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Zalicus AŞ Message Board

  • scistats scistats Sep 15, 2013 4:23 PM Flag

    Captain's Four Outcome 'Built to Win' Matrix: The two Z160 trials.

    Captain's Four Outcome Matrix
    'Built to Win'

    There are essentially 4 outcomes (-Jason Napodano):
    1. Both positive
    2. LSR positive / PHN negative (highly unlikely outcome)
    3. LSR negative / PHN positive
    4. Both negative

    All things being equal, #4 has a 25% chance.

    Sentiment: Strong Buy

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    • what is our chance of getting number 1 - both positive

      • 1 Reply to pharmahero782
      • In humans, Merck found efficacy for third molar extraction with very high doses of NMED160, the equivalent of which is now easily achieved by Z160 at 375mg BID (twice a day). Z160 has 6X more bioavailability than NMED160 thank to the help of a German formulation lab. In rats, Z160 is equivalent to morphine. Z160 has the same target as Prialt (Ziconotide), which relieves opioid breakthrough pain, but must be administered using an intrathecal pump. Lumbosacral radiculopathy and postherpetic neuralgia are much more appropriate indications for Z160 than third molar extraction (see video on Zalicus website). I would say the chance of both trials meeting their primary endpoint of =30% pain reduction is good. By the end of the week (Friday, September 27th), the lumbosacral radiculopathy data will be in Zalicus' hands. It is reasonable that Dr. Corrigan will release top line results for this phase 2 trial on or before October, 7th 2013.

        Sentiment: Strong Buy

    • For a guy with "stats" in his name, you are making one heck of a statistical error with your "result matrix". You are assuming that the results of the LSR and PHN trials are two completely independent events. They are far from that. The fact is the most likely outcome is that either both trials will be successful, or both trials will fail. There is therefore no way that the odds of "total failure" are only 25%. Heck if that were true, we would not even be close to having any discussions about a reverse split. The typical professional investor would jump all over a biotech with a 75% chance of a successful trial. I am afraid what we have is a plain old fashioned binary event. Either 144 works or it doesn't. I personally think the chances of a positive outcome are good. But they ain't 75%. No way no how.

      • 2 Replies to phakosurgeon
      • Yes, Napodano already weighted #2 (LSR positive / PHN negative) as a highly unlikely outcome, meaning that PHN has better odds (which we already knew), but everyone has to remember, Merck did quite a bit of clinical work with NMED160 earlier, so Neuromed/Zalicus already had insight going into both trials and part of that insight was high dose efficacy. Bioavailability has been increased 6 fold, reaching or exceeding the old high dose, so solubility is not an issue any more. For us, it most likely is a binary event, win or lose, but the actual odds are equal at this point, not with what Zalicus has in hand thank to Merck. I would hate to get into the data to try to find a subset of patients for which Z160 might work, suggesting its limited application in the clinic. But, then again, morphine does not work for everyone. What we need is a clean result for both trials with 30% pain reduction or better, but one win would be better than none.

        Sentiment: Strong Buy

      • True. And then there's the human element-- pain scale. Not an exact science, for sure.
        That sunk Synavive, which I suspect probably was a viable drug.

    • Built to win.
      3 possible positive outcomes if 30% or more pain reduction is achieved.
      Good odds.

      Sentiment: Strong Buy

    • Four possible outcomes.

      Sentiment: Strong Buy

    • what happens to pps in the event that #3 occurs...???

      • 1 Reply to fins_2012
      • LSR is definitely more challenging because of the variability associated with this indication, but Zalicus has done a good job with its enrolling criteria to help minimize this variability.

        PHN is a stable pain model, big pharma recognizes this and institutional investors follow their lead.

        If #3 occurs, the price will be $30 following a hypothetical 1-for-10 reverse split at 0.6 PPS.

        If #1 occurs, $20 PPS, no reverse split, then the sky is the limit.

        If #2 is positive, $20 PPS, no reverse split, sinking back toward $10PPS maybe even $9ish PPS because of the emphasis given to PHN as a clinical pain model.

        And #4, this goes without saying.

        Sentiment: Strong Buy

    • Don't they all have a 25% chance?...all things being equal?