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Post by jckrdu on Feb 15, 2015 3:42:32 GMT
Point of clarification, I believe the next step is phase 2b, not phase 3. I can see the company submitting for BTD after this data is compiled which should help accelerate commercialization, but it definitely won't be 2 years if they're asked to do a phase 3. I think it was the stroke trial in China that they could commercialize in 2 years (more likely 2.5 years). That's what I thought the CEO guided during last week's presentation... Phase 2b is next for ALS. I'll have to re-listen & relook at the slides.
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Post by jckrdu on Feb 15, 2015 15:05:54 GMT
Point of clarification, I believe the next step is phase 2b, not phase 3. I can see the company submitting for BTD after this data is compiled which should help accelerate commercialization, but it definitely won't be 2 years if they're asked to do a phase 3. I think it was the stroke trial in China that they could commercialize in 2 years (more likely 2.5 years). That's what I thought the CEO guided during last week's presentation... Phase 2b is next for ALS. I'll have to re-listen & relook at the slides. See slide 17 of the last slide deck from the 2/9/2015 conference:
"Phase IIb ALS Expected Commencement 2Q/3Q".
So, latest guidance is a Phase 2b for ALS. Question is, will that Phase 2b be pivotal?
www.veracast.com/webcasts/bio/ceoinvestor2015/68122195901.cfm
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Post by jckrdu on Feb 15, 2015 16:21:42 GMT
That's what I thought the CEO guided during last week's presentation... Phase 2b is next for ALS. I'll have to re-listen & relook at the slides. See slide 17 of the last slide deck from the 2/9/2015 conference:
"Phase IIb ALS Expected Commencement 2Q/3Q".
So, latest guidance is a Phase 2b for ALS. Question is, will that Phase 2b be pivotal?
www.veracast.com/webcasts/bio/ceoinvestor2015/68122195901.cfm
It's also possible that CUR applied for Breakthrough Designation based in the Phase 2 results that - according to one of Yelk's prior posts - was locked on July 30th and sent to the FDA in August of 2014.
Dr. Feldman is a big believer in the data, so I think its possible CUR applied for Breakthrough Designation last summer or fall based on the Phase 2 data.
In terms of overall movement of the pps...
Near-term - I think the pre-data release run-up has farther to go. I think CUR will be trading in the $4s sometime over the next 1-2 weeks.
Longer-term - Agree with Yelk that the results will be good, but some subset of patients won't respond... which may put meeting the primary efficacy endpoint at risk. I think they'll state that they know the target patient population that will see great results, and that'll help with the Phase 2b. IMO, the PPS direction after the results are announced will have as much to do (or more to do) with the timeframes they do or don't guide; Will Phase 2B be pivotal? Did they apply for Breakthrough Designation? If we find out the answer to both those 2 questions are "No" - indicating a Phase 3 will be needed - then I don't see this spiking much higher than $5-$6ish even on great results.
China stroke results/guidance on early commercialization in China is the wildcard.
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Post by Yelk on Feb 15, 2015 16:46:50 GMT
It's also possible that CUR applied for Breakthrough Designation based in the Phase 2 results that - according to one of Yelk's prior posts - was locked on July 30th and sent to the FDA in August of 2014.
Dr. Feldman is a big believer in the data, so I think its possible CUR applied for Breakthrough Designation last summer or fall based on the Phase 2 data.
In terms of overall movement of the pps...
Near-term - I think the pre-data release run-up has farther to go. I think CUR will be trading in the $4s sometime over the next 1-2 weeks.
Longer-term - Agree with Yelk that the results will be good, but some subset of patients won't respond... which may put meeting the primary efficacy endpoint at risk. I think they'll state that they know the target patient population that will see great results, and that'll help with the Phase 2b. IMO, the PPS direction after the results are announced will have as much to do (or more to do) with the timeframes they do or don't guide; Will Phase 2B be pivotal? Did they apply for Breakthrough Designation? If we find out the answer to both those 2 questions are "No" - indicating a Phase 3 will be needed - then I don't see this spiking much higher than $5-$6ish even on great results.
