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Post by Yelk on Feb 27, 2015 15:38:44 GMT
Doubled down fully my position today at $6.05. Will keep adding I think as time goes on, especially if we go sub $6.
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Post by JHam on Feb 28, 2015 15:18:47 GMT
Lots of Form 4s reported yesterday.
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Post by Yelk on Mar 1, 2015 0:00:23 GMT
Lots of Form 4s reported yesterday. Does that signify insider buying? Forms is a weakness for me in my DD. I'l be trying to learn them this year - was just prioritizing what was more important first.
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Post by Yelk on Mar 1, 2015 0:22:16 GMT
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Post by JHam on Mar 1, 2015 0:45:26 GMT
Yeah I posted the link to this a page back. thebiotechinvestor.freeforums.net/post/15939/threadThe interviewer is a big fan of Tonix and has written some articles about them. So I am not sure this is the most balanced interview ever. Other than that though it is good to put a face to company leadership and hear what they have to say. There was some good new information (to me at least) in that I mentioned in my post before.
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Post by JHam on Mar 1, 2015 1:00:56 GMT
Lots of Form 4s reported yesterday. Does that signify insider buying? Forms is a weakness for me in my DD. I'l be trying to learn them this year - was just prioritizing what was more important first. No they are just stock option awards. It is not weak or great. Just part of the normal way management in companies award themselves stock. Although Lederman did just gift himself over $1M in options after a failed trial and loss of over half the value of the company, so that may rub people the wrong way. However, this is part of their 2014 stock incentive plan, so it was set to happen a long time ago. They won't fully vest for a while so I'll probably be out of this stock by the time they'll be able to exercise them anyway. Even if not, it's not that big of a deal.
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Post by JHam on Mar 1, 2015 1:38:42 GMT
For anyone interested, here is the stock incentive plan from the 10K. Forget about what I said regarding the options vesting as the highlighted below is all that matters. 10% owners (Lederman) can't exercise these unless the share price is 110% above the purchase price ($5.95), and less than 10% owners (everyone else) can't exercise unless the share price is 100% above $5.95. Which means if they are able to exercise these options those of us who have bought in the past few weeks will have done quite well with this stock: www.sec.gov/Archives/edgar/data/1430306/000114420415012769/v402310_10k.htm2014 incentive stock option plan On June 9, 2014, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. 2014 Stock Incentive Plan (the “2014 Plan” and together with the 2012 Plan, the “Plans”). Under the terms of the 2014 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, or RSUs, (5) other stock-based awards, and (6) cash-based awards. The 2014 Plan provides for the issuance of up to 1,800,000 shares of common stock, provided, however, that, of the aggregate number of 2014 Plan shares authorized, no more than 200,000 of such shares may be issued pursuant to stock-settled awards other than options (that is, restricted stock, RSUs, SARs, performance awards, other stock-based awards and dividend equivalent awards, in each case to the extent settled in shares of common stock). The Board of Directors determines the exercise price, vesting and expiration period of the grants under the 2014 Plan. However, the exercise price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in absence of such quoted market price, by the Board of Directors in good faith. Additionally, the vesting period of the grants under the 2014 Plan may not be more than five years and expiration period not more than ten years. The Company reserved 1,800,000 shares of its common stock for future issuance under the terms of the 2014 Plan.
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Post by JHam on Mar 1, 2015 1:48:25 GMT
Also, Lederman has bought a lot of shares over the years and and based on openinsider.com don't believe he has ever sold.
