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1. [verwijderd] 25 juni 2014 22:21

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   Tonix Approaching 100 Days Until BESTFIT Results
   Jun. 19, 2014 7:29 PM ET | 103 comments | About: Tonix Pharmaceuticals Holding Corp. (TNXP)
   
   BESTFIT trial results are about 100 days away.
   TNX-102 SL is poised to be the first line therapy in fibromyalgia.
   We expect favorable results from BESTFIT, and think the stock will approach $1 billion in market cap.
   On Thursday morning we spoke with Tonix Pharmaceuticals' (TNXP) CFO Dr. Leland Gershell. Let's get an update on Tonix.
   
   We picked Tonix as our top stock pick for 2014, you may recall, and the pivotal trial data that we think will send the stock much higher is approaching. On May 12, Tonix announced that it completed enrollment in the TNX-102 SL BESTFIT trial for fibromyalgia.
   
   FM is a debilitating disease that lacks good treatments. FM patients do not get adequate restorative sleep, even if they sleep all night, and have associated body-wide pain, tenderness, depression, anxiety, forgetfulness, decreased alertness, and fatigue. This is similar to what happens to every person that does not get adequate restorative sleep.
   
   FM takes over patients' lives, and FM patients are high-treatment seekers as a result. Most FM patients are on 2-4 drugs and still seeking relief.
   
   Most FM patients (64%) try the muscle relaxer cyclobenzaprine to improve sleep quality, and most (58%) find it helpful. The problem, however, is that CBP taken orally comes on and wears off much too slowly.
   
   There is a first pass mechanism in the liver that delays the oral form of CBP from becoming active for 2-3 hours, and also makes it last too long. This results in next day grogginess, from a medicine that was supposed to treat next day grogginess, amongst other things.
   
   That was the impetus for creating TNX-102 SL, a very low dose of cyclobenzaprine delivered sublingually, so that it takes effect almost right away and can peak and wear off in time for a restorative night's sleep.
   
   We believe that TNX-102 SL will be the first-line treatment for FM, and make Tonix a very valuable company. How valuable?
   
   A Billion-Dollar Company
   
   The other treatments for FM do a poor job and have side effects - best selling Cymbalta is just as likely to harm as help. Yet sales in FM for the approved drugs Cymbalta and Lyrica are about half a billion a year in the US ($560M and $450M in 2011). They are both also on pace to hit $1 billion in sales by 2020. They are coming off patent so they will not hit that number, but FM only had its first drug approved in 2007, after centuries of disease denial by the medical community. There is a lot of growth built in to the FM market.
   
   Biotech companies generally trade at a multiple of sales. For example, AstraZeneca (AZN) has a pretty low multiple and trades at less than 4 times annual sales, while Celgene (CELG) has a pretty high multiple and trades for nearly 10 times annual sales.
   
   Even if TNX-102 SL only equals the sub-par competition, it would eclipse a billion dollars in annual FM sales in the US. That makes Tonix a multi-billion dollar company, with a price per share in the hundreds.
   
   So why is the share price so low now?
   
   The only double-blind, placebo-controlled, multi-site clinical trial that Tonix has completed was a phase 2a trial with oral CBP.
   
   Now, with the upcoming announcement of the BESTFIT data, we will see if the sublingual formulation predicts that billion dollar sales path.
   
   The trial with oral CBP was meant to be a proof of concept study, but it actually showed statistical significance in pain reduction even in a sample one-fifth the size of BESTFIT.
   
   That is what TNX-102 SL needs to do as well for approval from the FDA - it needs to show statistical significance in pain reduction in two trials (BESTFIT followed by a virtually identical trial).
   
   Will the BESTFIT trial be a success? We are convinced the answer is yes for three main reasons:
   
   Safety: sublingual delivery of CBP is more effective than oral delivery, so a lower dose needs to be used, and a lower dose of a drug is generally considered a safety benefit. Even if that were not the case, CBP has been approved (not for FM) and on the market for decades in doses more than ten times that of TNX-102 SL, and has an excellent safety profile. Safety is usually a major concern in clinical trials, but there is almost no chance that there will be some unforeseen safety issue with this very low dose of a very well known drug.
   Longer duration: BESTFIT is 4 weeks longer than the phase 2a trial was. The extra time of restorative sleep should continue to help improve FM patients' symptoms. As we will see, this could also be important for TNX-102 SL's label.
   Larger sample: BESTFIT is powered with a large sample of patients to show statistically significant results if there is in fact a signal in the data. The 2a trial had only 18 patients in each arm, but the signal was still strong enough to show statistically significant improvement in three of five symptoms measured - pain, tenderness, and HAD (Hospital Anxiety and Depression) Depression. The 2a trial's signal was strong, now with a sample more than five times larger, and with the more effective delivery and longer trial duration, results should be even better in the BESTFIT trial.
   Label
   
   For approval, TNX-102 SL needs to show statistically significant improvement in pain in 2 trials designed like BESTFIT, with no need for Tonix to meet with the FDA before application submission.
   