China stroke results/guidance on early commercialization in China is the wildcard.
I've read the blog of 3 of the patients from P2 trial so we know it does do something. It all depends on the results. If 2/3 of the patients respond very well I think we could peak at $8-$9 (not hold but peak). Will probably go to $5-$6 between news and next trial run-up. The science behind how CUR and BCLI do the operation I've read from ALS patients perspective they would choose CUR for effectiveness and more direct administration of cells. I am still learning the science daily (but from what I've read) it appears CUR's treatment will be more effective in many situations. The trial itself has alot more credibility due to more patients/location than BCLI - additionally if this works this confirms stem cells have a great effect on ALS (more upside IMO) The company itself has a pretty strong situation has a good pipeline with stroke and other strong catalysts aside from ALS. I think $5-$6 is a very fair place where we will end up a week after release. However I do think the market responds very, very strongly to incurable diseases such as ALS/parkinsons etc. That is my primary reason for thinking we could see high for short term. IF we do see the spike above $6 I would probably sell 80% of position (only for a few days). I will want to get back in for other catalysts. Will be in this stock for a while just not massive position I have now. In the end its all how the market feels about the data not a model - that's the first thing I learned about Bio Tech . I think that is a fair TP Jckrdu if we get a the no response to those questions. GLTA!
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Post by jckrdu on Feb 15, 2015 17:00:55 GMT
It's also possible that CUR applied for Breakthrough Designation based in the Phase 2 results that - according to one of Yelk's prior posts - was locked on July 30th and sent to the FDA in August of 2014.
Dr. Feldman is a big believer in the data, so I think its possible CUR applied for Breakthrough Designation last summer or fall based on the Phase 2 data.
In terms of overall movement of the pps...
Near-term - I think the pre-data release run-up has farther to go. I think CUR will be trading in the $4s sometime over the next 1-2 weeks.
Longer-term - Agree with Yelk that the results will be good, but some subset of patients won't respond... which may put meeting the primary efficacy endpoint at risk. I think they'll state that they know the target patient population that will see great results, and that'll help with the Phase 2b. IMO, the PPS direction after the results are announced will have as much to do (or more to do) with the timeframes they do or don't guide; Will Phase 2B be pivotal? Did they apply for Breakthrough Designation? If we find out the answer to both those 2 questions are "No" - indicating a Phase 3 will be needed - then I don't see this spiking much higher than $5-$6ish even on great results.
China stroke results/guidance on early commercialization in China is the wildcard.
I've read the blog of 3 of the patients from P2 trial so we know it does do something. It all depends on the results. If 2/3 of the patients respond very well I think we could peak at $8-$9 (not hold but peak). Will probably go to $5-$6 between news and next trial run-up. The science behind how CUR and BCLI do the operation I've read from ALS patients perspective they would choose CUR for effectiveness and more direct administration of cells. I am still learning the science daily (but from what I've read) it appears CUR's treatment will be more effective in many situations. The trial itself has alot more credibility due to more patients/location than BCLI - additionally if this works this confirms stem cells have a great effect on ALS (more upside IMO) The company itself has a pretty strong situation has a good pipeline with stroke and other strong catalysts aside from ALS. I think $5-$6 is a very fair place where we will end up a week after release. However I do think the market responds very, very strongly to incurable diseases such as ALS/parkinsons etc. That is my primary reason for thinking we could see high for short term. IF we do see the spike above $6 I would probably sell 80% of position (only for a few days). I will want to get back in for other catalysts. Will be in this stock for a while just not massive position I have now. In the end its all how the market feels about the data not a model - that's the first thing I learned about Bio Tech . I think that is a fair TP Jckrdu if we get a the no response to those questions. GLTA! Good thoughts Yelk. ALS gets a lot of national attention (ice bucket challenge) ... so these results may put CUR in the limelight.