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Post by JHam on Mar 1, 2015 2:08:39 GMT
Some good stuff here in this 10K. This is all you need to know about TNX-102 SL and the trial(s):
Clinical Development Plan At an End-of-Phase 2/Pre-Phase 3 meeting with the FDA in February 2013, we discussed the design of our clinical program, including the acceptability of the pivotal study design and the proposed registration plan, to support the approval of TNX-102 SL for the management of FM. On the basis of our discussions with the FDA, we believe that positive results from two adequate, well-controlled efficacy and safety studies and long-term (six- and 12-month) safety exposure studies would provide sufficient evidence of efficacy and safety to support FDA approval of TNX-102 SL for the management of FM. Phase 2b “BESTFIT” Study In September 2013, we commenced enrollment of our BESTFIT trial, a randomized, double-blind, placebo-controlled Phase 2b clinical trial of TNX-102 SL in FM. We reported preliminary top-line results from the BESTFIT trial in September 2014. In the BESTFIT trial, 205 patients with FM were randomized at 17 U.S. centers to treatment with either TNX-102 SL 2.8 mg or placebo sublingual tablets at bedtime daily for 12 weeks. The primary outcome measure of the BESTFIT trial was the mean change in week 12 average daily pain intensity from baseline on the 11-point Numeric Rating Scale, using a daily telephonic diary. In the BESTFIT trial, TNX-102 SL did not achieve statistical significance in the primary outcome measure (p=0.172). However, the trial demonstrated that TNX-102 SL had a statistically significant effect on pain as measured by a 30% responder analysis of the primary pain data (p=0.033), in which a responder is defined as a subject for whom pain intensity was reduced by at least 30% at week 12 as compared to baseline. The 30% response rate in the final analysis was 34.0% in the active treatment arm as compared to 20.6% in the control arm. The BESTFIT trial also showed statistically significant improvements with TNX-102 SL in the declared secondary analyses of the Patient Global Impression of Change (p=0.025) and the Fibromyalgia Impact Questionnaire-Revised, or FIQ-R (p=0.014). The study showed statistically significant improvement with TNX-102 SL on measures of sleep quality, including the Patient-Reported Outcomes Measurement Information System, or PROMIS, Sleep Disturbance instrument (p=0.005). In addition, statistically significant improvements with TNX-102 SL were observed on several FIQ-R items (pain, sleep quality, anxiety, stiffness, and sensitivity) as well as on the overall symptom subdomain. TNX-102 SL was well tolerated in the BESTFIT trial. Among subjects randomized to the active and control arms, 86% and 83%, respectively, completed the 12-week dosing period. The most common adverse events were local in nature, with transient tongue or mouth numbness occurring in 42% of participants on TNX-102 SL vs. 1% on placebo, and bitter taste in 8% on TNX-102 SL compared to none on placebo. These local adverse events did not appear to affect either rates of retention of study participants or their compliance with taking TNX-102 SL. Systemic adverse events were similar between TNX-102 SL and placebo. No serious adverse events were reported. Prospective First Phase 3 Study Following our report of the results of the BESTFIT trial, we requested guidance from the FDA on our proposed use of a 30% pain responder analysis as the primary efficacy endpoint in our prospective Phase 3 clinical trial. In January 2015, we announced receipt of the written guidance, whereby the FDA accepted our proposal to use a 30% pain responder analysis as the primary efficacy endpoint in our Phase 3 trial to support the approval of TNX-102 SL for the management of FM. We expect to initiate a randomized, double-blind, placebo-controlled, 12-week Phase 3 trial of TNX-102 SL in 500 patients with FM in the second quarter of 2015. We expect to report top line results from this trial in the second half of 2016.
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Post by JHam on Mar 1, 2015 2:44:27 GMT
(cont'd)
TNX-102 SL – Post-traumatic Stress Disorder Program We are developing TNX-102 SL for the management of PTSD under a separate IND allowed by the FDA in June 2014, and we are currently conducting our AtEase trial, a Phase 2 clinical trial of TNX-102 SL in military-related PTSD. Parallels between Fibromyalgia and Post-traumatic Stress Disorder The clinical presentations of FM and PTSD share a number of similarities and clinical overlap. For example, in a survey of males with PTSD or major depression, 49% of PTSD patients met the American College of Rheumatology criteria for FM compared to 5% of major depression patients (Amital et al, J Psychosom Res 2006;61:663-669). Conversely, in a different survey of FM patients, 57% of the patients had symptoms associated with PTSD (Cohen et al, Semin Arthritis Rheum 2002;32:38-50). As with FM, a core feature of PTSD is sleep disturbance. Sleep disturbances are believed to exacerbate daytime symptoms of PTSD, including irritability, poor concentration, and diminished interest in significant activities. The sleep disturbances of PTSD, which include nightmares and night terrors, may be more pronounced than those typically experienced by FM patients. Development Rationale Our rationale for developing TNX-102 SL for treatment of PTSD derives from the following: ž Results from our BESTFIT study, which