   With success in BESTFIT, Tonix will run the final 12-week trial which should be nearly identical to BESTFIT, but could also contain small tweaks to build on the results of BESTFIT.
   
   We saw that the 2a trial showed statistically significant improvement in tenderness and depression in addition to pain, and while this will have no impact on approval, it could mean more favorable language on TNX-102 SL's label.
   
   100 Days
   
   Tonix announced complete enrollment in BESTFIT on May 12. 12 weeks later is August 4. The trial data is being managed by contract research organization Premier Research International. After the trial is complete, Premiere will take 6-8 weeks to compile and deliver the unblinded data. Eight weeks from August 4 is Sept 29, a couple days before the fourth quarter begins, and Tonix management has said several times they will release the top line data in "early" Q4.
   
   Dr. Gershell gave us some color on this. Tonix will issue a press release and hold a conference call to discuss the data, no matter what the case.
   
   If the data is good, Tonix will also likely submit a proposal to present the full results at the annual meeting of the American College of Rheumatology in mid-November in Boston.
   
   By that time we expect Tonix to trade at or near our post-BESTFIT price target of $61.53. We should find out top line results in about 104 days or so. The countdown is on.
2. [verwijderd] 25 juni 2014 23:20

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   Tonix Pharmaceuticals Receives IND Clearance From U.S. Food and Drug Administration for TNX-102 SL in Post-Traumatic Stress Disorder
   
   ir.stockpr.com/tonixpharma/press-rele...
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   Phase 2 Clinical Trial Expected to Begin in the Third Quarter of 2014
   
   NEW YORK, June 10, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, for the treatment of post-traumatic stress disorder (PTSD). PTSD is a serious mental illness triggered by a traumatic event and is believed to affect more than eight million U.S. adults. Under this IND, Tonix will be able to move forward in the third quarter of this year with its planned U.S.-based Phase 2 clinical trial designed to evaluate the safety and efficacy of TNX-102 SL in patients with PTSD.
   
   "The clearance of this IND represents an important milestone for Tonix and for the estimated eight million U.S. adults with PTSD, a serious illness with unmet needs and limited treatment options," stated Seth Lederman, M.D., Chairman and Chief Executive Officer of Tonix. "As with our IND of TNX-102 SL for fibromyalgia, our goal is to develop a new approach to a common central nervous system disorder with the potential to alter treatment paradigms. We are very excited about investigating the safety and efficacy of TNX-102 SL in PTSD while our potential pivotal study in fibromyalgia, the BESTFIT trial, has completed enrollment with top-line results available later this year."
   
   The planned randomized, double-blind, placebo-controlled Phase 2 clinical trial (TNX-CY-P201) will investigate the safety and efficacy of two doses of TNX-102 SL and placebo administered once daily at bedtime. This 12-week study is expected to enroll approximately 220 patients with military-related PTSD at about 30 sites in the U.S. The primary efficacy analysis will compare differences in mean scores on the Clinician-Administered PTSD Scale (CAPS).
   
   About Post-Traumatic Stress Disorder
   
   PTSD is a type of anxiety disorder believed to affect approximately eight million people in the U.S., and is a common problem among veterans, first-responders and other military-related personnel. PTSD can develop from witnessing or experiencing traumatic events, and is linked to suicide and to impulsive violent behavior.
   
   About Tonix Pharmaceuticals Holding Corp.
   
   Tonix develops first-in-class medicines for common disorders of the central nervous system. Fibromyalgia, post-traumatic stress disorder, and episodic tension-type headache are characterized by inadequate treatment options, dissatisfaction among patients and physicians, and significant economic impact. Tonix is currently conducting the first anticipated pivotal trial of TNX-102 SL in fibromyalgia, the BESTFIT trial (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy). Tonix expects to begin a Phase 2 trial of TNX-102 SL in PTSD in the third quarter of 2014. Tonix designed TNX-102 SL to decrease pain in fibromyalgia and in PTSD by improving sleep quality. Tonix's second clinical stage investigational new drug, TNX-201, is in development for episodic tension-type headache, and Tonix expects to begin clinical studies of TNX-201 in the fourth quarter of 2014. To learn more, please visit www.tonixpharma.com.
   
