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Joe Springer

 
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  • Tonix May Not Need Final Trial [View article]
    You are most welcome Genfit&Tonix, thank you.
    Aug 10 11:43 AM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    The point being that Levadex was all Map had, whereas BESTFIT represents the FM program but also bolsters the PTSD program, and tension headache may be their biggest of all.
    Aug 10 11:09 AM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Very low float michabreakstone, only 13 million shares total, half million bucks gets you 1/3 of 1% of this company at this price, so when buyers come in it has an effect, trial data is getting closer, and Tonix got slammed from July 7th, like the whole biotech field, it's not even back to that level yet.
    Aug 10 11:02 AM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Thank you AdamAnt8, that's a great question, patents are good for 20 years from filing in the US (the US is easily the biggest market and about 1/3 of the world).

    The FDA site is actually very good for understanding the review process:

    http://1.usa.gov/XIVgxq

    I have not read through the Investopedia biotech industry guide, but they generally have pretty good info:

    http://bit.ly/XaMZXL
    Aug 10 10:57 AM | 1 Like Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Both Map and Tonix were guided that they needed to do 2 trials, similar to each other and a little different from previous, it's a very similar situation.
    Aug 10 10:49 AM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Data absolutely matters, and I get it with D's explanation Genfit&Tonix, don't know about J&J but people slept on Celgene and Biogen Idec (Coke and Apple too)..
    Aug 9 10:29 PM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Savella is very similar to Cymbalta, they both are serotonin-norepinephrine reuptake inhibitors and they did about $100M and $600M in 2012.

    Lyrica is different (a membrane stabilizer) and did about $475M in 2012.

    TNX-102 SL is the only sleep medicine, and disturbed sleep is pervasive in FM (more than 90% complain of it).

    FM only started getting validating medical language as a real disease in the late 1980s, no drugs approved until 2007. The market is growing quickly and for those three and drugs prescribed off label it grew about 14% compounded annually from 2007 - 2012.

    At that rate Lyrica would be doing $1B in 2017 and Cymbalta would be doing $1.3B

    $1B in peak sales for TNX-102 SL is seeming low..
    Aug 9 07:55 PM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    You'll have to ask Jason Genfit&Tonix (short answer: he raised it), $30 million - they were unknown and just getting funded, not listed on a major exchange until the Summer.

    "Did everybody sleep beside you 2 J&J ?"

    While *I* understand you, could you ask the question another way so the class understands?
    Aug 9 06:11 PM | 1 Like Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Thank you for the questions blackwallst,

    "how is it that the peak sales for FM is twice the high end peak sales for MAP's drug?"

    More details below but one thing is TNX-102 SL is for chronic, every night use, whereas Levadex is for acute relief when you have a migraine.

    "Does TNXP have patents that will cover the drug long enough to reach 1B in sales?"

    They have current active patents and even better ones that have been applied for, they should have excellent patent protection and market exclusivity into the 2030s for both TNX-102 SL and TNX-201. Dr. Lederman at the Roth conference:
    "You only get twenty years from filing. So, we're focusing on patents that have been filed relatively recently. But, we're very confident that they will issue them. I've been an inventor on a number of issued patents, and a law firm, when they file patents, makes a representation that they think it's novel, and I think that it's pretty clear if you look at what we're doing in terms of the sublingual formulation, the eutectic - which is the composition of matter on cyclobenzaprine, and the pure isomer isometheptene, we're pretty comfortable that these are very novel, and they're certainly useful."
    They hired Ropes & Gray to file and defend the patents, that is the law firm that filed and defended similar protection for oxycontin for Purdue Pharmaceuticals, and those patents lasted until they expired naturally.
    There's more info on the patents in the latest presentation:
    http://bit.ly/1aJkAbG

    "Others have peak sales at about 200-300 mil"

    Who has 200-300? The only projection I've seen besides my own is from Jason Napodano who arrives at $600 million and calls it conservative - he uses the estimated few years ago off-label use of CBP in FM, he calculates 5% of oral CBP instead being sold as sublingual. If he had calculated a possibly still conservative 25% instead that's $3 billion.

    As of a couple years ago 2.4 million Americans with FM were being treated by doctors, less than half of the number of people with the disease. That number is growing in double digit percent as the disease is finally gaining acceptance.

    There is no approved sleep drug for FM, and more than 90% of FM patients complain of poor sleep quality.

    TNX-102 SL is as an every night medicine, and the other approved drugs for FM Lyrica and Cymbalta cost about $10 a day.

    $10 a day from each of those 2.4 million comes to $8.8 billion.

    If the market grows to 5 million patients that's $18.25 billion.

    Lyrica and cymbalta are on pace to do $1 billion themselves, I really think $1 billion in peak sales is a conservative number for TNX-102 SL in FM.
    Aug 9 04:28 PM | Likes Like |Link to Comment
  • Attention David Jackson [View instapost]
    Thank you David!
    Aug 9 02:35 PM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Map and Puma were straight lines, good results will be big. BESTFIT's implications for the AtEase trial in PTSD, and the possibility of no final phase 3 trial could take it higher. Also I think tension headache will start to become valued as more managers look at the stock, very big market:

    92 million adults in the U.S. experience tension-type headaches

    Constant band of pressure on the back/sides of head; “squeezed in a vice” feeling

    Projected that 34 million experience frequent episodes, 12 million seek a medical consult

    http://bit.ly/1aJkAbG
    Aug 9 01:38 PM | 1 Like Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    The day after? I will say $1 billion.
    Aug 9 11:46 AM | Likes Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    Hi hatvani, thank you for the question,

    A few things to consider for BESTFIT:

    -The 2a trial showed statistically significant improvement in pain, and that's all BESTFIT has to do. In the "10 things" article I talk about the reasons this BESTFIT could be expected to outperform the 2a trial.
    http://bit.ly/1v6ynqV

    -They used a well known and already approved eutectic to make the sublingual version, and it performed as expected in pharmacokinetic trials.

    -CBP has been approved in other conditions for a long time, and has an excellent safety profile, and this is a very low dose of CBP.

    Every trial has risk, but I think the probability of success looks very good.
    Aug 9 11:37 AM | 1 Like Like |Link to Comment
  • More on Tonix Pharma Q2 results [View news story]
    There is no news here at all, it's all good and expected. More on Tonix: http://seekingalpha.co...
    Aug 9 09:31 AM | 1 Like Like |Link to Comment
  • Tonix May Not Need Final Trial [View article]
    "there is not alot of data for this drug "

    Cyclobenzaprine has been on the market since it was approved in 1977, and at doses more than 10 times TNX-102 SL. Its safety profile is excellent. How many drugs that have ever come up for approval already had 4 decades of safe use?
    Aug 8 11:30 PM | 4 Likes Like |Link to Comment
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