showed that treatment with TNX-102 SL: 1) improves FM symptoms, a disorder having significant overlap with PTSD; and 2) improves sleep quality in FM, which is impaired in PTSD; and ž In research from peer-reviewed scientific publications, we have identified a number of compounds that are antagonists of the serotonin 2A or alpha-1 adrenergic receptors that have been shown to have beneficial effects in treating PTSD. Therefore, it is our belief that TNX-102 SL, a serotonin 2A and alpha-1 adrenergic receptor antagonist, will have a therapeutic effect in treating PTSD. Clinical Development Plan In January 2015, we commenced the AtEase trial, a 220-patient, randomized, double-blind, placebo-controlled, 12-week Phase 2 trial of TNX-102 SL in subjects with military-related PTSD. This trial will be conducted at approximately 25 U.S. centers. The AtEase trial is designed to study the efficacy and safety of two doses of TNX-102 SL (2.8 mg and 5.6 mg) administered once daily at bedtime. The primary objective of the AtEase trial is to evaluate the efficacy of TNX-102 SL 2.8 mg as compared to placebo sublingual tablet following eight weeks of treatment using the Clinician-Administered PTSD Scale. If the results of the AtEase trial are positive, we intend to meet with the FDA to finalize the design of the registration program that would be required to support approval of an NDA for this indication. Based on our communications with the FDA to date, we believe that positive results from two adequate, well-controlled efficacy and safety studies and long-term (six- and 12-month) safety exposure studies would support FDA approval of TNX-102 SL for the management of PTSD. If we achieve our primary outcome measure in the AtEase study, it could qualify as one of the two studies required to support the NDA. We expect that we can use the long-term safety exposure data generated by our clinical development of TNX-102 SL in FM to supplement the long-term safety exposure data required for the PTSD NDA.
Regulatory Strategy The approvals by the FDA of Paxil and Zoloft for treating PTSD established a regulatory approval pathway for symptom reduction in PTSD. We believe our clinical development program of TNX-102 SL and the long term safety data generated from the TNX-102 SL NDA for FM will result in a differentiated product suitable for chronic use for the treatment of PTSD. We believe that our ongoing and planned clinical trials in PTSD, if successful, will provide sufficient evidence of clinical efficacy and safety to support a 505(b)(2) NDA for TNX-102 SL for the management of PTSD. We plan to meet with the FDA when we complete the AtEase study to further discuss our development plan for TNX-102 SL for PTSD, especially the proposed design of the pivotal studies. If the results from the AtEase study are positive, we plan to seek a Breakthrough Therapy designation for TNX-102 SL in PTSD. The Breakthrough Therapy designation process is a new and uncertain process, in which the majority of requests for designation have been denied. Given TNX-102 SL’s pharmacological mode of action, its ability to significantly improve sleep quality as demonstrated in the BESTFIT trial, and the lack of Drug Enforcement Agency scheduling of CBP, we believe TNX-102 SL, if approved, has the potential to serve as an important and differentiated new option for the management of PTSD.
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Post by JHam on Mar 1, 2015 2:57:21 GMT
Here are a few things I learned from reading through this 10K:
1) The FM trial and the PTSD trial will dovetail off of each other. The FDA will let them use the the long term safety data from the FM trial for PTSD since it is the same drug, dramatically shortening the PTSD trial time needed in order to go into a pivotal trial.
2) If the PTSD trial is successful, they plan to immediately file for Breakthrough Designation. TXN-102 SL for PTSD could essentially beat FM to the market, thanks in large part to being able to use the data from the FM trial.
3) The similarities between FM and PTSD are far more similar than PTSD and depression.
4) (I kind of knew this before) TXN-102 SL is being used in FM to treat pain and also sleep deprivation. However, in PTSD it is being used solely to treat quality of sleep. One drug, two separate and large markets.
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Post by JHam on Mar 1, 2015 3:01:43 GMT
This is also pretty neat:
Additional Product Candidates We also have a pipeline of other product candidates, including TNX-301. TNX-301 is a fixed dose combination drug product, or CDP, containing two FDA-approved drugs, disulfiram and selegiline. We intend to develop TNX-301 CDP under Section 505(b)(2) of the FDCA as a potential treatment for alcohol abuse and dependence, and we have commenced development work on TNX-301 formulations. In addition, we own rights to intellectual property on two biodefense technologies: one relating to the development of novel smallpox vaccines; and the other to the development of protective agents against radiation exposure. We have begun non-clinical research and development on these programs. The FDA Animal Efficacy Rule provides a mechanism for product licensure when human efficacy studies are not feasible or ethical. As a result, the licensure of these biodefense products in the U.S. may not require human efficacy studies, which we believe will reduce our development costs and risks compared to the development of other NCEs or new biologic candidates.
