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Post by jckrdu on Feb 11, 2015 1:01:11 GMT
I recently got in as well. I am of course hoping for great results but as a stockholder I'm not sure if I should sell before or after the results. Often seems before is the more optimal time.. thoughts? I'm thinking the exact same thing actcfan. If you look back at the 10 or so companies this board has tracked over the last year that have had a significant data release, I'm pretty sure you would have been better selling prior to data release (Ex: ACTC/OCAT, BCLI, ONCS, NRIFF, ATHX w/ UC data, etc.). All had exceptional moves up prior to the data release, followed by a sharp move down when the data was actually released. I don't think I'm going to allow myself to hold 100% through a data release again in my life, unless 1.) I am near certain the data will be a (positive) surprise (although I did feel this way about ACTC/OCAT and got burned) OR 2.) my position is small enough that I can live with a ~50% loss. With CUR, I'm likely going to be selling 1/2 before and 1/2 after, but obviously things can change from now until then. Best of luck to all! Agree with selling some before and maybe holding some through results.
CUR is announcing Phase 2 results for ALS, and will then be using those results to design and run a follow-on Phase 2b trial. So, they're not going from Phase 2 results directly to a Phase 3 trial... or like ATHX from Phase 2 to potential commercialization. Those facts will be guiding some of my decisions on when to take profits on CUR and move back into ATHX.
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Post by Yelk on Feb 11, 2015 2:24:09 GMT
I am weighted very heavy right now. Will probably sell majority position Feb 26 Eve depending on chart and hold a meaningful position through to mid march. I haven't seen any TP for after positive release though so at this time I'm trying to do risk/reward profile. Has anyone seen what TP would look like with positive results? I've heard double so that would be about $6.50. I haven't found any solid/specific estimations.
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Post by forthefuture on Feb 11, 2015 3:01:25 GMT
I am weighted very heavy right now. Will probably sell majority position Feb 26 Eve depending on chart and hold a meaningful position through to mid march. I haven't seen any TP for after positive release though so at this time I'm trying to do risk/reward profile. Has anyone seen what TP would look like with positive results? I've heard double so that would be about $6.50. I haven't found any solid/specific estimations. Depends on how good the data looks. The better it looks compared to BCLI, the higher it goes.
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Post by jckrdu on Feb 11, 2015 3:15:29 GMT
I got a chance to listen to the full webcast. Looks good. I like to analyze these CEO's when they present to try and get a hint of what they think of data. Maybe I'm being overly cautious but there was one line in there I didn't like. He basically said: "I want to really express what we are trying to achieve in this study" I've seen this phrase a lot to soften the blow of bad data.
Now I really read ALOT into that. I am still fully leaning towards positive data due to DD on science, BCLI success, others opinions, DR. EVA's presentation, recent comments on presentations and most importantly patients blogs from this trial. ^ That is alot more convincing than one line - also I don't know this CEO very well. GLTA I think we can expect to see Data as early as the end of February! I intend to hold a meaningful position right through the data. My thoughts in response to the bolded after listening to the call...
When he made that statement, he was reviewing the goals of this trial. One of the goals listed was to determine why some patients responded and others didn't. That was the bullet he was speaking to when he made the above bolded comment. So, based on that, my belief is that while the results will likely be very good (based on all the other DD here) there will likely be some patients that did not respond. While that may seem like a negative, the CEO's point was that it'll help them identify patients who will respond... to ensure the success of the next trial.
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Post by jckrdu on Feb 11, 2015 21:06:03 GMT
A little surprised by the lack of follow thru on the volume today... almost 3 times as much volume yesterday. One would think that selling pressure will continue to decrease and buying pressure will continue to increase prior to results, which should be out over the next 2-4 weeks.
I think there's still a gap in the chart from $3.20 to $3.25 from 2 days ago... it was partially filled today.