Predicting how high the pps will spike is almost impossible to do, as we all know as there are so many variables. Great Phase 2 results where the primary endpoint was met + news of either a pivotal Phase 2b or Breakthrough Designation award.... then yeah, I can see this hitting $8-$9 on that news.
When I think about spikes, I consider market CAP. CUR has almost 90 million shares issued, so a $9 pps would be a market CAP of $810 million. Possible I suppose, but I don't think that level would hold if Phase 2b isn't pivotal.
(On the recent spikes of BCLI and ADXS, note that those 2 companies had tiny floats... so their sharp spikes higher were more expected IMO. Just wanted to mention that as the size of the float does impact the level of the spike seen on good news.)
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Post by lcd on Feb 15, 2015 17:35:41 GMT
I agree jckrdu. I can't see a market cap of much over $600 million holding unless they bring in some news from China or clear guidance on a pivotal P2 study but I will certainly be happy to take some profits after doubling the market cap from last week's highs.
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Post by Yelk on Feb 15, 2015 17:37:22 GMT
I've read the blog of 3 of the patients from P2 trial so we know it does do something. It all depends on the results. If 2/3 of the patients respond very well I think we could peak at $8-$9 (not hold but peak). Will probably go to $5-$6 between news and next trial run-up. The science behind how CUR and BCLI do the operation I've read from ALS patients perspective they would choose CUR for effectiveness and more direct administration of cells. I am still learning the science daily (but from what I've read) it appears CUR's treatment will be more effective in many situations. The trial itself has alot more credibility due to more patients/location than BCLI - additionally if this works this confirms stem cells have a great effect on ALS (more upside IMO) The company itself has a pretty strong situation has a good pipeline with stroke and other strong catalysts aside from ALS. I think $5-$6 is a very fair place where we will end up a week after release. However I do think the market responds very, very strongly to incurable diseases such as ALS/parkinsons etc. That is my primary reason for thinking we could see high for short term. IF we do see the spike above $6 I would probably sell 80% of position (only for a few days). I will want to get back in for other catalysts. Will be in this stock for a while just not massive position I have now. In the end its all how the market feels about the data not a model - that's the first thing I learned about Bio Tech . I think that is a fair TP Jckrdu if we get a the no response to those questions. GLTA! Good thoughts Yelk. ALS gets a lot of national attention (ice bucket challenge) ... so these results may put CUR in the limelight.
Predicting how high the pps will spike is almost impossible to do, as we all know as there are so many variables. Great Phase 2 results where the primary endpoint was met + news of either a pivotal Phase 2b or Breakthrough Designation award.... then yeah, I can see this hitting $8-$9 on that news.
When I think about spikes, I consider market CAP. CUR has almost 90 million shares issued, so a $9 pps would be a market CAP of $810 million. Possible I suppose, but I don't think that level would hold if Phase 2b isn't pivotal.
(On the recent spikes of BCLI and ADXS, note that those 2 companies had tiny floats... so their sharp spikes higher were more expected IMO. Just wanted to mention that as the size of the float does impact the level of the spike seen on good news.)
