Joe Springer's  Instablog

Joe Springer
  • on Retirement
Send Message
It is very hard or impossible to time the broad market consistently — there are no famous investors that got rich by consistently knowing what the broad market would do next. This only makes sense, as there are just too many variables in the broad market. But there are many famous investors who... More
My company:
My blog:
The Wall Street Exclusive
  • What Success Should Look Like For TNX-102 SL 32 comments
    Sep 2, 2014 5:44 AM | about stocks: TNXP

    Here's a linkfest of the trials for Tonix Pharmaceuticals' (NASDAQ:TNXP) TNX-102 and the three approved drugs in FM. The mean baseline of patient pain at the beginning of the trial is listed after each, the percentage of most intense pain that number represents is calculated to compare the trials to each other:

    • TNX-102 2a (2.2 on 0-6 scale with 6 most intense) 46%
    • BESTFIT
    • Lyrica (7 on 0-10 scale with 10 most intense) 73%
    • Lyrica 2 (7.1 on 0-10 scale with 10 most intense) 74%
    • Cymbalta (6.525 on 0-10 scale with 10 most intense) 68%
    • Cymbalta 2 (6.6 on 0-10 scale with 10 most intense) 69%
    • Cymbalta 3 (6.5 on 0-10 scale with 10 most intense) 68%
    • Savella (logarithmic scale and not provided)
    • Savella 2 (71.2 on 0-100 scale with 100 most intense) 71%

    Tonix' 2a trial was small, so the fact that it got statistical significance in pain, tenderness, and depression vs placebo is notable. It is also notable that the most important measure (pain) started from a not very elevated level in the first place.

    Have a look at the amount of improvements and the changes over time in the trials for the approved drugs. Lyrica, for example, was typical. Something like this should be what approval looks like for TNX-102 SL:

    (click to enlarge)

    Disclosure: The author is long TNXP.

    Stocks: TNXP
Back To Joe Springer's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (32)
Track new comments
  • Doewap
    , contributor
    Comments (1009) | Send Message
     
    Joe, thanks as always for your propensity to share.

     

    Is the bestfit data intentionally left out...?

     

    I have to ask about your profile picture, if you don't mind. Is that an insert of a picture of your (or just a) dog or is the dog sitting in front of a drawn blind and in that case, is that then the dog's pair of sunglasses on the table?
    2 Sep 2014, 06:11 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » You are most welcome Doewap, BESTFIT has not reported yet, I linked it so people could see the primary and secondary outcome measures.

     

    The pic - that's my pup, he's sitting next to me in front of a blind, it might look a little funny because I pulled him in slightly in photoshop so the pic would be more zoomed in.
    2 Sep 2014, 06:22 AM Reply Like
  • Doewap
    , contributor
    Comments (1009) | Send Message
     
    OK, to avoid looking stupid; I thought that this line

     

    The mean baseline of patient pain at the beginning of the trial(...)

     

    meant that for BESTFIT this metric is a known.

     

    I guess I need to learn more about trial processes.
    2 Sep 2014, 07:07 AM Reply Like
  • JKenser
    , contributor
    Comments (565) | Send Message
     
    Joe, might I add that not only was the 2a trial small, but it was also very short in duration. A longer trial with more restful nights of sleep I believe will equal better results, as you know from what we saw in the Sod. Oxy trial.
    2 Sep 2014, 09:21 AM Reply Like
  • CC1972
    , contributor
    Comments (66) | Send Message
     
    Where's the love for TNXP?
    2 Sep 2014, 03:03 PM Reply Like
  • DeeMmm
    , contributor
    Comments (43) | Send Message
     
    EXEL maybe gave everyone a dose of reality today? I have ZERO background on it and never even heard about it until it was on the news other than it was a biotech in 2nd or 3rd trial pretty much expecting good results I think? EXEL tanked today due to bad results.

     

    Any input, comparisons to that deal and TNXP that provides you any pause Joe?

     

    Hmmm, did me a little but am holding tight. Like a guy who wears a tux once a year, I'm slightly uncomfortable but willing to go through it to take the belle to the ball!
    2 Sep 2014, 05:17 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » I really don't think there is much crossover DeeMmm, biotechs report good and bad results all the time, EXEL was valued more than 10X Tonix and was going after prostate cancer.
    2 Sep 2014, 05:23 PM Reply Like
  • freegriff
    , contributor
    Comments (114) | Send Message
     
    Joe, the 2a, as you noted, starts from a less elevated pain level. I find it odd that the level is so different from the levels of the other drugs, which are all approx the same at upper 60s and 70s. Does that concern you at all with respect to the method in which they carry out the trials? I can imagine positives and negatives. Is this an anomaly of the small trial size? Would you expect the starting pain level to be more in the 70% range for BESTFIT? Just curious on your thoughts for what that may point to. Bad patient pop? Bad wording of question? Was the room too comfortable? lol I can imagine Pfizer turning the A/C waaaaaaaay down when they asked patients to rate their pain to make them extra uneasy at the start.
    3 Sep 2014, 05:24 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » Thank you for the q's willygriff:

     

    Yes I expect BESTFIT to be 60-70ish like the other trials, because of that I think they should get a bigger drop than in the 2a, albeit with some placebo drop as well.