   Forward-Looking Statements
   
   Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K filed with the SEC on March 28, 2014 and future periodic reports filed with the Securities and Exchange Commission. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
   
   CONTACT: Tonix Pharmaceuticals Holding Corp.
   Leland Gershell
   Chief Financial Officer
   (212) 980-9155 x104
   leland.gershell@tonixpharma.com
   
   Public Relations:
   Dian Griesel Int'l.
   Susan Forman/Laura Radocaj
   (212) 825-3210
   sforman@dgicomm.com
   lradocaj@dgicomm.com
   Source: Tonix Pharmaceuticals Holding Corp.
   Released June 10, 2014
3. [verwijderd] 26 juni 2014 15:07

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   Tonix Pharmaceuticals Appoints Ronald R. Notvest, Ph.D. as Senior Vice President of Commercial Planning and Development
   By GlobeNewswire, June 26, 2014, 08:30:00 AM EDT
   Vote up AAA
   
   NEW YORK, June 26, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company focused on common disorders of the central nervous system, has appointed Ronald R. Notvest, Ph.D. to its newly created position of Senior Vice President, Commercial Planning and Development.
   
   Dr. Notvest joins Tonix from Evidec, where he applied his expertise in the commercial assessment and analysis of drug products on behalf of a variety of biopharmaceutical industry clients since founding the firm in 2002. From 1992 to 2002, Dr. Notvest held several commercial management positions at Wyeth-Ayerst Pharmaceuticals, including Senior Product Manager of Specialty Products Marketing, where he launched and marketed Rapamune® as well as prepared for the launch of Verdia®. As Associate Director for New Products Marketing, he was responsible for the commercial strategy of a portfolio of pharmaceutical products targeting central nervous system, asthma, immunology, cardiovascular, metabolic and endocrine disorders. Prior to 1992, Dr. Notvest held various scientific and management positions at Wyeth-Ayerst Research, including Section Head with responsibility for managing the drug discovery program for excitatory amino acids. Dr. Notvest earned a B.A. in biology from the University of Delaware as well as a Ph.D. in physiology and an M.B.A. in finance from Rutgers University.
   
   Dr. Notvest said, "As the pharmaceutical reimbursement landscape continues to evolve, I believe it essential to conduct market research, analysis and planning in tandem with drug development. I look forward to working with the Tonix team to develop commercial strategies for its candidates with the goal of optimizing their value."
   
   Seth Lederman, M.D., Chairman and Chief Executive Officer of Tonix, commented, "With a background that combines elements of science and business within the pharmaceutical context, Ron brings a unique set of analytical skills and marketing insights to our company, and we are pleased to have him join Tonix to direct our commercial planning and development activities. Whether we commercialize our prospective products directly or through partners, we expect that Ron's strategic perspective will better position our pharmaceutical assets to broadly address undertreated disorders."
   
   Read more: www.nasdaq.com/press-release/tonix-ph...
4. [verwijderd] 9 juli 2014 17:54

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   Tonix Pharmaceuticals Joins Russell Microcap Index
   By GlobeNewswire, June 30, 2014, 12:00:00 PM EDT
   Vote up AAA
   
   NEW YORK, June 30, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company focused on common disorders of the central nervous system, was added to the Russell Microcap® Index on June 27, 2014. A listing of all members can be found at www.russell.com.
   
   Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. The Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. As of December 31, 2013, approximately $5.2 trillion in assets were benchmarked to Russell Indexes.
   
   Read more: www.nasdaq.com/press-release/tonix-ph...
5. [verwijderd] 9 juli 2014 18:33

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   Tonix investor presentation July 2014
   
   content.stockpr.com/tonixpharma/media...
   
   (indrukwekkend)
6. [verwijderd] 11 juli 2014 14:35

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   Tonix Pharmaceuticals Announces Registered Direct Offering of $7.8 Million
   By GlobeNewswire, July 11, 2014, 08:20:00 AM EDT
   Vote up AAA
   
   NEW YORK, July 11, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company focused on common disorders of the central nervous system, today announced it has agreed to sell 657,000 shares of common stock in a registered direct offering at a price of $11.90 per share for aggregate gross proceeds of approximately $7.8 million, before deduction of placement agent fees and offering expenses payable by the Company. The closing of the offering is expected to take place on or about July 16, 2014, subject to the satisfaction of customary closing conditions. The shares are being purchased by new and existing institutional investors.
   