Agreed - why don't we settle for $6 and if it flies by then we can be pleasantly surprised otherwise be ready . I still can't believe how good P1 data is. Quote: "There's no better evidence of NSI-566 working than looking at the results of the three patients in the final cohort (cohort #5) of the Phase 1 trial. These were the highest dosed patients who received both lumbar and cervical injections. Long-term follow-up analyses of these patients suggest disease stabilization three years since their initial surgery. For ALS, a disease that kills 50% of patients at two years post diagnosis and has a three-year survival rate of less than 30% (Forbes, RB et al., 2004), results of Neuralstem's Phase 1 are outstanding." My thoughts on this data: Cells 500,000 - locations less. These patients showed stabilization for more cells/locations than others in P1. In P2 16 million cells and in blogs some patients say they actually greatly improved which I see some of here but not nearly as much as I read. One of the patient blogs I read she could barley do anything, now 1-2 years after surgery she gets in and out of bed on her own and can move around. To me this comparison between the 2 sections of P1 cohort and these results of P2 patients demonstrates a direct link between injection location/cell amount. I still think 1/3 or so may not respond very well but I do think we will see not only stabilization but maybe 20% of patients could show improvement. This is why we have no idea where PPS will go. In BCLI we saw many words about slowing progression but not much mention of stabilization long term data or great improvement. Attachments:
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Post by Yelk on Feb 15, 2015 21:59:00 GMT
We already have efficacy data from the patients directly on how there tests for the trial are going. For anyone who is interested blog patient #1 about 7-8 million cells. I was a little confused why these patients didn't receive the 20 million my DD showed - I think I was incorrect and only the last patients in June got 20 million. Shows stabilization: Posted Jan 2015: www.kregpalkoals.com/2015/01Last week, I had my 6 month post-operation testing. I tested relatively well. Although the surgery set me back a fair bit, I have remained pretty stable for the last 7 months. My legs are about all I have left. Lifted out of my chair and with a bit of support, I can stand for a couple minutes. Although I can move my legs and ride a recumbent bike, I am unable to walk on my own anymore, as my upper body remains too weak to support a walker now.
My breathing capacity remains incredibly strong. Last week, I tested/blew in the 93% range for healthy people in my age bracket! This is good news, as failure of breathing function is the main cause of death for most people with ALS. Most notably, the main goal of my stem cell transplant was to preserve my breathing. For now, that aspect seems to be working.This patient didn't show vast improvement but more of the outcome of stabilization we were looking for from P1. Another Patient, April. Posted May 2014: aprilals.com/I received 4,000,000 stem cells directly into my cervical spinal cord. This is the best place as far as survival because the hope is it affects the diaphragm muscles which keeps you breathing on your own if they have improved strength. My breathing has improved some.
I want to share something new. I’ve been taken by surprise by my leg strength improvement. This has shown true by testing, it’s certainly not just a feeling. I wasn’t expecting this great benefit. I walk some with my walker during my daily range of motion exercises, but no easy stroll by any means, also a short distance. My right leg especially has been very weak leaving me to compensate with upper body strength, mainly left side, It hasn’t come easy or wasn’t safe for any real distance. The leg strength came on very unexpectedly Posted August 2014: I want to share my last Emory, nine month, post operative results. Again great news! I’m holding steady. I did hope and believe my breathing score would be a little higher, but it’s still at pre-surgery baseline and I was steadily declining. Even though I do have mild slurring, my voice is still stronger than pre-surgery. I still feel that my right wrist is slowly going back down, but I’m still above pre-surgery, so I’m not complaining. Both legs are still a bit stronger even though my right is pretty weak. I’m still not walking any real distance with my walker and having lots of joint pain and a feeling of broken bones in my feet when I do. I’m so thankful for my strong left leg that keeps me more independent by being able to transfer. I don’t think I’ve mentioned before that I’ve been having trouble sitting up in bed for any length of time. before I know it I’m all the way on my back. My left leg really serves me here. I park my power chair close and midway up the bed. I brace myself with my foot on it and push myself back up. I have a body pillow to put in front of my sit bones and I can pretty much keep myself up on my own. Sometimes I get in a situation and can use a little help from my husband. The things that cause me the most problems are my weak core muscles and my rear deltoid muscles. These are what cause me to slide down and have such a hard time getting back up with my arms. So thankful for that left leg and the improved and prolonged strength the procedure gave me. There is no doubt in my mind I’ve been given better and longer quality of life because of being in this trial. I’m so thankful! I’m also thrilled to learn there will be a phase 2b trial coming right on the heels of this. I can’t wait for the official report for this trial and really excited about the next with more than twice the patients to have the opportunity to benefit and prove the efficacy of what I now refer to, from my experience, an actual treatment for ALS. There will be hurdles to overcome with it being an invasive surgery instead of a pill. It can be done. I thank the phase 1 participants for being willing to take this first ever risk. With some of the fear of the unknown taken away, I’ll forever be grateful to be in phase II.Posted Jan 2015: I have some difficult losses that I don’t foresee ever getting back. I can’t walk. Let me mention I wasn’t one of the three in this study to get lumbar injections as well as cervical, which isn’t meant to help the legs. Guess what? I did have some very unexpected strength improvement in my legs. I have a stronger left leg giving me the ability to transfer. This is something people with more extreme muscle loss and paralysis can’t do. I could do this with my left leg before surgery although it was steadily declining. My legs are also where I’m losing what I gained faster. I was still given more time with this. Trust me, ask anyone with ALS who has lost the ability to transfer on their own just what a big deal this is. It’s not perfect for me. It’s best if I can transfer from certain angles and sides, but I haven’t fallen yet.