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Post by Yelk on Feb 12, 2015 14:49:11 GMT
Well - fasten your seat-belts. If there is one thing I've learned about this stock in the short time I've been in it is that it has a mind of its own. We may see further decline for no reason and a massive spike last week and a half of Feb. I am pretty bullish for Friday.
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Post by jckrdu on Feb 12, 2015 15:48:16 GMT
Well - fasten your seat-belts. If there is one thing I've learned about this stock in the short time I've been in it is that it has a mind of its own. We may see further decline for no reason and a massive spike last week and a half of Feb. I am pretty bullish for Friday. Shares for sale under $3.30 seem to be drying up.
Per the CEO, ALS Phase 2 results will be released "late February or early March".
IMO, "late February" starts Wednesday Feb 25th. So, with the markets closed on Monday the 16th for President's Day, that means after today there will be 7 trading days left until "late February".
IMO, most traders wanting to get in for the news bump will start buying over the next 7 days. Let's hope we see a spike.
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Post by jckrdu on Feb 12, 2015 17:45:44 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.
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Post by Yelk on Feb 13, 2015 14:27:15 GMT
Both CUR and BCLI seem to work like clockwork. CUR forms a horseshoe up and BCLI down everyday lol. CUR seems to have a hard time closing strong - hopefully we get some movement here upside. Like jckrdu mentioned not many trading days left so should see at least some volume.
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Post by forthefuture on Feb 13, 2015 21:07:22 GMT
Both CUR and BCLI seem to work like clockwork. CUR forms a horseshoe up and BCLI down everyday lol. CUR seems to have a hard time closing strong - hopefully we get some movement here upside. Like jckrdu mentioned not many trading days left so should see at least some volume. Not a bad day. I like the hint at increased volume. Quite a bit of resistance between 4:10 and 4.81 though.
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Post by jckrdu on Feb 13, 2015 22:45:15 GMT
Both CUR and BCLI seem to work like clockwork. CUR forms a horseshoe up and BCLI down everyday lol. CUR seems to have a hard time closing strong - hopefully we get some movement here upside. Like jckrdu mentioned not many trading days left so should see at least some volume. Not a bad day. I like the hint at increased volume. Quite a bit of resistance between 4:10 and 4.81 though. Signs of life today.
I'll be very happy to be discussing when we'll break resistance in the $4s... hopefully those discussions will be happening next week.
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Post by Yelk on Feb 14, 2015 2:37:54 GMT
Not a bad day. Looking for better though! I'm hoping we crest $5 for this right before data release but that may be overly optimistic. Historically it looks like it is definitely possible. You know it is interesting that we are as low as we are the stock rose to $4 at the simple announcement of this trial and has gone higher before on simple financial updates. I get a very strange feeling we may get a spike here out of the blue nobody is expecting as we head into march. If we do I'm getting out like 80%. Historically BCLI/CUR lose like 50% value in a very short time after any positive news because people put money elsewhere. It has nothing to do with bad news or that the company won't go anywhere - just a natural reaction. I don't think I'll be staying in right after with much. Will re-establish position right before next phase starts. Thoughts?
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Post by dayanand33 on Feb 14, 2015 13:40:08 GMT
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Post by jckrdu on Feb 14, 2015 14:23:16 GMT
Thanks Day... good information.
What are your thoughts on the next "Phase 2" trial for ALS that they stated would happen after these Phase 2 results are released. Are you thinking the next Phase 2 will be pivotal? Also a chance they announce they've applied for Break Through designation I suppose...
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Post by Yelk on Feb 14, 2015 17:04:21 GMT
I know Dr. Eva mentioned some odd things about the next trial. Like it wouldn't be blind or something. Everyone thought that was weird. Going to need to find out more before march. From the information I've gathered the CEO's thoughts are this: What we are doing works, it works well and its fantastic. There is however room for improvement as it didn't work as well as we wanted in every single patient. I thought the exactly same thing from the Doctors comments who by the way has seen data as of Feb 2, 2015 I believe if you see my comments on prior pages.
