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Joe Springer  

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  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Maybe you consider a small position, small enough where you don't have to worry much and it is easier to stay long, this stock has enough upside where if you ride it out a small position could end up being better than it seems now.
    Oct 1, 2014. 01:11 AM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Like he said:

    "We plan to meet with the Food and Drug Administration to review the BESTFIT data and to design an acceptable Phase 3 program...This is a drug that is active in many different symptom domains in fibromyalgia. We believe that there will be a path forward that will allow us to make this drug available to people with fibromyalgia."
    Oct 1, 2014. 12:37 AM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Primary endpoint was the mean, values were calculated both ways, in the graphic in the article it you can see both values.
    Oct 1, 2014. 12:26 AM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    All three measures that got statistical significance in pain got it with the strictest measure, counting drop-outs as non-positive events.
    Sep 30, 2014. 11:02 PM | 2 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    That is a subtle difference s19104, certainly would seem to follow that the ones that self reported the 30% or more improvement would also report much improved, but that is a subtle difference.
    Sep 30, 2014. 10:38 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Dale and Jeff I submitted a change and linked to your conversation, thank you.
    Sep 30, 2014. 10:37 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I'm thinking $25 - $30 million.
    Sep 30, 2014. 10:20 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    On second thought your explanation and the insights from it are better than excellent, really terrific point about one number in one endpoint only showing so much, and that together they are a compelling body of evidence in pain. Thank you.
    Sep 30, 2014. 10:11 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Dr. Eiseman I look forward to your article, I hope everyone reads it. I hope you found the explanation of what .05 means in the "Unique" article more spot on than this one. I used the rough cliff notes because I wanted to get to the point of the news in this one - thank you very much for your excellent explanation.

    s19104 very good points, I think 30% responder as the primary and 4X or so the size should leave little doubt.
    Sep 30, 2014. 09:59 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    1) I don't think they will use co-primary endpoints. If the FDA says to that's all the better, but the 30% responder analysis as the primary endpoint and a trial about 4X the size should do it without much doubt.

    2) They included it as a secondary endpoint for a reason. They had to pick one. In the Q&A of yesterday's call he said if they had known then it is likely they would have used it. It did not sound at all like it was thrust upon them by the FDA. The most recent approval in FM from the FDA was with 30% responder analysis.
    Sep 30, 2014. 09:40 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    "Held no later than 75 days"

    http://1.usa.gov/1wVZour
    Sep 30, 2014. 08:32 PM | 2 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I have not heard that one specifically discussed, but it could certainly be an interesting possibility.
    Sep 30, 2014. 08:30 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    "How is it more significant than the other measures?"

    I don't think it is more significant in FM than 30% responders, both are the basis for approvals.

    Clinical trials have primary and secondary endpoints, and the one they chose - mean average - just happened to not be as flattering as anything else that happened in the study.

    But in the call he was clear that had they known, they would have used 30% responders and gave no indication there would be a problem with doing that.

    "am I correct that this measure takes into account drop outs from the trial as essentially 0's"

    Yes, all 3 measures of pain that got statistical significance got it with the most conservative statistical method of counting the drop outs as non-positive outcomes (jump-to-control, multiple imputation analysis).

    "With 14% in the active arm not completing, that could significantly skew the results, correct?"

    Absolutely, the fact that all 3 still showed statistical significance (and with strong p values) when assuming non-effective results for 14% is very strong data in pain.

    Great points all.
    Sep 30, 2014. 08:18 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Needed some long hair for that to be a haircut, but the rogaine of the FDA meeting should be within 74 days.
    Sep 30, 2014. 07:53 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    "Mean average" was what the first 2 approved used, I think it was just used as a default, 30% responders is obviously acceptable to FDA.

    Yes they can do co-primary endpoints if the FDA says go ahead, that would give them a near guaranteed primary endpoint, but I don't think they have to, I think a larger trial on 30% responder analysis will be viewed as plenty sufficient.
    Sep 30, 2014. 06:42 PM | Likes Like |Link to Comment
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