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Zalicus AŞ Message Board

  • scistats scistats Sep 27, 2013 11:55 PM Flag

    FDA Orphan Approval Status: Not FDA Approved (yet) for Orphan Indication...the rest of the story.

    The rest of the story.

    So what is the real news of the day?

    Well, it has to do with the LSR study completion. A while back, somebody wrote that, "With 99% confidence, Zalicus will complete enrollment of their LSR study, with final top line data in the box on or before September 25th, 2013".

    Then, one September 26th, this happens: "Not FDA Approved (yet) for Orphan Indication"

    Then Zalicus issued a news release and SEC filing on September 27th.

    Now do you really believe we achieved the largest volume in Zalicus histroy based on an orphan indication that is not yet approved? Really?

    I did not think so! You are smarter than this!

    No, we had buying because the LSR data is in. Orphan status (not yet approved) was just cover news.

    Ladies and gentlemen, we have an answer. Something smells positive. Now there are not enough days left to secure a PPS above $1, its to risky to risk a slip below a dollar and risk breaking the "consecutive" requirement. What we can expect is clinical trial results.

    Sentiment: Strong Buy

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    • Your posts are impressive , but I think I figured out what's been lacking. .
      Like Abbot without Costello or Laurel without Hardy , it's a shame Stockdaug's SA debacle has left you flying solo.

    • rosettawest Sep 28, 2013 11:49 AM Flag

      I've been in ZLCS for a while now, but haven't paid much attention to the message board politics. I took note of this post though, and all the abuse it attracted, and I don't understand why. Given the timing laid out by the poster, it seems entirely plausible that some kind of news has leaked out now that some data is in hand. Sure we also got the orphan designation, but 23 million in volume???
      I don't think an announcement is imminent, like the poster, but I wouldn't rule out a leak.
      Anyway, I'm hoping for the best. I've done well with my investments this year - a couple doubles, and maybe a triple with ACAD - but I have yet to get in on the ground floor with a real monster stock. I think this could be the one. Good luck to everyone.

    • DAUG,,,you can move on..this isnt the little retailer coming in
      z160?? haw $100

    • LOL
      Thx for all the time you make me laugh with your posts.

      Sentiment: Strong Buy

    • "Now do you really believe we achieved the largest volume in Zalicus histroy based on an orphan indication that is not yet approved? Really?"

      Absolutely...most the posts on this board show that investors don't know the difference. While I agree with you that it should not have moved the stock price or at best caused it to return to .76 from which it started on Friday, the Orphan Disease Status was clearly the moving factor. Case in point, your argument i.e., "Well, it has to do with the LSR study completion" suffers from the same criticism; namely, "Not FDA Approved (yet) for LSR..." How does this differ from "Not FDA Approved (yet) for Orphan Indication"? Further, your argument that " has to do with the LSR study completion..." is conjectur at best with no ounce of fact to support it just connecting the dots to come up with a pseudoconclusion. Whether or not the stock movement is logical, it was nonetheless was based upon the announcement of ODS. Don't complicate this more than it already is ( at least for many investors...present company excluded).


    • iamvinnyp Sep 28, 2013 12:10 AM Flag

      Question for you (without arguing any of the things you mentioned above):

      What will you be posting on Oct 8th (if the PPS has stayed above $1 from Sep 30th through Oct 7th), but no news on the trials are announced?

      a) Mgt is covering bad results because you expected results on Oct 7th and did not come
      b) Mgt wants reverse split and hiding good/bad results because of this

      I have seen this scene before where you have created an expectation that is constantly pumped, but remains unfulfilled and then mgt is bad because they failed to meet your expectation

      Finally, what are you trying to influence through your post above? I am just curious (because if people buy based on your expectation of news, wouldnt they dump when no news is forthcoming)

      Sentiment: Hold

      • 1 Reply to iamvinnyp
      • No one is pumping anything, just putting forth a case and arguing it with facts. I previously calculated that September 25th was, with a great degree of confidence, when the final LSR data would be in hand at Zalicus headquarters. Because of this, I think trial news will be released soon. I have not thought beyond this nor have devised some 'great machination' to stage October 7th in a elaborate scheme of witchcraft and voodoo. I simply think on or before this date, we will likely get trial news. I prefer to avoid a R/S, but it is mathematically neutral, so it is difficult to argue that this is bad or good and the same goes for the trial results if they are released after this date. But the real point is that Sept 27th was entirely unusual for something that has not really happened yet, and by this I mean Z160 has not yet proven to work for PHN nor has the FDA approved it for orphan indication. Sort of a non-event. So, we can overlook this stark reality or ask some questions without pointing fingers at the messengers. Which makes me think you are, by your statements, encouraging people to buy on no news and continue to do so until there is. Probably it is best to simply drops the accusations and finger pointing and stick to debate lest one get the wrong impression of you. After all, if I am long, which I am, I would never sell until my shares rest warmly in the bosom of a big pharma.

        Sentiment: Strong Buy