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Post by JHam on Mar 10, 2015 3:48:38 GMT
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Post by JHam on Mar 10, 2015 7:19:52 GMT
I liked how Lederman was very open about how they failed the primary end point in the BestFit trial and why. Then emphasized that the 30% responder rate was considered statistically significant by experts in the field, despite not having as many dramatic improvers in pain compared to what's already on the market (3:45 - 5:13).
As the TXN 102-SL trials march forward into next year, the biggest upcoming catalyst is the headache trial. Here are my take aways:
- Episodic tension-type headache (ETTH) is the most common type of headache (much more than migraine) and represents a huge market - 75M people in the US experience ETTH *frequently* (one to three headaches over a 3 month period) - 60% of those people receive treatment - Over-the-counter headache drugs (i.e., aspirin, ibuprofin, etc...) do not work for ETTH - No new ETTH drugs have been introduced in over 40 years - The three drugs that are approved to treat ETTH work affectively, however doctors are reluctant to prescribe them because they contain barbiturates that are known to be responsible for abuse and addiction. Also cause rebound headache, over-use headache
If TXN-201 works then it will surely dominate the market as there is no real preferable treatment on the market. P1 was well tolerated and supported their hypothesis. The P2 primary end point is the number of patients who report "pain free" two hours after a single dose. The standard seems set pretty high, so I am a tad concerned that it could fail to meet that end point. It just depends on what percent of pain free responders is considered statistically significant. That said, I guess the idea is that the drug shouldn't be any less efficacious as the older drugs even with removal of the (S) isomer.
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Post by JHam on Mar 10, 2015 8:48:39 GMT
Another take away from this presentation was about the PTSD trial. The P2 AtEase trial is targeting *miltary-related* PTSD. The two drugs currently on the market, Paxil and Zoloft, are SSRI drugs and while they may help with the management of those with non-military-related PTSD, evidence suggests that they do not work for those suffering from military-related PTSD.
8.5M PTSD sufferers in the US alone and despite the desperate need for a drug that provides better management of the disorder, no new drug has been approved in 10 years.
Here is what stood out to me though:
Three of the core symptoms of PTSD; sleep, FIQ-R sensitivity, and FIQ-R anxiety...are also symptoms of fibromyalgia, and showed positive results in the P2 BestFit trial. And that was at the lowest 2.8 mg dose.
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Post by JHam on Mar 10, 2015 14:39:40 GMT
Tanked down to $6.51 right out of the gate, but is now at $7.06. Would have been a nice to have gobbled some more shares on that 8% dip.
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Post by JHam on Mar 10, 2015 15:04:26 GMT
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Post by JHam on Mar 10, 2015 19:36:05 GMT
I strongly encourage anyone who is interested in this stock to listen to the conference from today. It is hard to imagine them not meeting end points on these upcoming trials, considering that they are looking to improve on already approved drugs that offer a lackluster remedy. It looks like TXN-102 SL has the potential to hit the market in the not so distant future. Here are some quotes:
"If positive, the study would be a pivotal study. It's being done at a registration quality method so the primary endpoint is something called the clinician administered PTSD scale. This is same scale that was used for the approval of Paxil and Zoloft...If we're successful in this study we will ask FDA for Breakthrough Designation, cause this is obviously an enormous problem for our society. And we believe that we're the leading company in developing a therapy for Post Traumatic Stress Disorder."
P2 trial results for PTSD are due in 1H 2016.
There were some other really good bits, so it is worth the listen.
