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  • Tonix Is A Buy On Endpoint Circumstances [View article]
    B.ogden,

    1) Yes but they have a lot on their plate at the moment, they are likely staring down the barrel of beginning clinical trials in FM, PTSD, and TH (different drug of course). So the other very enticing indications for sleep quality will be turned to only after they take care of all their other activities, but if things progress well I would not be surprised to hear that they are expanding just like they expanded into PTSD.

    2) Actually not, it's a change in CAPS score between TNX-102 SL 2.8 mg and placebo, CAPS is an inventory of overall PTSD symptoms:

    http://1.usa.gov/1wVfXqg
    Sep 30, 2014. 03:36 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I think we will hear that they are on the track they have been saying all along, they need one more pivotal trial and no change to previous timeline. That has TNX-102 SL on market in 2017.

    But it is STILL not the fourth quarter (not a sports metaphor), results came in ahead of time, so they are officially ahead of schedule if they are told one more pivotal.

    I'd guess BETTERFIT enrolls late Q1..
    Sep 30, 2014. 03:19 PM | 2 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    That is true, but with the new PDUFA laws every 5 years the FDA has been raising fees in return for speedier and more accountable turn-arounds, the rule is 75 days, I think they can break it without consequence but it should be soon enough.
    Sep 30, 2014. 03:14 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Thank you for an apropos question neuralnetworks, I was quite pleased that after they filed their S-3 they did not issue shares before results, as some feared.

    I am convinced that: Everything depends on the outcome of the FDA meeting

    I don't think they'll dream of issuing shares when they are being valued at "FAIL" but should be revalued at "SUCCESS." So they wait on the FDA meeting, and then proceed from their.

    Guess what? There is no question this drug is helpful in FM. It also has an excellent chance to continue to show itself as remarkably safe. And the FDA is explicit that they are trying to help FM drugs to market. I think all option are on the table.

    Here is my prediction: They had to run 2 well controlled studies originally per the FDA, BESTFIT is deemed successful, they have to run 1 more, circa 4X the size of BESTFIT.

    That should cost circa 4X BESTFIT, an amount that they possibly could technically write a check for but would leave them destitute enough to have to raise money anyway.

    So I think they will report that, as they had planned all along, they have to do one more trial. That should be good to take them to new highs, and they should have no problem raising $50 million privately, which I think they will do.
    Sep 30, 2014. 03:09 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Most importantly the FDA should say with 75 days if they are on track, and I think they will get the news they want, and then where the stock is right now won't matter so much.
    Sep 30, 2014. 02:40 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I could be wrong about Roth and I don't mean to be flip, I did not like their tone since their last update and $17 price target, they sounded like jilted lovers to me.
    Sep 30, 2014. 02:34 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Thank you WolfnOne, I think that is the right thing to do here, they really got labeled as "Fail" but they could hear from the FDA that they got everything they needed to get out of the trial.
    Sep 30, 2014. 02:32 PM | 3 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Pain was measured daily about the last 24 hours...at least that is how most studies and the previous studies were done, they should present these results at a conference and submit to a journal (Rheumatology on both counts) and we will see all the details.
    Sep 30, 2014. 02:25 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Larger and the 30% responder analysis as the primary endpoint is what I'm thinking, but we'll have to wait to hear what FDA says..
    Sep 30, 2014. 02:23 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Cruel my booty - they are about to hear good news from the FDA (imo) and can be had at half price. Cruel...or beautiful?
    Sep 30, 2014. 02:19 PM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I don't think it will take very long in such a widespread condition, there is no reason that they are not on track and on time, and I expect that is what they will report from FDA.
    Sep 30, 2014. 02:17 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    You are most welcome 14195192, they really got everything they wanted, statistically significant improvement in pain, arbitrary that mean change was the primary, FDA already has precedence in 30% responders.

    Roth's reputation is, uh, not up to par with the rest of Tonix's people and associated companies, they helped Tonix raise money in the past, but I think Tonix outgrew them, is not engaging them for further services, and Roth does not want to make Tonix look good.

    As CEO said they should be meeting with the FDA within 75 days and they will try to make it sooner, I expect they will soon announce that they will run one more pivotal trial, larger than this one, and they will be on their way to the market on time.
    Sep 30, 2014. 02:13 PM | 2 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    Just wanted note the end of my last article on Tonix:

    "On good BESTFIT data, meaning good and anticipated safety data, statistical significance in pain, and general overall improvement for patients, Tonix should be a very valuable company, in the neighborhood of $1.33 billion market cap, or $100 per share."

    They got all that, the headlines yesterday all said "FAIL" and yes in capitals, but I think, this data will come to be viewed by the market in a different light, most especially after the FDA meeting, I think the FDA will look at this data very favorably.
    Sep 30, 2014. 01:44 PM | 9 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    It was comically tragically hilariously bad luck, a slightly larger trial (Savella's had 888 people to BESTFIT's 205) or any different pain primary endpoint...

    ..but I don't think it will matter, I think they will get good news in their FDA meeting and proceed with their effective and safe medicine.
    Sep 30, 2014. 01:37 PM | 4 Likes Like |Link to Comment
  • Unique Tonix Could Go Higher On BESTFIT Data [View article]
    I just submitted mine, I asked them to hurry it along - buy the dip!
    Sep 29, 2014. 01:25 PM | 1 Like Like |Link to Comment
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