better than less Provenge for fighting prostate cancer and more Provenge is better for revenues than less Provenge.

    If I were an oncologist, and I am not a medical anything, but if I were I would be wondering just how much Provenge should I administer to my patients to help them gain the best chance possible to live as long as possible with as high a quality of life as possible. The answer is nobody knows. But, the data presented Monday will indicate it not only can't hurt to give more than three infusions, it might in fact help to give a booster shot, it might even help a lot. If I were a practicing oncologist or a prostate cancer patient, I would want to take as much Provenge as I needed to boost my chances to be the next Eduardo Garcia.

    The rumor is Provenge might be priced at $20,000 per infusion. Some say $10,000, some say $15,000, some say $20,000 and some say more. The revenue models used by Adam and others in the financial community do not include a fourth, fifth, or sixth infusion of Provenge. After Monday morning, all revenue models will need to factor in booster shots.

    In the advisory panel presentation a question came up about the cost of Provenge and providing access to it to those who could not afford it. Dendreon made the statement they were working to make sure all who needed Provenge would have access to it regardless of their financial ability to afford it. This means Provenge will be provided just like all health care services in the U.S. are provided, those that can pay will pay for themselves and the additional costs associated with those who can not pay, just like hospitalization costs.

    In my way of thinking, this will require Provenge to be priced at the upper range of forecasted pricing or Dendreon will not be able to afford a charitable program. Most men will be able to afford something because Medicaid and Medicare are the two largest payers of late stage cancer drugs in the U.S. So if only a fourth infusion is calculated into every one's revenue model, then the models need to be boosted by at least 33%. Is there any doubt Provenge is actually a $2 billion plus drug in the U.S. alone? None. I have already presented a revenue model incorporating an annual booster shot that potentially drives U.S. Provenge revenue closer to $10 billion.

    Now, the stock may trade towards $15 or $25 early next week, but post FDA approval Monday's presentation will significantly boost the revenue models for Provenge. Monday morning will represent the first piece of actual new news since the FDA advisory panel voted overwhelmingly yes on March 29.
  20. [verwijderd] 16 april 2007 14:23

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    Het is hier allemaal rozegeur , maar kijk ook eens naar onderstaand bericht:

    Dendreon's Provenge Ripped Apart By ODAC Member
    Monday April 16, 5:40 am ET

    PharmaTracker submits: The Cancer Letter, a weekly oncology paper (these are the guys who broke the ImClone (NasdaqGS: IMCL) story all those years ago, back when Inmate Waksal was spinning his lies), published an article on Dendreon (NasdaqGM: DNDN) and the Advisory Panel review of Provenge. They also published a letter to the FDA from Howard Sher, a major urological oncologist from Sloan-Kettering and a member of the Oncology Drugs Advisory Committee. Dr. Scher sat on the Provenge review panel and voted against Provenge on the question of substantial efficacy.
    ADVERTISEMENT


    Below are excerpts from his letter - but there's a lot more in the Cancer Letter worth reading. I think the likelihood that the FDA will not ask DNDN for additional data from the ongoing survival trial is small - though I'm confident that the trial will fail; if you are long, is it really worth waiting a couple of years to find out? Not while the CEO sells every share he owns . And don't forget the capital raise that is certain to be coming. May 15th we'll see a Complete Response letter from the FDA, with a request for an additional trial, and the DNDN bubble will burst.

    One thing is sure, from the panel vote and from this letter - even if it were to get approved, it sure doesn't look like oncologists want any part of this treatment. Maybe DNDN will have better luck selling it to the lab jockeys, PhDs and veterinarians on the advisory panel who voted for approval.

    Onto Dr. Scher's words to the FDA; he's a lot more articulate and authoritative than I am:

    I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency. All but the latter were discussed in the open meeting, but warrant further consideration given the outcome. The concerns are based on my experience as a voting member on several ODACs representing the Agency, and separately, as a Presenter to ODAC for Industry Sponsors. I have been one of the Academic Leaders of the Prostate Cancer Clinical Trial Endpoints initiative begun under the joint Sponsorship of the FDA, AACR, ASCO and PCF in 2004, which were presented at the February 2007, Prostate ASCO Meeting in Orlando.

    . . . .