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Post by Yelk on Mar 1, 2015 5:11:21 GMT
Thanks for all the comments and info JHam. Can you comment on your post about "not being in the stock when that happens." I see benefits of going long here so curious if you plan to time your trading for shorter run up only. (2 posts down from my last post)
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Post by Yelk on Mar 1, 2015 5:13:03 GMT
Does that signify insider buying? Forms is a weakness for me in my DD. I'l be trying to learn them this year - was just prioritizing what was more important first. No they are just stock option awards. It is not weak or great. Just part of the normal way management in companies award themselves stock. Although Lederman did just gift himself over $1M in options after a failed trial and loss of over half the value of the company, so that may rub people the wrong way. However, this is part of their 2014 stock incentive plan, so it was set to happen a long time ago. They won't fully vest for a while so I'll probably be out of this stock by the time they'll be able to exercise them anyway. Even if not, it's not that big of a deal. This is the one, thats easier
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Post by JHam on Mar 1, 2015 5:54:46 GMT
No they are just stock option awards. It is not weak or great. Just part of the normal way management in companies award themselves stock. Although Lederman did just gift himself over $1M in options after a failed trial and loss of over half the value of the company, so that may rub people the wrong way. However, this is part of their 2014 stock incentive plan, so it was set to happen a long time ago. They won't fully vest for a while so I'll probably be out of this stock by the time they'll be able to exercise them anyway. Even if not, it's not that big of a deal. This is the one, thats easier I just mean that a 100% gain would be huge for me, so there is a good chance I would exit most if not all of my position at that point. Especially if most of that gain happens during a run-up to trial data. It really depends on how things have unfolded down the stretch. I made that post before I read the 10K though. The more that I think about it, there is a chance none of them will exercise those options anyway. Even if they did, it wouldn't be the end of the world anyway.
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Post by Yelk on Mar 1, 2015 6:14:52 GMT
This is the one, thats easier I just mean that a 100% gain would be huge for me, so there is a good chance I would exit most if not all of my position at that point. Especially if most of that gain happens during a run-up to trial data. It really depends on how things have unfolded down the stretch. I made that post before I read the 10K though. The more that I think about it, there is a chance none of them will exercise those options anyway. Even if they did, it wouldn't be the end of the world anyway. Maybe I'm overly optimistic but is it possible we will see more than 100% run-up alone? Unless I'm missing something. As I always say I love good discussion so if you see anything wrong with my analysis have at it please. Before P2 the PPS was sitting above $14. Our current situation at sub $6: -Going into P3 to prove already found results (obviously still risky but raises interest IMO) -2 other studies and we already know the drug affects sleep in a good way from P2 fibromyalgia study -This tiny float can't stay down much if we see more institutional/speculative interest -The drug itself is easy to administer, safe, doesn't have barbiturate/opium adverse side affects which IMO raise value over other choices- Cash to get us past all 3 study data read outs and then some- All 3 data read outs will be close together, probably 2 in 1H 2016 and P3 Q3 2016 spurring stock up to first data read out (correction one Q4 2015) -Already early excellent institutional/insider support -Massive market if successful -Exclusive world wide rights and patents into the 2030's makes excellent big pharma interest rise I can easily see a massive buildup in 2016 in anticipation of 3 data read outs with investors knowing 1) there will be a run-up and 2) there will be no more financing. This seems to be almost like a Nuvo Research with minimal risk until data read outs. I can also see institutional interest rise with 3 active trials - it's my belief with this tiny market cap and future demand we could see more than the $10-$12 TP. I'd love a discussion around this though!! My current plan is to place profits from other companies in to this as I consider this very low risk (as low risk as some biotechs can be) and build a large position and take chunks of profits starting at $9. PS why was the stock up at $19 almost at one point... I am looking into that now. Just curious what changed as we have so much going now. I read some older articles of Jason Napodano who wrote an article on Nov 2013 right before the stock rose 500% to buy Tonix. Nothing has really changed between now and then in fact it looks much better now. I guess market valuations change but IMO the $ potential is the same. One big thing that I see is a plus here is that Savella was approved on responder analysis as primary outcome which is the same as P3 TNX-102SL. So far it has shown superior numbers over the P2 trial of Savella. That is a pretty strong statement I think.