I am fully expecting positive results - the question is how positive will they be, how will the market react and how will the next trial pan out because of those results. It's been hinted at the results were good enough to start the next trial.
My hope is that the market will see where it succeeded and looking forward and not in the small parts where it didn't do miracles. The fact that it is doing anything at all is a step forward in science versus this horrible disease in my opinion compared to current treatment.
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Post by Yelk on Feb 14, 2015 17:08:11 GMT
www.youtube.com/watch?v=v5rcBLjck68 A one hour video with Dr. Eva on ALS that included some detailed comments on the phase the NSI-566 stem cells. She has been very positive on the phase 1 results. She has made essential the same comments as Dr. Glass on the phase 1 results stating that patients 10, 11 and 12 have shown stabilized disease at three years post diagnosis. She has indicated that the phase 2 trial has also produced encouraging results, but has not provided details. Enrollment in this trial was completed in July 2014 and the study should complete in early 2015. No interim results have been released to date, but Dr. Feldman has said “I wouldn’t be spending all my waking hours on writing the next phase trial, if I do not believe in the phase II data.” I would anticipate that she will present data on interim results at the American Neurological Association Annual Meeting in Baltimore from October 12 through 14. As Jason Napadano said: "There may be no larger catalyst in our coverage universe for 2015." The CEO said: "We may be commercialization as early as 2 years." Dr. Eva wrapped up with: "Phase II data was complete January 1. On February 1, I broke the data. I wanted to share it with you. It will be available, I hope, in April. I'm sorry I can't share it with you. I was asked by the Company and FDA not to share." "Invite me back in a few months." She mentioned the whole thing was "very exciting" and she has go-ahead for Phase III. Also CEO said end of Q1 early in Q2 and Eva said April. This could mean even the by the last couple days of March so keep an eye out. Bumping this post from before if anyone hasn't read - provides some insight and a movie. Hope this helps. I'm listening to the movie in the background while doing other things and its a bit long. Will let you know what I find. Some other thoughts from Seeking Alpa: In the three patients in the last safety cohort who received treatments in both the lumbar and cervical regions with the highest number of cells (100K) per injection, all showed significant slowing of the progression of the disease. One patient showed functional improvement from pre-treatment baseline. The improvement continues to the present.
In a Phase 2 dose escalation trial, investigators reached the maximum planned dose of 20 lumbar and 20 cervical injections of 400K cells each. The last of the surgeries was performed in July. The study will conclude after a six-month observation period.As Eva mentioned early in 2015 the continued progress from 3 patients in P1 data are still impressive and those patients had less then all P2 patients I believe. I think this continues to point towards positive data.
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Post by Yelk on Feb 14, 2015 18:30:07 GMT
Thanks Day... good information.
What are your thoughts on the next "Phase 2" trial for ALS that they stated would happen after these Phase 2 results are released. Are you thinking the next Phase 2 will be pivotal? Also a chance they announce they've applied for Break Through designation I suppose...
