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Zalicus Inc. Message Board

  • scistats scistats Sep 11, 2013 9:04 PM Flag

    Major news.

    Both Z160 trials did not complete enrollment simultaneously on September 3rd. This would be impossible because the primary completion dates of the trials have a two month spread, and the treatment durations are the same (6 weeks).

    The press release for both trials was September 3rd, but this is NOT the enrollment completion date for both trials. Otherwise the primary completion dates would be the same, and they are not.

    Read the Zalicus press release carefully:

    "CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 3, 2013-- Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has completed patient enrollment in two Phase 2 clinical studies of Z160 for chronic neuropathic pain indications including lumbosacral radiculopathy and postherpetic neuralgia."

    Why is this so critical?

    The Estimated Primary Completion Date for Postherpetic Neuralgia is December 2013. The Estimated Primary Completion Date for Lumbosacral Radiculopathy is October, 2013. Keep in mind that the treatment duration of both trials is 6 weeks. This means Lumbo finished enrollment sometime in August, but when in August?

    Lets look at the trial protocol: "This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks."

    If enrollment for Lumbo completed on August, 12th, the last patients would finish the trial on September 23th. Corrigan could release a bottom line primary completion date update, and if positive, maintain $1 for ten days before October 7th. Keep in mind Lumbo enrollment could have completed before August 12th.

    Zalicus must complete the reverse stock split no later than ten trading days prior to the "Compliance Date" in order to timely regain compliance. This means Zalicus must make a press release around Sept. 23rd to beat the October 7th deadline. It is a small trial and very possible.

    Sentiment: Strong Buy

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    • If Z160 pain control is so obvious, the trial may not need the whole 140 patients to reach statistical significance. In that case, Corrigan can release top of line result before Oct 7 to void R/S.

      Sentiment: Strong Buy

      • 3 Replies to wildbullus
      • WB,

        I hate to be one to introduce a bit of reality, but this thread unequivocally assumes the trial will be an overwhelming success because it focusses on obviating the R/S and not on the putative success of the trial.

        The reality of these types of trials is that the data is often all over the map because it is completely subjective; even a patient on Z-160 will have good days and bad days depending on their pain levels. This is not like analyzing quantifiable physiological parameters. The success of this trial is completely dependent on subjective responses from the patients. Second and more importantly, we may (this is conjecture on my part) find an exceedingly high level of drop outs in these PII trials. Not sure how this will/can be incorporated into data analysis. Imagine for a moment that you (or I for that matter) were on such a trial and in extensive pain, and you (I) received the placebo. How long would it take us to tell our doctors that the pain is bad enough that we want to be put back on the medication or treatment we were receiving before the trial began? Agreed, it may not work too well, but certainly it will be better than not receiving treatment at all. Six weeks of unabating pain is a lot to ask of a patient. Again, this is subjective because some have a high tolerance for pain and others much less.

        The rubber will meet the road if we can get to the PIII trial wherein Z-160 will in all likelihood be compared to the best and most current treatment(s) available to determine comparability. In that trial, the drop out rate will be much lower, but comparability will rule the day.

        Granted, all this is speculation on my part, but some on this thread expect this trial to be a slam dunk and my point is that I hope the untreated placebo group remains sufficiently populated to generate meaningful results when the trial has completed. If not, the data analysis will pose a bigger problem than is perceived and take longer than expected.

        JMHO,

      • Yes, but if enrollment of the Lumbo trial was completed on or before August 23rd, Dr. Corrigan could have all of the data analyzed and make an announcement on Oct 7th, 2013 morning.

        Was the first trial (lower back pain) enrollment completed on or before August 23rd? Well, they announced enrollment completion of BOTH trials on September, 3rd 2013, and the second trial is TWO MONTH behind the fist trial based on primary completion dates.

        Do the math. Trial #1 enrollment almost certainly completed enrollment on or before August 23rd. Dr. Corrigan will have the data in his hands on or before October 4th to analyze for the primary endpoint and make an announcement on October 7th morning for a stock pop above $1 that will hold through the October 21st deadline. This will avoid the RS and make us all very happy (if we meet the endpoint). The remaining data details will be subsequently published.

        The CRO Dr. Corrigan is working with is very efficient and can meet this tight deadline. Re-read the enrollment completion announcement for both trials and review the primary completion dates spreading the trials apart by two months. These trial did not complete enrollment simultaneously and trial #1 completed on or before August 23rd. This is good news.