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Post by JHam on Mar 1, 2015 6:28:32 GMT
Here is all of info about the ETTH "headache" trial in the 10K. I'll post it in its entirety below and then comment in a separate post:
TNX-201 – Episodic Tension-Type Headache Program We are developing TNX-201 for the treatment of ETTH under an IND cleared by the FDA in October 2014. TNX-201 is an oral formulation of (R)-isometheptene mucate, a single isomer of isometheptene mucate, or IMH, which we are developing for episodic tension-type headache. We own all rights to TNX-201 in all geographies, and we bear no obligations to third-parties for any future development or commercialization. Although currently not approved for any indication, IMH has an extensive history of use as a prescription pharmaceutical in the U.S. as a racemic mixture, which consists of two mirror-image isomers, or IMH enantiomers. Racemic IMH has been marketed as Octin® for conditions including tension and vascular headache. In addition, racemic IMH has been marketed in combination products for the relief of tension and vascular headaches (examples include Midrin®, MigraTen® and Prodrin®). Between 1990 and 1998, Midrin was the second most-widely prescribed headache medication in the U.S. (Gibbs et al, Headache 2003;43:330-335). Products containing IMH were first commercialized in the U.S. between 1938 and 1962. As introduced in 1938, the FDCA required that new drugs be approved for evidence of safety, with no requirement for evidence of efficacy. In 1962, Congress amended the FDCA to require substantial evidence of efficacy, as well as safety, for a drug to be granted FDA approval, and at that time the FDA introduced the Drug Efficacy Study Implementation program, or DESI, to evaluate the effectiveness of drugs approved between 1938 and 1962. Under the DESI, products containing IMH are currently sanctioned from marketing by the FDA, although certain combination drug products containing IMH remain on the market in the “Unapproved Drug Other” category. Based on our evaluation studies, we believe that (R)-isometheptene mucate, which we are developing as TNX-201, is primarily responsible for the efficacy associated with racemic IMH in the treatment of headache, and that (S)-isometheptene mucate, the other IMH enantiomer, may be associated with toxic or undesirable pharmacologic effects. As a result, we believe that TNX-201 may possess an improved clinical profile as compared to the unapproved, but previously marketed, racemic IMH for headache indications. According to the FDA’s Stereoisomeric Drugs Development Policy, the development of a single enantiomer of a racemic drug is particularly desirable in cases in which one enantiomer has a toxic or undesirable pharmacologic effect and the other does not. Preclinical studies conducted under our direction have shown that TNX-201 significantly increases the pain threshold in standard animal models of acute pain response. These studies have also shown that TNX-201 strongly and selectively binds to receptors in the CNS known as imidazoline type-1 (I1) receptors, where it acts as a receptor agonist. In January 2014, we held a pre-IND meeting with the FDA to discuss the regulatory pathway for the development of TNX-201 for the treatment of ETTH. We have completed a comparative Phase 1 single ascending dose safety, tolerability, and pharmacokinetic study of TNX-201 in 45 healthy volunteers, from which we reported top line results in January 2015. The clinical results showed that TNX-201 was well-tolerated at all doses studied (35 mg, 70 mg, and 140 mg), and pharmacokinetic analyses demonstrated dose-proportionality of parameters including area under the curve and maximum concentration. The absence of any appreciable amount of (S)-isometheptene in TNX-201 study samples indicated the lack of conversion of (R)-isometheptene to the other enantiomer, a finding which supports the rationale of developing TNX-201, a single isomer of IMH. We are preparing to commence a 200-patient Phase 2 study in ETTH in the second quarter of 2015, in which patients will be randomized at approximately 10 U.S. centers to receive TNX-201 140 mg (4 x 35 mg) or placebo capsules. The primary efficacy endpoint will be the difference between the two study arms in the number of subjects who report complete relief from their headache pain at two hours following a dose of study medication. We expect to report top line results from this study in the fourth quarter of 2015. Although the clinical development of TNX-201 can be accelerated based on the available information on racemic IMH, approval of any NDA will be as a new chemical entity pursuant to Section 505(b)(1) of the FDCA. We are developing TNX-201 with the goal of introducing a safe, effective, and non-addictive treatment option for ETTH.