   Roth Capital Partners acted as the exclusive placement agent for the offering.
   
   Tonix expects to use the net proceeds of the offering to support the continued development of TNX-102 SL for the treatment of fibromyalgia, to initiate clinical trials of TNX-102 SL for the treatment of post-traumatic stress disorder, to initiate clinical trials of TNX-201 for episodic tension-type headache, and further develop our other pipeline programs, and for working capital and other general corporate purposes, and possibly acquisitions of other companies, products or technologies, though no such acquisitions are currently contemplated.
   
   The securities described above are being offered by Tonix pursuant to a shelf registration statement (File No. 333-192541) previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.
   
   This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus supplement, when filed with the SEC, and accompanying base prospectus relating to this offering may be obtained from Roth Capital Partners, 888 San Clemente, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC's website, www.sec.gov.
   
   Read more: www.nasdaq.com/press-release/tonix-ph...
7. [verwijderd] 11 juli 2014 19:11

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   Up, we gaan hier verder.
   
   Ik heb geen idee waarom men juist nu een capital raise doet, maar er kan een onverwachte kostenpost zijn gekomen of een investeerder die er perse in wil en waarin men een belang stelt om die aan boord te hebben.
   
   Het kan vanalles zijn. Het kan ook zijn dat er bij goedkeur een bonus aan het management uitgekeerd moet worden, weet ik veel.
   
   Liever nu dan later.
8. [verwijderd] 11 juli 2014 19:57

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   Nu zie ik het, deze heb je in de Koffiekamer aangemaakt, in plaats van onder Biopharma of Amerikaanse Aandelen.
9. [verwijderd] 11 juli 2014 20:32

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   Het is vaak een monoloog zo een draadje, en bij Biopharma en Amerikaanse aandelen zie ik eigenlijk nog minder volk die fundamenteel beleggen.
   En dit is voor mij toch een MT-LT belegging.
   BTW als ik een aandeel interessant genoeg vind voor IEX bekijk ik eerst of het bestaat, het maakt mij eigenlijk niet uit onder welke noemer het genoteerd staat.
   Maar ik zal me voortaan houden aan de ongeschreven wetten en regels van een forum ;)
   
   Overigens wel goed te lezen dat werknemers de aandelen minimaal aanhouden tot na de BESTFIT resultaten.
   
10. [verwijderd] 12 juli 2014 13:54

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    PTSD trial begint al dit kwartaal, het lijkt mij eveneens een teken van vertrouwen in TNX102SL.
    Het zou natuurlijk ook nog kunnen dat ze een kleine overname op het oog hebben ten behoeve van de pijplijn.
    Ze zullen niet voor niks een aandelen uitgeven na dat al recent te hebben gedaan, terwijl ze al een hele mooie stroppen pot hebben.
11. Marty.mcFly 12 juli 2014 16:59

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    Heb ook Tonix gekocht. Dit aandeel gaat echt skyhigh volgend jaar.
12. [verwijderd] 12 juli 2014 17:39

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    Anderzijds kan je natuurlijk ook stellen; verwachten ze een afkeur zal erna een grotere verwatering optreden dan dat nu het geval is.
13. [verwijderd] 12 juli 2014 20:13

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    Negatief artikel over TNXP, en een indirecte reactie hierop..
    ----
    
    Bioassociate Consulting, Bioassociate (178 clicks)
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    Tonix's Clinical-Stage Drug, TNX-102SL, Is Completely Unneeded
    Mar. 27, 2014 11:17 AM ET | About: Tonix Pharmaceuticals Holding Corp. (TNXP)
    Disclosure: I am short TNXP. (More...)
    Summary
    
    Tonix Pharmaceuticals' clinical-stage product - TNX-102SL is a disintegrating sublingual tablet containing a very low dose of cyclobenzaprine, targeted for bedtime administration for the treatment of Fibromyalgia.
    TNXP was a sub-$5 stock following its recent NASDAQ up-listing until a series of articles drove a stock price rally, regardless of any real fundamental advancements or news.
    Tonix's reformulated cyclobenzaprine doesn't provide any benefits over generic cyclobenzaprine pills that are commonly used as a Fibromyalgia treatment and will not be accepted by physicians and payers.
    Even if TNX-102SL will be FDA approved, its patent expiration date grants only 3 years of market exclusivity. Consequently, Tonix has no chance of even recouping its development costs.
    We argue that Tonix's current market cap is inflated and that Tonix's stock price should be traded only slightly over the company's cash (~$6 per share).
    Background
    
