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Post by jckrdu on Jul 15, 2014 0:31:12 GMT
All, Link to the Athersys thread on Google is below. Let's continue the discussion here. So, I'm looking for the PR stating that stroke enrollment has been completed.... probably sometime in August/September IMO. That PR should give us an idea on when to expect Phase 2 stroke results. jck Athersys Discussion on Google Board |
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Post by selluwud on Jul 15, 2014 0:49:53 GMT
I'm in at 1.67 and holding for the next move up on stroke trial data. Probably will sell a third on the build up as a hedge.
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Post by dayanand33 on Jul 15, 2014 12:55:44 GMT
Some naive doubts about inclusion criteria of the patients. Per my understanding these cells need to be injected into the spleen within a couple of days after a heart attack. The event of an heart attack is obviously unpredictable. I presume they cannot select the trial patients in advance, unlike other diseases. So how do they choose patients? Is it that when a person with a heart attack is admitted to ICU, a consent is sought to administer the cells in the spleen?
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Post by selluwud on Jul 15, 2014 12:59:23 GMT
Some naive doubts about inclusion criteria of the patients. Per my understanding these cells need to be injected into the spleen within a couple of days after a heart attack. The event of an heart attack is obviously unpredictable. I presume they cannot select the trial patients in advance, unlike other diseases. So how do they choose patients? Is it that when a person with a heart attack is admitted to ICU, a consent is sought to administer the cells in the spleen? Do you mean "Stroke"? |
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Post by jckrdu on Jul 15, 2014 12:59:56 GMT
Some naive doubts about inclusion criteria of the patients. Per my understanding these cells need to be injected into the spleen within a couple of days after a heart attack. The event of an heart attack is obviously unpredictable. I presume they cannot select the trial patients in advance, unlike other diseases. So how do they choose patients? Is it that when a person with a heart attack is admitted to ICU, a consent is sought to administer the cells in the spleen? Phase 2 acute micardial infraction (heart attack) trial has not been announced but should be in 2014. Not sure how the cells were administered in the Phase 1 AMI trial, but I don't think they were injected into the spleen. For the stroke trial, the cells are not injected into the spleen... they're given by a standard IV. |
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Post by jckrdu on Jul 15, 2014 13:02:51 GMT
Some naive doubts about inclusion criteria of the patients. Per my understanding these cells need to be injected into the spleen within a couple of days after a heart attack. The event of an heart attack is obviously unpredictable. I presume they cannot select the trial patients in advance, unlike other diseases. So how do they choose patients? Is it that when a person with a heart attack is admitted to ICU, a consent is sought to administer the cells in the spleen? Phase 2 acute micardial infraction (heart attack) trial has not been announced but should be in 2014. Not sure how the cells were administered in the Phase 1 AMI trial, but I don't think they were injected into the spleen. For the stroke trial, the cells are not injected into the spleen... they're given by a standard IV. There's also a bit of good information on the ATHX website on how they select the stroke patients. Basically, they strive to inject within 48 hours after the stroke. They also talk about being able to identify stroke patients that are more likely to recover on their own, and exclude those people from the trial. |
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Post by dayanand33 on Jul 15, 2014 14:55:02 GMT
Thanks jckrdu, Sorry- my bad. I mixed up between stroke and heart attack. I mistakenly assumed the cells are injected in the spleen. Just after stroke, spleen releases inflammatory cells that cause further damage. Multistem cells aim to reduce this inflammatory response by acting on spleen. For those who are interested in knowing more, the ceo's interview is very informative seekingalpha.com/article/2233643-athersys-down-but-not-out-an-interview-with-ceo-van-bokkelen |
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Post by selluwud on Jul 17, 2014 19:20:55 GMT
ATHX has dipped to 1.50 today, can it go lower?? Waiting and watching.
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Post by jckrdu on Jul 17, 2014 19:39:16 GMT
ATHX has dipped to 1.50 today, can it go lower?? Waiting and watching. Not sure. If they announce a delay to completing stroke enrollment and push out the results from end to 2014 to 2015, that'll certainly put downward pressure on the stock. Conference call schedule for early August. Should get an update then. |
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Post by forthefuture on Jul 17, 2014 21:29:55 GMT
ATHX has dipped to 1.50 today, can it go lower?? Waiting and watching. Bad time to be in small cap biotech with Yellen making the statements she made the other day targeting the sector as a whole. Good luck to ATHX holders, but that chart looks nasty, IMO. |
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Post by jckrdu on Aug 3, 2014 13:57:18 GMT
ATHX has dipped to 1.50 today, can it go lower?? Waiting and watching. Not sure. If they announce a delay to completing stroke enrollment and push out the results from end to 2014 to 2015, that'll certainly put downward pressure on the stock. Conference call schedule for early August. Should get an update then. Nice article by the Athersys CEO talking about regenerative medicine in Japan. He mentions that Athersys is actively engaged working to move things forward in Japan, most likely via a stroke trial. Japan's Leadership in Regenerative Medicine |
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Post by jckrdu on Aug 12, 2014 12:13:29 GMT
ATHX has dipped to 1.50 today, can it go lower?? Waiting and watching. Not sure. If they announce a delay to completing stroke enrollment and push out the results from end to 2014 to 2015, that'll certainly put downward pressure on the stock. Conference call schedule for early August. Should get an update then. Well, they did announce a delay to the stroke enrollment (previous guidance was enrollment would be complete by end of summer) and hence stroke results won't be out until 1st Qtr 2015 IMO. I expect ATHX to drop on this news. The below is from yesterday's PR. Disclosure: I have no position in ATHX at the moment. _______________________ "Advanced enrollment of Phase 2 clinical trial of MultiStemcell therapy for treatment of ischemic stroke, expecting to complete enrollment in the next several months with initial top-line results following analysis of patient data collected through 90 days after treatment; |