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Post by JHam on Mar 1, 2015 6:49:17 GMT
To sum the headache trial up. There are already drugs on the market that address this indication. However they include the "other" IMH enantiomer, (S)-isometheptene mucate, which has been associated with toxic effects. Tonix is developing TNX-201 (not to be confused with TNX-102 SL) as a non-toxic, safer version of these drugs already approved, simply by eliminating the "other" toxic IMH enantiomer, but keeping the "good" enantiomer and its beneficial qualities.
P1 results supported their development rationale. The only thing that concerns me about this trial is that the primary endpoints are set very high. They are measuring patients who have "complete relief" of symptoms two hours after taking the dose. Maybe the other products on the market give complete relief of headache symptoms within two hours of dosing, and this isn't an unachievable end point. So I don't know, it just seems high. We need to know the response rate percentage they have decided upon.
Top-line results from this trial will be ready by 4Q and possibly even sooner. Of the 3 programs this will be the first data set we'll see. It is completely different than TNX-102 SL so there is a risk there unassociated with the FM and trials. Luckily, I think that the headache trial is more gravy and the two TNX-102 SL trials are the meat trials, and pose less risk at this point (especially FM).
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Post by JHam on Mar 1, 2015 7:04:20 GMT
I just mean that a 100% gain would be huge for me, so there is a good chance I would exit most if not all of my position at that point. Especially if most of that gain happens during a run-up to trial data. It really depends on how things have unfolded down the stretch. I made that post before I read the 10K though. The more that I think about it, there is a chance none of them will exercise those options anyway. Even if they did, it wouldn't be the end of the world anyway. Maybe I'm overly optimistic but is it possible we will see more than 100% run-up alone? Unless I'm missing something. As I always say I love good discussion so if you see anything wrong with my analysis have at it please. Before P2 the PPS was sitting above $14. Our current situation at sub $6: -Going into P3 to prove already found results (obviously still risky but raises interest IMO) -2 other studies and we already know the drug affects sleep in a good way from P2 fibromyalgia study -This tiny float can't stay down much if we see more institutional/speculative interest -The drug itself is easy to administer, safe, doesn't have barbiturate/opium adverse side affects which IMO raise value over other choices- Cash to get us past all 3 study data read outs and then some- All 3 data read outs will be close together, probably 2 in 1H 2016 and P3 Q3 2016 spurring stock up to first data read out (correction one Q4 2015) -Already early excellent institutional/insider support -Massive market if successful -Exclusive world wide rights and patents into the 2030's makes excellent big pharma interest rise I can easily see a massive buildup in 2016 in anticipation of 3 data read outs with investors knowing 1) there will be a run-up and 2) there will be no more financing. This seems to be almost like a Nuvo Research with minimal risk until data read outs. I can also see institutional interest rise with 3 active trials - it's my belief with this tiny market cap and future demand we could see more than the $10-$12 TP. I'd love a discussion around this though!! My current plan is to place profits from other companies in to this as I consider this very low risk (as low risk as some biotechs can be) and build a large position and take chunks of profits starting at $9. PS why was the stock up at $19 almost at one point... I am looking into that now. Just curious what changed as we have so much going now. I read some older articles of Jason Napodano who wrote an article on Nov 2013 right before the stock rose 500% to buy Tonix. Nothing has really changed between now and then in fact it looks much better now. I guess market valuations change but IMO the $ potential is the same. One big thing that I see is a plus here is that Savella was approved on responder analysis as primary outcome which is the same as P3 TNX-102SL. So far it has shown superior numbers over the P2 trial of Savella. That is a pretty strong statement I think. Yelk, In general I agree. Don't worry I am not suddenly bearish on TNXP or anything lol. $160M is my magic number. That was the average market it held for a few months prior to P2b results. Since that trial failed, the company has turned around in a lot of ways. Increased their cash position, were approved to start P3, and have started enrolling in a separate P2 trial (PTSD), whose primary endpoints were essentially already met in the FM P2b trial. So it my mind, the stock should be at least trading back at a $160M market cap ($10). That would be a huge gain from its sub $6 price today and would be tough to not take some off the table at that point. I agree that it could easily run back up to $160M and past that prior to trial results. That is more of my concern than insiders exercising options. They mentioned that we will get an enrollment update on the PTSD trial in the 1H 2015. If they include any positive interim data then that could do a lot for this stock. Also if any of these trials report positive top-line data then I think the sky is the limit for this one. Especially with such a low float. We'll see. If I do well in some of the other stocks I am holding at the moment in the next few months, I'll probably feel more daring on holding the majority of my TNXP shares through data results. As for right now I feel really bullish on this stock on will probably continue to add.