    Tonix Pharmaceuticals (TNXP) is a small virtual company that focuses on developing treatments for CNS conditions related to central pain. Tonix, which currently has only three employees, a CEO and Chairman, a CFO and a CSO, develops a single clinical-stage product - TNX-102 SL, a disintegrating tablet containing a very low dose of cyclobenzaprine (CBP) that is designed for sub-lingual administration at bedtime. Apart from TNX-102 SL, Tonix has a preclinical asset - TNX-201 for the treatment of tension headache. Tonix is initially developing TNX-102 SL as a treatment for Fibromyalgia (FM), a neuropathic pain disorder with unknown etiology, characterized by widespread pain and fatigue. A second indication for this drug candidate is post-traumatic stress disorder (PTSD).
    
    CBP has been approved by the FDA in 1977 for the relief of muscle spasm associated with acute, painful musculoskeletal conditions as an adjunct to rest and physical therapy. A very low dose of bedtime CBP as a treatment for Fibromyalgia was originally developed by Dr. Iredell Iglehart, acquired in 1998 by Vela Pharmaceuticals (founded by Seth Lederman, Tonix's founder and CEO) and returned to Seth Lederman years later, without any major R&D advancements over a period of a decade and a half.
    
    One must question, if TNX-102 is such a promising technology with great commercial potential, why was it held from proper development through all these years? And why did Vela, which was acquired for only $30 million, pass on the opportunity? The answer is simple - because it already exists on the market, and at bottom low pricing.
    
    Due to its currently unknown etiology, treatment options for FM patients include 3 approved drugs: Pfizer's (PFE) Lyrica, Eli Lilly's (LLY) Cymbalta and Forest Laboratories' (FRX) Savella. In addition, FM treatment relies heavily on numerous generic drugs that are prescribed as off-label FM treatments. These drugs include anti-depressants, pain medications and muscle relaxants, one of which is a low dose of bedtime CBP, with its generic 5mg CBP sold for a few cents a pill.
    
    TNX-102 SL for fibromyalgia
    
    Tonix is developing TNX-102 SL as a treatment for FM, stating this is both a reformulation and repurposing of the original drug, CBP (company presentation). While TNX-102 SL is clearly a CBP reformulation (oral to sublingual formulation), claiming it is repurposed is nothing but a demagogic argument since CBP pills (such as Flexeril and Amrix) have been widely used as a FM treatment for many years.
14. [verwijderd] 12 juli 2014 20:13

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    Isn't It Itonic? Dontcha Think? 7 comments
    Mar 31, 2014 6:25 AM | about stocks: TNXP
    Tonix' 2013 Annual Report came out over the weekend, and it is even more delicious than 2012!
    
    Just kidding, that's not even possible.
    
    Anyway, I am not quite done the article to answer last week's short piece (I'll blame the report coming out). Basically I don't think there are any substantive points made in the short piece.
    
    The outline of the article:
    
    A)TNX-102 SL offers many advantages over oral CBP
    
    Per the 10K Tonix has run three Phase I comparative pharmacokinetic and bioavailability studies:
    
    "Our Phase 1 comparative studies showed that TNX-102 SL results in faster systemic absorption and significantly higher plasma levels of CBP in the first hour following administration relative to oral CBP tablets. TNX-102 SL was generally well-tolerated, with no serious adverse events reported in these studies. Some subjects experienced transient numbness on the tongue after TNX-102 SL administration, and other side-effects reported were similar to those associated with current CBP products."
    Then a discussion of the advantages, nCBP has in fact been studied and presented:
    
    As very little information was available on the biochemical effects of CBP and its primary metabolite, norcyclobenzaprine, or nCBP, in the central nervous system, we have engaged several CROs (contract research organizations) to better understand the interactions of these agents with certain receptors in the brain. CROs we have engaged in this effort include Caliper, Cerep, Millipore, and DiscoveRx. Results from a series of binding and functional studies show that both of these molecules are potent antagonists of the serotonin type 2a and the histamine H1 receptors, which known to have effects on sleep and sleep maintenance. The results also show that CBP and nCBP antagonize the adrenergic alpha 1A and 1B receptors, which may have effects on autonomic dysfunction. The results of some of these studies were presented at a poster session during the 2012 American College of Rheumatology Annual Meeting (Daugherty et al, "Cyclobenzaprine (CBP) and its Major Metabolite Norcyclobenzaprine (nCBP) are Potent Antagonists of Human Serotonin Receptor 2a (5-HT2a), Histamine Receptor H1 and Alpha-Adrenergic Receptors: Mechanistic and Safety Implications for Treating Fibromyalgia Syndrome by Improving Sleep Quality", Abstract #960).
    