    Let me state at the outset that I was one of the four Committee Members who voted “no” to the question whether the trials presented by the Sponsor established the efficacy or demonstrated substantial evidence of benefit to justify an approval recommendation to the FDA. My vote was based on the fact that neither of the two trials presented met their primary endpoint, which renders the significance of results from any subsequent analyses as “exploratory” and “hypothesis generating.” As such, theresults do not constitute “proof” of benefit or justify a conclusion that they are “reasonably likely” to predict benefit. The trial data were not consistent. Even if one accepts the posthoc survival analysis results of the larger 127 patient trial (82 men treated with Sipuleucel-T and 45 men treated with a “placebo”), the second trial of 98 patients (65 treated with Sipuleucel-T and 33 with placebo) was not confirmatory. Consequently, the only conclusion that can be reached is that the survival difference observed may have occurred by chance alone, and that the results do not support an approval recommendation. This, and the Sponsor’s recognition that an additional prospective study was needed, mandates deferring any decision on whether an approval should be granted until the results of the ongoing 500 patient phase 3 trial that is powered on a primary endpoint of survival, is accrued and analyzed.

    Concerns about the validity of the findings were reinforced by the absence of other signals of an antitumor effect. Specifically there were no data provided of a favorable effect on PSA, regression or stabilization of soft-tissue or boney disease radiographically, health related quality of life, or that administration of the product delayed the development of pain. Even the time to the administration of chemotherapy, an indication to the treating Physicians that the clinical course had worsened, was similar between the two groups. Reinforcing the uncertainty was the fact that in response to a direct question at the meeting, none of the Physicians representing the Sponsor could articulate how treatment with the product had “helped” any individual patient.

    . . . .

    Finally, the original question posed by the Agency to the Advisory Committee at the meeting was: “Does the submitted data establish the efficacy of Sipuleucel-T (APC-8015) in the intended population?” The first 4 respondees on the Committee voted “no.” The question was then changed to: Do the data show “substantial evidence.” A series of “yes” votes followed. Consider the conclusion in the manuscript describing the results of trial 9901, published in the Journal of Clinical Oncology in Volume 24, page 3093, in 2006.(JCO 24:3089, 2006) In it, the Investigators state “that while sipuleucel-T fell short of demonstrating a statistically significant difference in TTP, it MAY provide a survival advantage to asymptomatic HRPC patients. Supportive studies are underway to confirm this effect.” All of the difficulties cited, and the Investigator’s own conclusions, show how there are simply too many alternative explanations for the observed survival difference beyond treatment with Sipuleucel-T. Couple this with that fact that were no secondary signals of an antitumor effect and no confirmatory trial however flawed, mandates that any decision for approval be deferred until the phase 3 study, currently underway, has been completed and analyzed.

    Disclosure: Author has a short position in DNDN

    Research Stocks and ETFs: Type in stock symbol to get opinion and analysis, earnings call transcripts, quote and chart:


  21. [verwijderd] 16 april 2007 14:46

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    Ach Knut, onderhavige dr. Scherr zat in de commissie die de voordracht aan de FDA deed over Provenge.
    Hij komt nu met allerlei bezwaren aan, die hij niet tijdens de meeting gaf. Interessant is dat hij negatief is over de veiligheid van Provenge, terwijl hij voor de veiligheid gestemd heeft (17-0 weet je wel)(zie orginele brief in The cancer letter).
    Nog leuker is, dat hij bij de makers van Taxotere een concurrerend middel van Provenge aan het maken is, een onderzoek over bijna 1000 patienten in 10-tallen landen met als meetlat Taxotere.
    Dus: hij zit diep in een concurrent EN hij mag zijn onderzoek aanpassen door het af te gaan meten aan Provenge, als dat goedgekeurd wordt.
    Dus gewoon ernstig balen voor hem.
    Trouwens DR. Ronald de Wit van het Erasmus Ziekenhuis is medeonderzoeker bij hem. Die zal ook wel blij wezen dat Scherr door deze brief vrijwel zeker uit de FDA gegooid zal worden.
    Scheer heeft dus op een aantal plekken veel boter op zijn hoofd, evenals de schrijver (een shorter) van het artikel.

    The war is on!!!!

    Psycho
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Apple 5 383
Arcadis 252 8.780
Arcelor Mittal 2.033 320.724
Archos 1 1
Arcona Property Fund 1 286
arGEN-X 17 10.305
Aroundtown SA 1 219
Arrowhead Research 5 9.744
Ascencio 1 28
ASIT biotech 2 697
ASMI 4.108 39.187
ASML 1.766 107.510
ASR Nederland 21 4.496
ATAI Life Sciences 1 7
Atenor Group 1 491
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 13.675
Axsome Therapeutics 1 177
Azelis Group 1 64
Azerion 7 3.392