I can only speak for the stem cells I received in my cervical spinal cord that are from Neuralstem inc. It’s been 14 months now. I know without a doubt I would be much further progressed without them. This isn’t just my belief. It is clinically documented. The clinical data of the study results are supposed to be published by the end of January. I’ve read a phase III trial will begin shortly with more participants. I wish we could skip it and go on to have this available to all. There are people still living with improvements, time and quality of life, since phase I. This should be available now!There is another blog out there I believe as well. I'd like to note she only got 4 million and only spinal. I look forward to seeing 20 million, 10 spinal and 10 neck. GLTA holders hope this makes you more comfortable for the runup.
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Post by jckrdu on Feb 16, 2015 1:16:44 GMT
We already have efficacy data from the patients directly on how there tests for the trial are going. For anyone who is interested blog patient #1 about 7-8 million cells. I was a little confused why these patients didn't receive the 20 million my DD showed - I think I was incorrect and only the last patients in June got 20 million. Shows stabilization: Posted Jan 2015: www.kregpalkoals.com/2015/01Last week, I had my 6 month post-operation testing. I tested relatively well. Although the surgery set me back a fair bit, I have remained pretty stable for the last 7 months. My legs are about all I have left. Lifted out of my chair and with a bit of support, I can stand for a couple minutes. Although I can move my legs and ride a recumbent bike, I am unable to walk on my own anymore, as my upper body remains too weak to support a walker now.
My breathing capacity remains incredibly strong. Last week, I tested/blew in the 93% range for healthy people in my age bracket! This is good news, as failure of breathing function is the main cause of death for most people with ALS. Most notably, the main goal of my stem cell transplant was to preserve my breathing. For now, that aspect seems to be working.This patient didn't show vast improvement but more of the outcome of stabilization we were looking for from P1. Another Patient, April. Posted May 2014: aprilals.com/I received 4,000,000 stem cells directly into my cervical spinal cord. This is the best place as far as survival because the hope is it affects the diaphragm muscles which keeps you breathing on your own if they have improved strength. My breathing has improved some.