    Then the fact that drowsiness is in fact a problem with oral CBP.
    
    B)TNX-102 SL Will Be Embraced By Physicians and Payers
    
    potentially reduce abuse of opiates and non-benzo sleep aids
    FM is a very costly disease for patients and payers, in terms of both lost productivity and healthcare costs.
    All of the drugs approved for FM and PTSD are reimbursed by insurers at Tier 2 (preferred brand drug)
    C)TNX-102 SL Is On Schedule
    
    Per 3/11/14 Roth conference file nda 2016 appoval 2017, enrollment is on schedule:
    
    "Enrollment is going as well or better than we expected"
    
    D)TNX-102SL Should Have Many Years of Patent Protection
    
    Roth:
    
    "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."
    
    E) A Valuable Company
    
    FM, PTSD, 201, 301, 2 new two biodefense technologies: one relates to the development of novel smallpox vaccines, and the other the development of protective agents against radiation exposure.
    
    I say buy the dip if it dips any more..
    
    Disclosure: I am long TNXP.
    
    Stocks: TNXP
15. [verwijderd] 13 juli 2014 15:16

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    De CSO van Tonix, Bruce Daugherty ,heeft een behoorlijk staat van dienst; werkverleden bij Merck en Roche.
    Dit onderstaande artikel vind ik ook een interessant gegeven en het vermelden waard.
    --
    
    Tonix hires seasoned drug developer
    
    Apr 1 2014, 10:50 ET | About: Tonix Pharmaceuticals Holding Corp. (TNXP)
    
    Donald J. Kellerman, Pharm. D., joins the Tonix Pharmaceuticals (TNXP +7.5%) executive team as SVP, Clinical Development and Regulatory Affairs. He will guide TNX-102 SL and TNX-201 through the development and regulatory processes.Dr. Kellerman has a successful track record of sheparding products through the development and clinical trial phases. His background includes stints at MAP Pharmaceuticals (acquired by Allergan), Inspire Pharmaceuticals (acquired by Merck), Sepracor (acquired by Dainippon Sumitomo Pharma) as well as several members of Big Pharma.
    
    Comments (2)
    
    Joe Springer , Contributor
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    I didn't know he came from MAP - MAP and Tonix have a lot in common: 505(b)(2), Central Nervous System drug, Pain drug, Women's health product (migraines)…
    
    
16. [verwijderd] 18 juli 2014 15:38

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    CFO geeft verklaring voor recente kleine emissie 11,90 na al een emissie te hebben uitgevoerd op 15,50.
    Institutionele beleggers willen participeren (positief), het geld wordt gebruikt voor klinische doeleinden (positief),
    daarnaast heeft het management aangegeven dat de board zijn aandelen niet verkoopt tot na resultaten BESTFIT (positief).
    Rond 29 september worden de resultaten kenbaar gemaakt; en de verwachtingen van gelovigen zijn geen kattenpis, veelbelovend!
    
    Vandaag mijn belang uitgebouwd.
    
    seekingalpha.com/author/joe-springer/...
    
17. [verwijderd] 18 juli 2014 16:00

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    Gemiddelde aankoop 11,24.
    Ik ben tevreden. Nu ook hier weer een paar maandjes geduld, evenals bij Genfit.
18. [verwijderd] 18 juli 2014 17:48

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    Halozyme ook een mooi verhaal check ticker HALO
19. [verwijderd] 18 juli 2014 17:59

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    Ja veel goedkeuringen in de pijp, samenwerkingen met Pfizer en Roche, maar onvergelijkbaar met Tonix natuurlijk.
    Tonix heeft veel minder concurrentie in een eveneens grote markt, en kan zo een bedrijf zijn die in een gat van de markt springt.
    
    Daarnaast is het bedrijf 10 maal minder gewaardeerd, dus kan het bij positieve resultaten eind september echt vuurwerk worden.
    
    Relatief gezien is het afbreuk risico te overzien (120 MUSD kap), de potentie vanaf dit punt voor de komende 12 maanden erg groot (+/-1000 MUSD kap).
20. [verwijderd] 18 juli 2014 18:26

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    Ik denk dat de weg naar eind september makkelijk nog 50-100% koerswinst tov de huidige koers zal geven.