     

    It may be an anomaly in the small trial size, but I think recruiting the trials may tilt toward finding ones in pain, they are the ones that should potentially need the product after all. The lead in the trial is the (literally) world renowned Dr. Daniel Clauw, he was one of the leads in the 71% Savella trial (and he's worked with all the approved companies in some capacity).

     

    Moldofsky's 2a study was more focused on sleep (he's a sleep guy) and had no pain focus other than as one of the symptoms tested.
    3 Sep 2014, 06:19 PM Reply Like
  • DeeMmm
    , contributor
    Comments (43) | Send Message
     
    http://bit.ly/1qgt5p9

     

    Thanks for the further clarification Joe. I looked up Dr. Clauw. Very impressive and his focus aligns with these drugs and tests very nicely!
    4 Sep 2014, 11:19 AM Reply Like
  • DeeMmm
    , contributor
    Comments (43) | Send Message
     
    http://1.usa.gov/1qgtxUv

     

    Abstract by Dr. Clauw.
    4 Sep 2014, 11:21 AM Reply Like
  • Steve Geary
    , contributor
    Comments (7) | Send Message
     
    Joe,

     

    I wanted to see if your price target has changed compared to what you laid out previously based on any new information or trading activity. Very excited for October.
    5 Sep 2014, 11:17 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » Short term price target: $100
    6 Sep 2014, 12:39 AM Reply Like
  • SaltyDog62
    , contributor
    Comments (835) | Send Message
     
    Nice. Hope so.
    6 Sep 2014, 12:43 AM Reply Like
  • SaltyDog62
    , contributor
    Comments (835) | Send Message
     
    I am surprised that the pps has not risen in line with your expectations. Any thoughts on that Joe? I am planning to buy more, in fact, bought more at 14.80 recently, initiated position at 11.
    6 Sep 2014, 01:17 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » I'm not sure I had any pre-data expectations, but we are basically in "any day" territory now..
    6 Sep 2014, 01:34 AM Reply Like
  • petethepanzer
    , contributor
    Comments (1055) | Send Message
     
    not happening but i think it does $40
    11 Sep 2014, 11:47 PM Reply Like
  • Doewap
    , contributor
    Comments (1009) | Send Message
     
    Seems results will be later than we as humble followers thought. Those with very short term focus are selling. An opportunity? Maybe, but I recently have had my share of biotech disappointments (Amarin, pSivida, AcelRX to name a few) and they all sold off just before the bad news hit. Now, don't get me wrong, I do believe Tonix is a different story (and btw, ACRX is not really a failure), but I am more cautious this time around...
    12 Sep 2014, 05:15 AM Reply Like
  • petethepanzer
    , contributor
    Comments (1055) | Send Message
     
    i think theres no chance of failure but a chance that it underperforms with only 30% increased response over placebo in sleep improvement
    6 Sep 2014, 12:35 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » 30% over placebo is grand slam territory, none of the approved drugs got near that, more like effect in the 20s with placebo in the 10s. Map (in migraines) did so well no further trials were required and they did not get 30% over placebo (58.7% vs 34.5%).
    6 Sep 2014, 01:11 PM Reply Like
  • sheldond
    , contributor
    Comments (1442) | Send Message
     
    Joe,

     

    I think we are good to go. I am not one to hold through the typical binary set up because I usually have no way to predict outcome. I do believe this is a unique opportunity and have a good amount of shares and it is a major part of my trade portfolio.

     

    I would be very surprised not to see approval but I have a plan if the unexpected happens. This is the final big play I had set up for this month. This has a chance to be my best year yet if this one works out like my last few trades have. Then again TNXP has already given me a lot so I am happy to wait. It won't let me retire either way although it would bring me farther up the mountain. Plus isn't the fun in the journey. Finding these types of stocks is the best...I look forward to our next 10 20 or 100 undervalued stocks. I'm sure you will be digging up the next idea soon enough.

     

    Did you say $100? Maybe I should just go all in? :) hmmmmm I wouldn't do something like that would I? The one time I tried that personally I barely got out before catastrophe so....I guess not but maybe I should. :) $ dont worry I have more discipline today.

     

    Thanks again Joe

     

    Best,

     

    D
    6 Sep 2014, 01:05 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » Discipline over conviction always my friend.
    6 Sep 2014, 02:20 PM Reply Like
  • sheldond
    , contributor
    Comments (1442) | Send Message
     
    Yes!