I want to share something new. I’ve been taken by surprise by my leg strength improvement. This has shown true by testing, it’s certainly not just a feeling. I wasn’t expecting this great benefit. I walk some with my walker during my daily range of motion exercises, but no easy stroll by any means, also a short distance. My right leg especially has been very weak leaving me to compensate with upper body strength, mainly left side, It hasn’t come easy or wasn’t safe for any real distance. The leg strength came on very unexpectedly Posted August 2014: I want to share my last Emory, nine month, post operative results. Again great news! I’m holding steady. I did hope and believe my breathing score would be a little higher, but it’s still at pre-surgery baseline and I was steadily declining. Even though I do have mild slurring, my voice is still stronger than pre-surgery. I still feel that my right wrist is slowly going back down, but I’m still above pre-surgery, so I’m not complaining. Both legs are still a bit stronger even though my right is pretty weak. I’m still not walking any real distance with my walker and having lots of joint pain and a feeling of broken bones in my feet when I do. I’m so thankful for my strong left leg that keeps me more independent by being able to transfer. I don’t think I’ve mentioned before that I’ve been having trouble sitting up in bed for any length of time. before I know it I’m all the way on my back. My left leg really serves me here. I park my power chair close and midway up the bed. I brace myself with my foot on it and push myself back up. I have a body pillow to put in front of my sit bones and I can pretty much keep myself up on my own. Sometimes I get in a situation and can use a little help from my husband. The things that cause me the most problems are my weak core muscles and my rear deltoid muscles. These are what cause me to slide down and have such a hard time getting back up with my arms. So thankful for that left leg and the improved and prolonged strength the procedure gave me. There is no doubt in my mind I’ve been given better and longer quality of life because of being in this trial. I’m so thankful! I’m also thrilled to learn there will be a phase 2b trial coming right on the heels of this. I can’t wait for the official report for this trial and really excited about the next with more than twice the patients to have the opportunity to benefit and prove the efficacy of what I now refer to, from my experience, an actual treatment for ALS. There will be hurdles to overcome with it being an invasive surgery instead of a pill. It can be done. I thank the phase 1 participants for being willing to take this first ever risk. With some of the fear of the unknown taken away, I’ll forever be grateful to be in phase II.Posted Jan 2015: I have some difficult losses that I don’t foresee ever getting back. I can’t walk. Let me mention I wasn’t one of the three in this study to get lumbar injections as well as cervical, which isn’t meant to help the legs. Guess what? I did have some very unexpected strength improvement in my legs. I have a stronger left leg giving me the ability to transfer. This is something people with more extreme muscle loss and paralysis can’t do. I could do this with my left leg before surgery although it was steadily declining. My legs are also where I’m losing what I gained faster. I was still given more time with this. Trust me, ask anyone with ALS who has lost the ability to transfer on their own just what a big deal this is. It’s not perfect for me. It’s best if I can transfer from certain angles and sides, but I haven’t fallen yet.
I can only speak for the stem cells I received in my cervical spinal cord that are from Neuralstem inc. It’s been 14 months now. I know without a doubt I would be much further progressed without them. This isn’t just my belief. It is clinically documented. The clinical data of the study results are supposed to be published by the end of January. I’ve read a phase III trial will begin shortly with more participants. I wish we could skip it and go on to have this available to all. There are people still living with improvements, time and quality of life, since phase I. This should be available now!There is another blog out there I believe as well. I'd like to note she only got 4 million and only spinal. I look forward to seeing 20 million, 10 spinal and 10 neck. GLTA holders hope this makes you more comfortable for the runup. Thanks for posting Yelk. Those blogs are tough to read... your heart really goes out to these patients. Hoping for some strong Phase 2 results that gives these people even more hope.
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Post by Yelk on Feb 16, 2015 3:53:20 GMT