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Post by actcfan on Mar 10, 2015 19:53:37 GMT
Thanks for the updates Jham. I have not had time to dig into this one but you sound optimistic so I plan to make time. Do you see near term catalysts (i.e. do I need to do my research soon) or is there time to research and get in here based on the P2 results in 2016? Thanks
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Post by JHam on Mar 10, 2015 19:56:39 GMT
I strongly encourage anyone who is interested in this stock to listen to the conference from today. It is hard to imagine them not meeting end points on these upcoming trials, considering that they are looking to improve on already approved drugs that offer a lackluster remedy. It looks like TXN-102 SL has the potential to hit the market in the not so distant future. Here are some quotes: "If positive, the study would be a pivotal study. It's being done at a registration quality method so the primary endpoint is something called the clinician administered PTSD scale. This is same scale that was used for the approval of Paxil and Zoloft...If we're successful in this study we will ask FDA for Breakthrough Designation, cause this is obviously an enormous problem for our society. And we believe that we're the leading company in developing a therapy for Post Traumatic Stress Disorder." P2 trial results for PTSD are due in 1H 2016. There were some other really good bits, so it is worth the listen. That is, TXN-102 SL could hit the market *for PTSD* in the not so distant future, if results from PTSD are good.
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Post by JHam on Mar 10, 2015 20:14:01 GMT
Thanks for the updates Jham. I have not had time to dig into this one but you sound optimistic so I plan to make time. Do you see near term catalysts (i.e. do I need to do my research soon) or is there time to research and get in here based on the P2 results in 2016? Thanks Near term catalysts: - 2Q P3 trial for Fibromyalgia to begin enrollment - 2Q P2 trial for ETTH to begin enrollment - 4Q Top-line data for ETTH P2 trial released - 1H 2016 P2 top-line data for P2 PTSD trial released I think that is only half of the story though. While the new trial(s) enrollment news may not cause much of a bump, I think that the FDA concluding that the P2 FM trial was indeed statistically significant and giving them the go ahead for P3, that this could/should trickle back up to the pre-trial-fail level ($160M MC, $15 pps). Recently raising $29M, bolstering their cash position to $68M helps things as well. Post dilution, a $150M would be just around $10. Zacks and Roth both have price targets between $11-$12, which seems pretty fair as that trial fail essentially never happened, and one could make the market that after beefing up their cash and launching three new trials that they are stronger than ever.
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Post by JHam on Mar 10, 2015 20:16:40 GMT
So while the near term catalysts may not be big value creators, I think the market will realize sooner rather than later that this is really a $10 stock right now, regardless. That is how I see it at least.
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Post by Yelk on Mar 11, 2015 1:34:03 GMT
So while the near term catalysts may not be big value creators, I think the market will realize sooner rather than later that this is really a $10 stock right now, regardless. That is how I see it at least. I'm hoping for another pull back so I can make my final position However I don't think we will see low $6's again. Oh well! I had a good size position at sub $6 pretty happy. I currently hold 3/4 a full position. I got it at $5.799 on about 1/4 and $6.02 1/4 and 1/4 $6.31 for the rest so about $6.04 average.
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Post by JHam on Mar 11, 2015 7:40:57 GMT
I strongly encourage anyone who is interested in this stock to listen to the conference from today. It is hard to imagine them not meeting end points on these upcoming trials, considering that they are looking to improve on already approved drugs that offer a lackluster remedy. It looks like TXN-102 SL has the potential to hit the market in the not so distant future. Here are some quotes: "If positive, the study would be a pivotal study. It's being done at a registration quality method so the primary endpoint is something called the clinician administered PTSD scale. This is same scale that was used for the approval of Paxil and Zoloft...If we're successful in this study we will ask FDA for Breakthrough Designation, cause this is obviously an enormous problem for our society. And we believe that we're the leading company in developing a therapy for Post Traumatic Stress Disorder." P2 trial results for PTSD are due in 1H 2016. There were some other really good bits, so it is worth the listen. That is, TXN-102 SL could hit the market *for PTSD* in the not so distant future, if results from PTSD are good. By the way these are my words not Lederman's. He simply said if they are successful in P2 they would apply for Breakthrough. I was just putting two and two together. If two drugs that are not very affective were approved based on the same scale that TNXP is using in P2, then it seems logical to conclude that there is a reasonable chance that they could be approved for BT, expediting the time to commercialization. Again if successful. I am obviously getting way ahead of myself with that, but just wanted to point out that the PTSD drug could be the first to hit the market out of the three. Lederman did a lot of emphasizing on the point that these drugs are not cures. They are long term treatments that they feel patients will be able to use affectively for decades. He also made it clear that they are not an orphan company and that they are targeting indications with huge markets.