I haven't found as much as I wanted for P3 Plans but hope this helps everyone for not wanting to watch a video over an hour long My notes from the video: Initial studies:-Studies started in 2006 with rats, followed by over 105 pigs as FDA requested larger animals. All data (and I saw it looked excellent). Phase 1 Safety:-2010 First injection of stem cells into the spine in humans, objective in P1 trial was safety -The FDA was pleased the cells don't migrate far -P1 consisted on 12 lumber and 6 cervical, 3 of which had lumber as well for a double dose, this trial was maximum of 500,000 stem cells -The 3 patients did extraordinarily well, however at P1 does not prove much as it could be lesser ALS disease vs good stem cell reaction -The disease affects large motor neurons which is why you must be treated in under 2 years, most commonly after 2 years these will be dead, the objective of stem cells is to help keep these large motor neurons healthy. Age 18-70. -Patients with initial weakness in arms and legs respond the best, patients within the brain will continue to decline at a steady rate -2/3 of patients show an almost non-decline level (near flat in my opinion) disease progression. I was very impressed by this P1 data, Jason Napodano had mentioned but I didn't look at it much -Was a little frustrating for company and patients as this was a safety study not efficacy -The patients treated had much better function and those that couldn't walk were able to walk back into the clinic -1 Patient responded so well he has been asking to have the operation numerous times now (We can't prove this to be stem cells for 1 patient) but encouraging nonetheless. -Statistically 1/3 of patients that continue decline are due to the brain area loss and not limbs/spinal. Phase 2: Efficacy-30 patients, data was locked July 30 and sent to FDA August expected Feb, 2015 (Update we have now been told end of Feb/Early march) -20 total injections, 10 into neck and 10 spinal totaling 16 million (note the significant boost from 500,000) -Endpoints: Looking for 60% to show great respiratory function to go to P3 The surgery (actual video of it): -Bones removed to see the spine better -Covering removed on-top of spinal fluid -Stem cells injected, machine moves with patients breathing/movement -Sown up sections and skin stapled -Patients are on non narcotic pain killers for 7-10 days (no patients have asked for further medication beyond this point) -Admitted on Wednsday and always leave Saturday Phase 3:-45 Patients -Will be discussing details ASAP after release of data for this last P2 trial My conclusion: As posted prior all this indicates that we will see positive data but can also expect to see roughly 1/3 patients not responding as well as we would like. Nevertheless with the focus on efficacy, impressive P1 results with 500,000 cells compared to 16 million and injecting more locations I think we can expect to see even better data. Why? Not just the amount of cells but the location. The Dr described how each location matters as we are trying to salvage large motor neurons. Affecting some neurons helped but helping almost all? I look forward to the data and expect it to be phenomenal for some patients even more so than P1 and 30% or so unresponsive. After this further DD I will probably hold a lot more through data than originally planned.
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Post by forthefuture on Feb 14, 2015 22:27:48 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).
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Post by Yelk on Feb 14, 2015 22:45:04 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). I was a little bit confused on that front as the company keeps calling it P3 but 2b would make more sense. Just quoting here. Also I believe you are right about the stroke commercialization over the ALS. There are rumors they may use it in army hospitals in China. In this detailed post (near the bottom) it is also called P3 smithonstocks.com/neuralstem-dr-eva-feldmans-latest-presentation-on-the-use-of-curs-stem-cells-in-als-cur-buy-4-04-paid-subscribers-only/I can link numerous different sites and sources that calls the next trail starting for CUR ALS P3 in 1H 2015. Can someone shed some light on this over 2b? Topic 3: Phase III ALS Trial Design At yesterday's RIRC 2015 Symposium Dr. Feldman mentioned that (a) Phase II results warranted a Phase III; and (b) that she had received "the go-ahead" for Phase III.
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Post by dayanand33 on Feb 15, 2015 0:02:25 GMT
Thanks Day... good information.
What are your thoughts on the next "Phase 2" trial for ALS that they stated would happen after these Phase 2 results are released. Are you thinking the next Phase 2 will be pivotal? Also a chance they announce they've applied for Break Through designation I suppose...
Dr Eva's presentation from August contains some really useful information www.youtube.com/watch?v=v5rcBLjck68It is a long one so you may want to jump directly to 34.55 mins till 41:30 min The tone is one of of guarded optimism. The next trial is intended to measure efficacy. No mention of it being pivotal. If they are indeed two years from commercialization then it ought to be pivotal. But it has not been stated explicitly anywhere. Slide # 11 of corporate presentation states the following U.S. Phase II Concluded Final Surgeries in July 2014; Subsequent 6-Month Observation Period • Goal: maximum safe tolerated dose; evaluate efficacy for clinical proof-of-concept to advance toPhase II/III trial investor.neuralstem.com/index.php?s=126&item=143 I would also like to mention that they have a wild card in hand with the china Phase II stroke results that are due in Dec 2015. There was some news leak from an unknown source 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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