Yes it is difficult. As I mentioned before my uncle died from ALS and I witnessed the whole thing. Was one of the most active people I know and a fantastic person. His son and I are still friends. I really hope this turns out to be beneficial. Forgive the post spamming but I'm thinking out loud and you guys are more than welcome to agree/disagree with any of my DD thoughts. I went over the presentation one last time. Regarding the bold. RE Feb 2015 webcast www.veracast.com/webcasts/bio/ceoinvestor2015/68122195901.cfm" This is open label non blinded trial, we already know the results are encouraging. It is Important to understand what we are trying to accomplish and learn from the second trial and what we think we've learned from the first trial. Why do we get good results with some and not others? Take home from first teds group did better - also the otherwise healthy and got the most cells." " Where we put the cells matters." I find this to be a very bold statement that the results will be "as expected". Because the focus isn't on improvement at this point (I think the next trial will be) we may not see a massive spike on data day. I do however think these statements at the very least mitigate risk and give us a sense of direction. Garr is trying to articulate to us that we won't go from flat-line to increasing health overall, rather maybe the patients that were given 20 injections with max cells show better results than the other patients. This would confirm the P1 trial and would give direction for P2b to try for efficacy of a high number of patients and maybe possible improvement for a few. I'm worried the market won't react "overly" positive because of this however I do think it will be positive and that's what matters. There will be much more hype as we move along striving for signs of improvement from flat line - although IMO flat line is improvement. Another thing that we went over already is stroke. I'd like to point out it was shown visually the data would be released Q1. We have been in Q1 for 2/3 months at near point for ALS data. This means stroke data will be either directly before or directly after as it could be as late as March for ALS data. Something to consider. I have no clue how positive/negative data will affect the stock. All I will say if it happens before ALS data and is negative load up on the spike down... I'd like to note that I think this was a slide error and it will be more summertime maybe?? I hadn't really gone over the pipeline as I was so taken up in stroke but man we are loaded with catalysts... Pipeline to look forward to:Major Depression: P2 starting in April 2015 (maybe later) Schizophrenia: Start P1b (not for sure) this summer (July 2015) >>>1Q 2016 Stroke: Finish P1/2 this quarter. Pivotal trial >>>2017. Chronic spinal chord: Finish enrollment this quarter. 6 months observation period (August 2015) Acute spinal cord: Not yet approved. Trial will start this year. Alzheimer's: Pre-clinical and a year away. Animal efficacy ongoing 2015/2016.
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Post by Yelk on Feb 16, 2015 4:21:14 GMT
Can you please link where you found Dec 2015 due for Stroke trial? And do we know if P1 data due at the same time? I've been searching over an hour trying to find data release estimation. I'm conflicted because original January presentation said: Expected duration: approximately two years, combined Phase I/II study, including patient monitoring and data collection which aligns with your date - however is has been escalated now. It looks like data will be released at the same time for P1/P2. Considering the pivotal trial is starting later this year we can assuredly expect data soon for P1/P2... I'm sure you are all aware of the stroke leak data (assuming its legit) smithonstocks.com/neuralstem-some-encouraging-but-very-early-information-on-chinese-ischemic-stroke-trial-using-nsi-566-stem-cells-cur-buy-2-59/
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Post by dayanand33 on Feb 16, 2015 19:59:49 GMT
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Post by jckrdu on Feb 17, 2015 14:54:01 GMT
I like the 3 month chart. I like the 1 year chart even better... looks fairly bullish. On the 1 year chart you can see the recent move higher and consolidation happening over the last few months in the $3.30ish range.... the trading range has continued to get tighter over time. Looking like a breakout is getting ready to happen to somewhere over $3.50... we'll see. Nice to see shares traded over $3.50. Hopefully it holds and we keep moving higher.
Two recent but very small gaps in the CUR chart; $3.20 to $3.24 and $3.41 to $3.43. I'm not considering those small gaps as factors given CUR is so close to announcing results.
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Post by lovie350z on Feb 17, 2015 15:07:03 GMT
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Post by Yelk on Feb 17, 2015 15:12:03 GMT
Looks like its not ready to pass that 3.50-3.60 mark yet.
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Post by jckrdu on Feb 17, 2015 15:21:05 GMT
Looks like its not ready to pass that 3.50-3.60 mark yet. Very heavy volume in the first hour. Let's see if that pace is maintained.
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Post by Yelk on Feb 17, 2015 20:39:05 GMT
Looks like its not ready to pass that 3.50-3.60 mark yet. Very heavy volume in the first hour. Let's see if that pace is maintained. Yeah you can see the resistance line at 3.59 it has to break. It tried but had no support. Maybe by the end of the week we can pass it.
