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Aeterna Zentaris Inc. Message Board

  • dcaf7 dcaf7 Mar 29, 2013 8:08 PM Flag

    We need a new tread

    "OK - agree with you about Doxyrubicin but I thought that as of recently Doxil was back on the market (someone else was approved to make it...) so I thought that we were back to the original trial design. No matter what - as long as we show non-inferiority with much better toxicity then we will be approved and the market will be large"
    "No matter what" is not good enough for FDA. If we want the drug to be approved, we need the toxicity to be a primary endpoint in a new designed phase 3 trial. Of course, if the OS is not compromised.

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