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Post by actcfan on Mar 11, 2015 15:50:08 GMT
Thanks for the updates Jham. I have not had time to dig into this one but you sound optimistic so I plan to make time. Do you see near term catalysts (i.e. do I need to do my research soon) or is there time to research and get in here based on the P2 results in 2016? Thanks Near term catalysts: - 2Q P3 trial for Fibromyalgia to begin enrollment - 2Q P2 trial for ETTH to begin enrollment - 4Q Top-line data for ETTH P2 trial released - 1H 2016 P2 top-line data for P2 PTSD trial released I think that is only half of the story though. While the new trial(s) enrollment news may not cause much of a bump, I think that the FDA concluding that the P2 FM trial was indeed statistically significant and giving them the go ahead for P3, that this could/should trickle back up to the pre-trial-fail level ($160M MC, $15 pps). Recently raising $29M, bolstering their cash position to $68M helps things as well. Post dilution, a $150M would be just around $10. Zacks and Roth both have price targets between $11-$12, which seems pretty fair as that trial fail essentially never happened, and one could make the market that after beefing up their cash and launching three new trials that they are stronger than ever. Thanks Jham. I took a very small position last month after reading one of your posts (helps me keep an eye on it) and am already up 10%!! Will dig in though and see if i might buy a substantial position.
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Post by JHam on Mar 11, 2015 16:41:26 GMT
Near term catalysts: - 2Q P3 trial for Fibromyalgia to begin enrollment - 2Q P2 trial for ETTH to begin enrollment - 4Q Top-line data for ETTH P2 trial released - 1H 2016 P2 top-line data for P2 PTSD trial released I think that is only half of the story though. While the new trial(s) enrollment news may not cause much of a bump, I think that the FDA concluding that the P2 FM trial was indeed statistically significant and giving them the go ahead for P3, that this could/should trickle back up to the pre-trial-fail level ($160M MC, $15 pps). Recently raising $29M, bolstering their cash position to $68M helps things as well. Post dilution, a $150M would be just around $10. Zacks and Roth both have price targets between $11-$12, which seems pretty fair as that trial fail essentially never happened, and one could make the market that after beefing up their cash and launching three new trials that they are stronger than ever. Thanks Jham. I took a very small position last month after reading one of your posts (helps me keep an eye on it) and am already up 10%!! Will dig in though and see if i might buy a substantial position. Thanks! I would love to hear any thoughts you have on this one. Especially anything that punches holes in what I have posted so far.
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Post by JHam on Mar 12, 2015 3:33:17 GMT
Nice to see this one continue to march forward. Even hit $7.25 at one point. I was thinking to add more anywhere under $6.50, but not sure if we'll get their again.
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Post by Yelk on Mar 12, 2015 3:38:24 GMT
Nice to see this one continue to march forward. Even hit $7.25 at one point. I was thinking to add more anywhere under $6.50, but not sure if we'll get their again. I added today at $6.91. Still room for final addition if there's a dip.
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Post by JHam on Mar 12, 2015 14:06:50 GMT
Nice to see this one continue to march forward. Even hit $7.25 at one point. I was thinking to add more anywhere under $6.50, but not sure if we'll get their again. I added today at $6.91. Still room for final addition if there's a dip. Looks like it was a good add. Just hit $7.41. Damn I wish I would have bought more of this one. Have a healthy medium position, but wish it were a large one.
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Post by JHam on Mar 13, 2015 9:49:07 GMT
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Post by JHam on Mar 13, 2015 18:59:54 GMT
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Post by Yelk on Mar 13, 2015 20:35:02 GMT
Thanks for the update JHam! Looking for higher here!
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