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Dendreon Anonim Ortaklik Message Board

  • adeiflig adeiflig Mar 4, 2009 4:38 PM Flag

    Update from DNDN IR inside....

    Hello xxxxxx-
    My answers are below. I hope they are helpful to you.
    Best regards,
    -Jennifer

    _____________________________
    Jennifer Cook Williams
    Investor Relations
    Dendreon Corporation
    (206) 829-1500
    jwilliams@dendreon.com




    --------------------------------------------------------------------------------
    From: xxxxxxxxxxxxxxx[mailto:xxxxxxxxxxx]
    Sent: Sunday, March 01, 2009 7:27 AM
    To: Investor Relations
    Subject: Question


    Hello,

    I am a holder of Dendreon shares (x,xxx shares in total to date).

    I have a few questions:

    a) If Provenge results show 22% in April 2009, does DNDN file a new Drug application or an amended BLA application with the FDA?

    Yes, our plan would be to amend our BLA with the FDA in light of a positive result, i.e., 22% reduction in the risk of death.

    b) Always assuming it is positive, how long after the April results would DNDN file these applications?

    As quickly as possible, but we would be discussing our filing plans with the FDA and would then proceed with our amended BLA filing, should that be appropriate.

    c) What is time frame for FDA approving this once application once it is filed?

    We would have a six-month clock with the FDA once our amended filing is submitted.

    d) If Provenge results show only 20% as at interim in October 2008, are you still going to file Drug application or amended BLA or, is that it for Provenge?

    It is hard to project that without seeing the data, but I can assure you that if we are in a "near miss" situation, we would certainly be having conversations with the FDA about what our options are. Keep in mind also that a sensitivity analysis will be done, which will include additional patients, so we may have that to discuss with the FDA as well.

    e) Once nasty analyst Ascroft has a $ 1/share target, says that event 304 occurred too early and that DNDN will not hit 22%? Any truth to this?

    We announced a few weeks ago that patients on the IMPACT trial are behaving very similarly to those in our D9901 trial, so the overall death rate in the study is tracking where we had predicted it would, so I can tell you that there are no red flags in the trial at this point that lead us to be discouraged.


    Thank-you for your responses,

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    • yoou people are really ignorant, your claiming hearing things through the grapevine, oh so and so is going to buy us out, $30 a share and even more ignorant idiots 5 star it, well i want a million dollar house, a nice boat, a jet ski, five cars, miss america for my wife, maybe a nice dog also, but you know what, im a realist, my chances of getting all of those is slim to none, you idiots know nothing, your hoping for $30 but when the announcement comes a realist knows it will be under a buck or around 5 to 6 bucks so you better get real

    • Excellent post.

      For me the most important part was:

      >>>>e) Once nasty analyst Ascroft has a $ 1/share target, says that event 304 occurred too early and that DNDN will not hit 22%? Any truth to this?

      >>>>We announced a few weeks ago that patients on the IMPACT trial are behaving very similarly to those in our D9901 trial, so the overall death rate in the study is tracking where we had predicted it would, so I can tell you that there are no red flags in the trial at this point that lead us to be discouraged.


      The fact that the IMPACT trial is tracking so closely, even with patients with Gleason scores above 7 is excellent.

    • Through the grapevines, hearing that Lilly is preparing a $ 3 billion bid for DNDN.

      • 1 Reply to adeiflig
      • DNDN hits the 22% survival number. $30 per share IMHO is a little low! Their worldwide patented Antigen Cassette Technology is worth at least a billion all by itself. Provenge has the potential within three years of going from ~2 Billion worldwide sales to ~$10 billion in sales add to it Neuvenge for breast/ovarian cancer and later trp-8 small molecule for multi cancers and you can see why most think dndn is the next amgn,biib or DNA. IMHO I think it has more upside potential than any of the above three! IMHO Gold would not consider $30 per share. $40 maybe.

    • Thanks for posting the information.