     

    That is the truth. By the time we hear news I will probably have cashed out most of my other stocks for this portfolio. It would take a horror story to ruin my month or year. I have just been sitting on these TNXP shares letting the thesis play out again. It seems to be a genre I enjoy. The art of doing nothing.

     

    I think I am still buzzing from my $MGT play I need to breathe relax and get back to center. Focus on the next play......and all other applicable trite sports analogies.

     

    Best,

     

    D
    6 Sep 2014, 02:52 PM Reply Like
  • joedct47
    , contributor
    Comments (9) | Send Message
     
    Joe,

     

    A few questions I think a lot of people might like to know:
    1. Will we know when the testing company actually gives the testing results to Tonix Pharmaceuticals? (Other than between 6-8 weeks after 8/4/14)
    2. Any guesses as to how long is Tonics Pharmaceuticals is likely to take to digest the data once they receive the testing report?
    3. How will Tonix Pharmaceuticals release the news of the testing results to the world? (Press release/posting on their web site I assume.) Is there a regulation as to how they have to do it?

     

    Tnx
    6 Sep 2014, 09:17 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » 1 & 2: Shortly after they receive data they will issue a press release and hold a conference call whatever the results - that is what I am going on, no real guess for exact timing

     

    3: They have to do it in a public-to-all manner, for example by filing it with the SEC (public for everyone to see), but if Dr. Lederman has a flare for the dramatic there's an outside chance he could announce at Wednesday's conference (it is live webcast).
    6 Sep 2014, 10:11 PM Reply Like
  • Robert K. Stuart
    , contributor
    Comments (164) | Send Message
     
    Hi Joe!

     

    There has been some speculation as to the Company's recent tweeting of the R&R conference - nearly everyday last week. Perhaps there will be data release? Do you feel any way about that?

     

    Also, any plans for an article to follow up on ADMP - w/ Castor's recent move into the Company, the shake-up of BOD etc.?

     

    Thanks as always for your hard work. BTW - football fan? Do you have a team?
    7 Sep 2014, 11:20 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » That is funny you say that, I did not know anyone was speculating about that but it caught my attention, a lot of tweeting about it, I think they just think the stock price should be higher and are trying to draw attention to his presentation, but with the timing of things it is possible that they anticipate the possibility that they would be able to release results then. Outside chance.

     

    No plans for a follow up article on ADMP although I am pleased with the recent developments.

     

    I'm from Eagle country, go Foles..
    7 Sep 2014, 01:48 PM Reply Like
  • pkojich
    , contributor
    Comment (1) | Send Message
     
    Is the expectation still that data from the BESTFIT trial will be released early Q4?
    9 Sep 2014, 10:57 AM Reply Like
  • freegriff
    , contributor
    Comments (114) | Send Message
     
    pkojich- yes, early Q4, a few weeks away. That has been affirmed multiple times in recent months and will likely be reiterated at R&R tomorrow.
    9 Sep 2014, 01:33 PM Reply Like
  • Genfit&Tonix
    , contributor
    Comments (96) | Send Message
     
    I think data will be released within 7-14 days..
    Can't wait, i think we will see 30+..
    And $100 after FDA approval..
    10 Sep 2014, 08:05 AM Reply Like
  • Genfit&Tonix
    , contributor
    Comments (96) | Send Message
     
    Can't wait! I think we will see 30+ this month..
    And $100 after FDA approval..
    10 Sep 2014, 08:09 AM Reply Like
  • Doewap
    , contributor
    Comments (1009) | Send Message
     
    Timing on the FDA approval? Joe once answered something like 3 to 6 months for a decision on a possible second phase 3 trial, then up to a year for the NDA? That would put us in Q2 2016 IF the second phase 3 is not needed... geez that is a long time...
    10 Sep 2014, 08:13 AM Reply Like
Full index of posts »
Latest Followers

StockTalks

  • $AMNF $3.8 million cash at end of Q1: http://tinyurl.com/gwdhpdf Should be able to fund expansion
    May 27, 2016
  • Look $MIK vs other brick&mortars http://goo.gl/0V4q8H Retail selloff is buy in Amazonprotected MIK 16.3 PE DivCatlyst Chttp://goo.gl/yiv2sM
    May 11, 2016
  • $ADMP Adamis License Agreement with Allergan plc Subsidiary for Epinephrine Pre-Filled Syringe http://goo.gl/u4gEU3 Carlo is a dealmaker
    May 10, 2016
More »

Latest Comments


Most Commented
  1. Fire Away ( Comments)
  2. I Am You See ( Comments)
  3. What Is Tonix Worth? ( Comments)
  4. Hooked On Tonix ( Comments)
  5. Seattle Super-Tonix ( Comments)
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.