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Dendreon Anonim Ortaklik Message Board

  • bbenzo1 bbenzo1 Jun 18, 2013 11:26 AM Flag

    Why you all so sure it will be approved in EU?

    They are cheap there and don't care about life as we do. There, it is all about money... and yes financially Provenge can be justified. The question is are they open minded enough to see the bottom line; no chemo, short treatment etc. That said I am not wanting to place all my eggs in the EU basket. I feel better about Provenge being a combination therapy with big pharm right here in the USA. I'm afraid we place all our faith in this EU thing, don't get approved and we tank. This of course would be short term as big pharm, as you know, needs this in combination with their poisons. I am cautiously optimistic but it will not be a death blow to be rejected. EU is way behind the times. Obviously approval is a home run.

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    • US FDA required extensive and multiple years of data and review before initial approval. EMA cancer guidlelines place an emphasis on survival endpoints (see EMA site). They also seem to like biomarkers. EMA typically follows the U.S. lead and can rely on the U.S. data. As backup, the company has the EU mfr studies in progress. They may ask for post approval studies to better define areas of interest such as biomarkers. My concern is if Dendreon is trying to move forward in EU with automation. At this point, I'm speculating. They might need the FDA approval first or need completion of the EU manufactrung studies to significantly change from the US based FDA approved manufacturing conditions or indications. This could delay, but not impede eventual approval in my view. I believe the Germans were pioneers in cancer vaccine therapeutics,

    • They are cheap there and don't care about life as we do. There, it is all about money

    • Because:
      1/ Provenge saves life.
      2/ Immunotherapy is the future treatment for cancers.
      3/ It's non-toxic and improve quality of life for patients.
      4/ Price per treatment will be negotiable as Dendreon will either contract out, or roll out automation, to produce vaccine.

      Sentiment: Strong Buy

      • 2 Replies to havenger2001
      • jeff@aksarbenappraisal.com jeff Jun 18, 2013 1:19 PM Flag

        "Because:
        1/ Provenge saves life.
        2/ Immunotherapy is the future treatment for cancers.
        3/ It's non-toxic and improve quality of life for patients.
        4/ Price per treatment will be negotiable as Dendreon will either contract out, or roll out automation, to produce vaccine. Less"

        Isn't all that true in the states to? So.......Why is it barely hanging onto the 4 dollar mark then? Hello, McFly, anyone home?

      • I know all the reasons, that's why I am an investor. I am just wondering if EU will see it that way. Pill popping cheap mothers. I just don't want to put the share price in their hands and make it such an important event.