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Zalicus AŞ Message Board

  • ranger43a ranger43a May 23, 2013 2:34 PM Flag

    Early Z160 LSR results?

    They said results are likely 3rd quarter 2103. Everyone assumes that results will be out around September.
    HOWEVER, the third quarter starts July 1st.
    I do not know the enrollment data, but this is only a 6 week trial.
    Who knows, results might come earlier than expected and side swipe us all... (in a good way, I hope)

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    • They will not announce results until trial is completed which is september 2013.

      Sentiment: Hold

    • Hey Ranger .. i say mid September we get the results.. the study is scheduled for completion in august

      now, i think Junior posted something about enrollment already being completed (not sure if it was junior or not)... anyways .. once enrollment is completed and updated on clinical traisl website, 6 weeks from that point forward will be pretty intense .. i think Z has the potential to fill the gap prior to any z160 news as mentioned in another article... assuming there's not a reverse split .. personally i dont think this will happen because just from emails ive received from renz he's stated many times that they are very excited about the data for z160

      LSR is a success, and im looking forward to that day :)

      just out of curiosity, with a positive LSR study what pps are ppl expecting? i told my brother 3 or higher but he thinks 2 at the most .. should be fun either way

      • 3 Replies to garrettklein87
      • Garrett, the Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy is based on the change in average daily pain score (PI-NRS). The higher the score, the more pain the patient is suffering. This is the primary outcome measure for the trial.

        Pfizer Global R&D says a 2 point reduction on this scale is clinically relevant/significant. On average, a reduction of approximately two points, or a reduction of approximately 30% ,in the PI-NRS represents a clinically important difference.

        The PPS is going to correlate with the reduction in PI-NRS. The more points reduced by Z160, the higher the PPS.

        The next time you communicate with Justin Renz, ask him what is their "cut-off for success" is. Is it a two point reduction as Pfizer defines success, or do they require 2 point reduction to declare victory? We do not know the answer to this critical question.

        Now, if they manage to get a 3 point reduction 30% with no side effects, the PPS does not go to 2 or 3, it goes to 10 PPS. The reasons are:

        1. No side effects.
        2. Effective.
        3. Potential to displace opioids for some indications.
        4. The phase 3 will be fast because this is a pain study and investors have to move quickly on this one as will companies who plan to buy Zalicus whether they like it or not.

        If you can get Renz to give a PI-NRS reduction that defines success, please post. I do not think that Z160 can achieve more than a 3 point reduction, which would be a success by Pfizer's definition.

        Sentiment: Strong Buy

      • The Z160 study is currently recruiting participants.

        Sentiment: Hold

      • I say a spike into the $2' or $3's then back to $2.
        Let's face it....a lot of people will want to unload some shares on a huge spike, as they have held big positions for a long time and are exhausted over this company. So that will bring us back to $2 probably.

    • I meant 2013...lol

 
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