        Sentiment: Strong Buy

      • Top-of-line results typically take at least 6 weeks to compile. They won't come before October 7, and it's not up to Corrigan to compile the data anyway. That's up to the independent research team.

    • I could be wrong, however I thought October 7th is the last day they need to break a dollar. I thought that was the date in which it needed to be $1.00 or more in order to have enough time to satisfy.

      Anyone?

      • 2 Replies to jakobi007
      • Jason Napodano's comment:
        The company has until October 21, 2013 to regain compliance with the NASDAQ minimum bid. To regain compliance, the stock has to close $1.00 per share for ten consecutive trading days. Therefore, for Zalicus to regain compliance, the stock has to close $1.00 for ten days on or before October 7, 2013. If they stock does not close $1.00 per share on or before October 7, 2013, the company WILL do a reverse split. Shareholders have authorized 1-to-5 and 1-to-10.

        I do not believe that Z160 data from either the LSR or PHN study will be out before October 7, 2013. Thus, unless there is other significant news that drives the stock $1.00, I think a reverse split is inevitable.

        Sentiment: Strong Buy

      • Zalicus must have 10 consecutive trading days at or above $1 before October 21st.
        To achieve this goal, they must start on October 7th and hold above $1 it through Friday October, 18th to meet the 21st deadline.

        BUT!
        Corrigan can forfeit the reverse split altogether!!!
        If the enrollment for the first trial completed on August 23rd, which it likely did, 6 weeks from this date is Friday, October 4th. They can announce the results on the 7th instead executing a reverse splint and have the good news break PPS above $1 instead of the 1:5 or 1:10 reverse split. Make sense?

        QUESTION IS: Did the first trial enrollment end on or before August 23rd...I bet it did because they announce the enrollment completion of both trials on Sept 3rd, and the second trial is two month behind the first. Make sense? In other words, high cotton. Corrigan announces bottom line results early and publishes the rest in the subsequent publication.

        Sentiment: Strong Buy

    • I still think a run up will occur as we get closer, as I am not expecting the data to save the R/S. However, I think I see where you are possibly going. Just because they announced on the 3rd they completed enrollment doesn't mean that recently happened. They could have completed enrollment weeks before.

      Is that what you are saying?

      I found this on Google from a news site earlier this year.

      "...These trials were initiated recently, although they are relatively short in length and should provide investors with results before the end of this year. According to estimates, we are looking at LSR data around August of this year, and PHN data most likely at the very end of the year."

      • 1 Reply to jakobi007
      • Yes, the evidence suggests that enrollment of the lumbosacral radiculopathy trial (first trial) completed well before Sept. 3rd. It probably completed in mid-August as your interesting find from the Google news site reports.

        If so, Zalicus can easily report this news on or before October 7th and avoid the reverse split with 10 consecutive days closing at or above $1. However, if the first study fails to meet its endpoint, they will go into a holding pattern to try to release mixed results, assuming the second trial meets its endpoint.

        Preliminary NMED160 Merck data suggests Zalicus will meet its endpoint with 30% or better reduction in pain. NMED160 is the old formulation with low bioavailability. GLTA. October, 7th is the date to watch for.

        Sentiment: Strong Buy

    • "It's the bow to the wow, creepin and crawlin...SCI DAUGGY DAUGG, bowwowwowyippyyoyippyay..."

    • You're wrong. The company opened up the number of sites for PHN in order to finish enrollment for that study around the same time as the LSR study. Jason Napodano pointed this out in an article back in early August.

    • l like it i love it i want some more of it.

    • If the final few enrollments were, by chance (50/50%), placebo and these patients drop out because of pain, this saves a few critical days.

      Sentiment: Strong Buy

    • So what? Why becoming crazy about that? you don't have the dates in your hand so what's your point?
      As usual you suppose...connects dots...etc. etc.

      You can't convince people to invest because some data is coming earlier maybe!

      Following what will happen with or without your supposition:
      1) Run up happen before data. No R/S.
      2) No run-up and R/S.
      2a) Results are bad and ZLCS collapse
      2b) Results are Good and pps go to the stars

      R/S is not a concern.
      Only results are but since you look so confident about them why worry yourself?

      Sentiment: Strong Buy

    • im holding

    • zlcs may do a run up w/o a press release. shareholders do not want an RS. investors anticipate data this year at some point, december at the latest. it may run up to avoid the RS, this happens quite a bit in biotech. it was .90 last week on...well, nothing.

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