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Post by forthefuture on Feb 18, 2015 0:55:20 GMT
Yes it is difficult. As I mentioned before my uncle died from ALS and I witnessed the whole thing. Was one of the most active people I know and a fantastic person. His son and I are still friends. I really hope this turns out to be beneficial. Forgive the post spamming but I'm thinking out loud and you guys are more than welcome to agree/disagree with any of my DD thoughts. I went over the presentation one last time. Regarding the bold. RE Feb 2015 webcast www.veracast.com/webcasts/bio/ceoinvestor2015/68122195901.cfm" This is open label non blinded trial, we already know the results are encouraging. It is Important to understand what we are trying to accomplish and learn from the second trial and what we think we've learned from the first trial. Why do we get good results with some and not others? Take home from first teds group did better - also the otherwise healthy and got the most cells." " Where we put the cells matters." I find this to be a very bold statement that the results will be "as expected". Because the focus isn't on improvement at this point (I think the next trial will be) we may not see a massive spike on data day. I do however think these statements at the very least mitigate risk and give us a sense of direction. Garr is trying to articulate to us that we won't go from flat-line to increasing health overall, rather maybe the patients that were given 20 injections with max cells show better results than the other patients. This would confirm the P1 trial and would give direction for P2b to try for efficacy of a high number of patients and maybe possible improvement for a few. I'm worried the market won't react "overly" positive because of this however I do think it will be positive and that's what matters. There will be much more hype as we move along striving for signs of improvement from flat line - although IMO flat line is improvement. Another thing that we went over already is stroke. I'd like to point out it was shown visually the data would be released Q1. We have been in Q1 for 2/3 months at near point for ALS data. This means stroke data will be either directly before or directly after as it could be as late as March for ALS data. Something to consider. I have no clue how positive/negative data will affect the stock. All I will say if it happens before ALS data and is negative load up on the spike down... I'd like to note that I think this was a slide error and it will be more summertime maybe?? I hadn't really gone over the pipeline as I was so taken up in stroke but man we are loaded with catalysts... Pipeline to look forward to:Major Depression: P2 starting in April 2015 (maybe later) Would be great to get it going but I wonder who will fund it. UCSD funded the 1b trial.Schizophrenia: Start P1b (not for sure) this summer (July 2015) >>>1Q 2016 In the presentation, he seemed a little iffy on this timeline. Garr has a history of playing it a little loose with his timeframes so I wouldnt be surprised to see it slip to 2H15. Either way, it's such an early stage trial, I don't think that will impact the share price too much.Stroke: Finish P1/2 this quarter. Pivotal trial >>>2017. Data could be huge here. I'm trying to keep my expectations low considering it's a phase 1, but I can't help but to think how transformative this could be. I hope we get data in Q1, but considering they're still enrolling this quarter, it'll take some time to evaluate, and if neutral to positive, they'll probably want to present it at a conference. The American Academy of Neurology annual conference is mid-April, which may be a good venue.Chronic spinal chord: Finish enrollment this quarter. 6 months observation period (August 2015) Including data review time, I think likely a Q4 catalyst.Acute spinal cord: Not yet approved. Trial will start this year. This has been in pending approval status for about 2 years. Wouldn't hold my breath.Alzheimer's: Pre-clinical and a year away. Animal efficacy ongoing 2015/2016. Thought I'd add some of my thoughts above Regarding the ALS trial, I agree with you guys. Sounds like subpopulation efficacy will be key here. IMO, the determinant of how it goes is how effective it is in that subpopulation and how large that subpopulation is. If it does exceptionally well in non-bulbar patients, I think we could see it hold at +50% from here. FWIW, CUR has been pretty good at capitalizing on opportunities to raise cash. Just something to be aware of. They're at the point now though, where I'd really like to see them partner something out for NSI-189. They're at a stage where they should really start to be thinking about marketing, distribution, sales, etc.
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Post by jckrdu on Feb 18, 2015 12:46:20 GMT
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Post by jckrdu on Feb 18, 2015 12:54:57 GMT
Tweet from Jason Napadano
"Jonathan Aschoff at Brean usually hates everything, and is right. He initiated $CUR today with a BUY and $8 target."
Hopefully this generates a little more buying pressure today and we take the next leg up. Not many more trading days left to "late February" when news could be released, so some high volume trading days should be with us over the next week or so.
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