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Post by Yelk on Mar 1, 2015 7:16:48 GMT
Maybe I'm overly optimistic but is it possible we will see more than 100% run-up alone? Unless I'm missing something. As I always say I love good discussion so if you see anything wrong with my analysis have at it please. Before P2 the PPS was sitting above $14. Our current situation at sub $6: -Going into P3 to prove already found results (obviously still risky but raises interest IMO) -2 other studies and we already know the drug affects sleep in a good way from P2 fibromyalgia study -This tiny float can't stay down much if we see more institutional/speculative interest -The drug itself is easy to administer, safe, doesn't have barbiturate/opium adverse side affects which IMO raise value over other choices- Cash to get us past all 3 study data read outs and then some- All 3 data read outs will be close together, probably 2 in 1H 2016 and P3 Q3 2016 spurring stock up to first data read out (correction one Q4 2015) -Already early excellent institutional/insider support -Massive market if successful -Exclusive world wide rights and patents into the 2030's makes excellent big pharma interest rise I can easily see a massive buildup in 2016 in anticipation of 3 data read outs with investors knowing 1) there will be a run-up and 2) there will be no more financing. This seems to be almost like a Nuvo Research with minimal risk until data read outs. I can also see institutional interest rise with 3 active trials - it's my belief with this tiny market cap and future demand we could see more than the $10-$12 TP. I'd love a discussion around this though!! My current plan is to place profits from other companies in to this as I consider this very low risk (as low risk as some biotechs can be) and build a large position and take chunks of profits starting at $9. PS why was the stock up at $19 almost at one point... I am looking into that now. Just curious what changed as we have so much going now. I read some older articles of Jason Napodano who wrote an article on Nov 2013 right before the stock rose 500% to buy Tonix. Nothing has really changed between now and then in fact it looks much better now. I guess market valuations change but IMO the $ potential is the same. One big thing that I see is a plus here is that Savella was approved on responder analysis as primary outcome which is the same as P3 TNX-102SL. So far it has shown superior numbers over the P2 trial of Savella. That is a pretty strong statement I think. Yelk, In general I agree. Don't worry I am not suddenly bearish on TNXP or anything lol. $160M is my magic number. That was the average market it held for a few months prior to P2b results. Since that trial failed, the company has turned around in a lot of ways. Increased their cash position, were approved to start P3, and have started enrolling in a separate P2 trial (PTSD), whose primary endpoints were essentially already met in the FM P2b trial. So it my mind, the stock should be at least trading back at a $160M market cap ($10). That would be a huge gain from its sub $6 price today and would be tough to not take some off the table at that point. I agree that it could easily run back up to $160M and past that prior to trial results. That is more of my concern than insiders exercising options. They mentioned that we will get an enrollment update on the PTSD trial in the 1H 2015. If they include any positive interim data then that could do a lot for this stock. Also if any of these trials report positive top-line data then I think the sky is the limit for this one. Especially with such a low float. We'll see. If I do well in some of the other stocks I am holding at the moment in the next few months, I'll probably feel more daring on holding the majority of my TNXP shares through data results. As for right now I feel really bullish on this stock on will probably continue to add. Yeah - the reason I want to have as much in before hand in as possible is because of the float size. When this thing goes to $9 it will probably be like 2 days after some small announcement that was just enough to spur it. Once it is at 9 you lose that gain multiplier from 6. I'm pretty much in the same position - it all depends on how things go. I've got about 6 major data/FDA events in the next 40 days for my stocks at least so there is a lot happening...
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