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Dendreon Anonim Ortaklik Message Board

  • andraaklly andraaklly May 6, 2009 10:32 AM Flag

    Oncologist opinion -- it will not get approved

    I just went to a prostate oncology presentation, and what I feared was confirmed -- oncologists do not like this drug because it is a pain in the ass, and is very expensive. Oncologists love Taxotere because it reimburses well and is easy to give, and they are used to it. Provenge is so different, and requires a lot of effort from oncologists to give, and they are quite overworked. It should be approved based on the data and FDA promises, but to me oncologists seem to want it to just go away -- and in fact hope it doesn't get approved because then they might be forced to offer it, and it is a huge financial and resource drain.

    The FDA is influenced by public opinion, namely by the medical community, and there hasn't been a groundswell of support by oncologists themselves. For example, the presentation of the data was at AUA, not at ASCO -- which all the oncologists attend. If DNDN can't find a receptive audience among oncologists, who do they think is actually going to administer the drug? Presenting data to a bunch on urologists is useless and shows that DNDN has a problem -- this is a "drug" that nobody wants, even if it does improve survival.

    So I do not think that the FDA is going to approve the drug without general support by the oncology community. Oncologists are making excuses saying that "they want more data," "they want the data to be mature," etc. Really, they just see this as a pain in the ass for themselves and don't want it approved for their own selfish reasons (trust me, I am one of them). The FDA will cave in to this pressure. Trust me. They will double cross DNDN just like they double crossed GPC biotech with satraplatin -- saying they will approve based on these exact conditions, then not approving when those conditions were in fact met.

    So the only hope is a groundswell of public pressure on the FDA. There was a small amount of this two years ago when the FDA went against its own panel, but there needs to be a lot more. DNDN needs to do encourage this. Press releases, interviews, oncology presentations. Where was all the press around the AUA meeting release? None. Think of all the press around the recent anouncement that PSA screening was not useful (bullshit by the way). There was no press on DNDN except on CNBC and by investors. The FDA doesn't care about investors. You all think that two years ago the FDA didn't approved because of pressure from hedge funds, but that is B.S. -- they didn't approve because no one in the oncology community wanted it approved. They still don't. DNDN needs to do a lot more to pressure the FDA into approving, because it can't rely on the medical community.
    I was long on DNDN but sold. I don't see DNDN doing it. It's not getting approved. They need big pharma and their PR machine to do this. Dr. Gold wants to get rich and do it himself, but I don't think it's going to happen.

    Oncologist in Texas

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