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orphan drug status - secret to prr success

  1. 221 Posts.
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    I think there is some confusion on why PRima can be a lot more successful commercially than Dendreon

    It's ovarian cancer and orphan drug. Prostate cancer(what Dendreon has developed a cancer vaccine for) is not in this category and ovarian cancer is

    www.fda.gov/orphan/oda.htm - US congress 1997

    Basically Prima can do a pivotal trial on less patients and less cost, it gets fast tracked in the FDA. Dendreon took 4 years and $325M. Prima can take a lot less time and for a fraction of patients and thus a fraction of the cost(about 1/10th)! The statistics of the trial are also treated more favourably so that much needed treatments for rare diseases or diseases that have no treatment are encouraged to be invested in to come onto market.

    Also if you read on orphan drug status the patent life is extended by 7 years in the US and 10 years in Europe after it is first on market. This means patent life is until 2025 in the US.

    Most importantly ovarian cancer is more dire as there is no treatment compared to prostate cancer which has many treatments but is certainly not critical. The stat of every 48 men who have their prostate surgically removed only 2 had metastatic diseases. 10% chance of survival for ovarian cancer patients after 5 years. Bottom line is that ovarian cancer vaccine will generate a lot more sales than a prostate cancer vaccine because of the need.

    A lot of HC posters have made good money over the past few days but the best money is to understand the story and hold long term. IPD(impedimed, breast cancer) also has a great commercialisation story. good luck and DYOR
 
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