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Zalicus AŞ Message Board

  • wildbullus wildbullus Sep 11, 2013 12:40 PM Flag

    Why Corrigan can peek safety data, not the efficacy data?

    This is double blind study. Why Corrigan can peek safety data, not the efficacy data? If Z160 can reduce pain significantly, Corrigan should know by now without going through statistics.

    Sentiment: Strong Buy

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    • mark_in_los_angeles_90049 mark_in_los_angeles_90049 Sep 11, 2013 1:22 PM Flag

      Adverse events would become immediately known.

    • Take a listen to the Webcast when he is talking about the Chung Model.

      "Preclinical data for Z160 is suggestive of efficacy on par with ziconotide, gabapentin, and morphine. The data below is from a spinal serve ligation (Chung) model, one of the most commonly used neuropathic pain models for preclinical testing. Zalicus has confirmed that Z160 exposure in humans exceeds the minimum efficacy levels for this neuropathic pain model."

      Sentiment: Strong Buy

    • He can't peak at safety data. DMC routinely takes a look at the data. If they allow the trial continue, you can extrapolate from that that no major safety issues have arisen. So Corrigan can safely say there are no major safety concerns with the current trial since it continues to get the green light. Additionally, I'm assuming he's also counting safety data from the previous P2 trial as well as P1.

      • 1 Reply to hwsimpsonshero
      • Exactly. As long as trial is moving forward, this means no major safety issues. Otherwise it would have been halted. This is true for any trial.

        Based on past trial data and continuation of this trial, it is safe to say there will be no safety issues.
        It's all about the pain score.

        Now, trying to read between the lines and decipher the webcast, what does the quote below mean? What makes a trial run efficiently???

        From press release on trial enrollment completion. "We are pleased with how efficiently these trials have been conducted and look forward to evaluating and reporting the activity of Z160, with its novel mechanism of action".