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Post by selluwud on Aug 12, 2014 12:54:01 GMT
Not sure. If they announce a delay to completing stroke enrollment and push out the results from end to 2014 to 2015, that'll certainly put downward pressure on the stock. Conference call schedule for early August. Should get an update then. Well, they did announce a delay to the stroke enrollment (previous guidance was enrollment would be complete by end of summer) and hence stroke results won't be out until 1st Qtr 2015 IMO. I expect ATHX to drop on this news. The below is from yesterday's PR. Disclosure: I have no position in ATHX at the moment. _______________________ "Advanced enrollment of Phase 2 clinical trial of MultiStemcell therapy for treatment of ischemic stroke, expecting to complete enrollment in the next several months with initial top-line results following analysis of patient data collected through 90 days after treatment; Good catch and thanks Jim. I will probably depart with what shares I have this morning and buy back later on the retrace. I came very close to selling before the close yesterday. |
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Post by selluwud on Aug 12, 2014 14:58:48 GMT
Well, they did announce a delay to the stroke enrollment (previous guidance was enrollment would be complete by end of summer) and hence stroke results won't be out until 1st Qtr 2015 IMO. I expect ATHX to drop on this news. The below is from yesterday's PR. Disclosure: I have no position in ATHX at the moment. _______________________ "Advanced enrollment of Phase 2 clinical trial of MultiStemcell therapy for treatment of ischemic stroke, expecting to complete enrollment in the next several months with initial top-line results following analysis of patient data collected through 90 days after treatment; Good catch and thanks Jim. I will probably depart with what shares I have this morning and buy back later on the retrace. I came very close to selling before the close yesterday. I got lucky and unloaded at 1.62 (my average) with a small profit. Will re-enter when I see a soft spot. |
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Post by JHam on Aug 18, 2014 23:12:13 GMT
Good catch and thanks Jim. I will probably depart with what shares I have this morning and buy back later on the retrace. I came very close to selling before the close yesterday. I got lucky and unloaded at 1.62 (my average) with a small profit. Will re-enter when I see a soft spot. Nice job selluwud! |
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Post by selluwud on Sept 25, 2014 12:28:30 GMT
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Post by jckrdu on Oct 16, 2014 14:17:29 GMT
Jumped back in here with a good sized position built over the past few days at an average pps of about $1.22.
IMO there are 2 near term catalysts pending 1) stroke enrollment completed, and 2) start of grant funded heart attack Phase 2 trial.
I expect some pps appreciation after stroke enrollment completion in anticipation of results in 1st/2nd Qtr 2015. Will probably take some off the table before results are announced, but IMO ATHX is undervalued at a $100 million market cap with stroke results coming soon.
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Post by jckrdu on Oct 23, 2014 6:34:09 GMT
Jumped back in here with a good sized position built over the past few days at an average pps of about $1.22. IMO there are 2 near term catalysts pending 1) stroke enrollment completed, and 2) start of grant funded heart attack Phase 2 trial. I expect some pps appreciation after stroke enrollment completion in anticipation of results in 1st/2nd Qtr 2015. Will probably take some off the table before results are announced, but IMO ATHX is undervalued at a $100 million market cap with stroke results coming soon. The Athersys CEO recently presented at the Stem Cell Meeting On Mesa in early October. (Link below. You may need to click on the Playlist in the top left to select the Athersys presentation). It's a very good presentation and hits all the relevant topics. Some hightlights... Minute 3 - Lot of focus on Japan given their soon to be announced (before EOY) updated accelerated clinical trial pathway that Athersys is going to pursue. He made a statement that Athersys just secured PMDA approval to use MultiStem in clinical trials in Japan. Minute 13 - Gil said stroke "top line data will be out early next year". First time I heard him mention top line data will be released. Before watching the presentation, my expectations were to see the full stroke results around the end of 1st Qtr or more likely 2nd Qtr 2015. His comments have me thinking we'll see TLD very soon after the 90 day period after treating the last patient. So, last patient treated let's say 10/30 + 90 days = 1/30, so TLD maybe February 2015. stemcellmeetingonthemesa.com/webcast/ |
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Post by jckrdu on Oct 24, 2014 19:34:06 GMT
Looks like many news events coming in the last 9 weeks of the year; stroke enrollment completed, AMI trial initiation, Japan's new clinical trial framework enacted (November 2014) and follow-on news from Athersys (I suspect) on how they intend to move forward in Japan under the new framework.
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Post by jckrdu on Oct 28, 2014 18:18:00 GMT
Looks like many news events coming in the last 9 weeks of the year; stroke enrollment completed, AMI trial initiation, Japan's new clinical trial framework enacted (November 2014) and follow-on news from Athersys (I suspect) on how they intend to move forward in Japan under the new framework. ATHX continues a slow move/recovery a little higher. Some more information on their initiatives in Japan below... Some CEOs are taking their cell therapies to Japan to commercialize there first, given the new legislation that's going to be enacted in Japan sometime in November 2014. This news should start hitting the wires any day/week. The legislation was first discussed a year ago (Nov 2013). Everything I'm reading says the new legislation will be enacted Nov 2014. Under Japan's new cell therapy legislation, my understanding is that companies that qualify will be able to commercialize after running a single trial that shows efficacy. The below SA article from last week goes further and speculates that data generated outside of Japan will be able to be used to qualify to sell products in Japan. I'm not so sure about that, but the point is that Japan is becoming a very attractive place to get to market in the least amount of time for cell therapies. Japan Gives A Hug To The Cell Therapy Industry: R. Lee Buckler | Seeking Alpha seekingalpha.com/article/2593755-japan-gives-a-hug-to-the-cell-therapy-industry-r-lee-buckler |
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