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Post by imz72 on Aug 12, 2020 8:54:22 GMT
Hardy's Q2 2020 briefing in English: www.net-presentations.com/4593/20200807e/_______________________________________________ New Dawson James (Jason Kolbert) report (August 11, 2020) :
"Adjusting for the recent raise (increase in shares), our price target falls from $12.00 to $7.00 per share". dawsonjames.com/wp-content/uploads/2020/08/ATHX.DJ_.8.11.2020..pdf________________________________________________________________ Healios announces full enrolment of COVID-19 Induced ARDS Patient Cohort in ONE-BRIDGE study of HLCM051 for the Treatment of ARDS in Japan
August 12, 2020 HEALIOS K.K. (“Healios”) today announces that it has fully enrolled the planned five patients in the COVID-19 induced Acute Respiratory Distress Syndrome (ARDS) cohort of its ONE-BRIDGE clinical trial of HLCM051 to treat ARDS in Japan. The group of five pneumonia-induced ARDS patients with COVID-19 was newly added to the ONE-BRIDGE study to test the safety of the treatment in patients with COVID-19 induced ARDS and the first patient was enrolled on July 29, 2020. The enrolment of these five patients was conducted separately from the original cohort of 30 ARDS patients. We continue to enroll patients in the 30 patient pneumonia induced ARDS cohort and expect to complete enrolment in the fourth quarter of this year. Regarding the overview of the trial, please refer to our company’s press release on April 13, 2020. Healios will decide further steps after conducting the safety assessment and discussing with medical specialists and relevant authorities. “Amid the rapid increase in the number of patients in Japan with the novel coronavirus, and with the strong support of the physicians and other healthcare professionals involved, we were able to rapidly complete enrolment of the COVID-19 cohort of our trial. We are working to complete the ONE-BRIDGE study in consultation with relevant authorities so that this important medicine for ARDS can be delivered to patients as soon as possible,” commented Hardy TS Kagimoto, MD, Chairman and CEO of Healios. ssl4.eir-parts.net/doc/4593/tdnet/1874762/00.pdf
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Post by md2008 on Aug 12, 2020 11:44:32 GMT
So 28 day click starts?
Anyone know if PMDA can analyze that arm of trial before ards non-covid is complete?
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Post by imz72 on Aug 12, 2020 12:54:18 GMT
So 28 day click starts? Anyone know if PMDA can analyze that arm of trial before ards non-covid is complete? My understanding is that the answer is negative. According to ClinicalTrials site/ One-Bridge/ Outcome Measures the only 28 days data point is for ARDS caused by pneumonia. All the other 34 data points are for the COVID-19 cohort and are of 180 days: clinicaltrials.gov/ct2/show/NCT03807804
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Post by md2008 on Aug 12, 2020 13:27:27 GMT
So 28 day click starts? Anyone know if PMDA can analyze that arm of trial before ards non-covid is complete? My understanding is that the answer is negative. According to ClinicalTrials site/ One-Bridge/ Outcome Measures the only 28 days data point is for ARDS caused by pneumonia. All the other 34 data points are for the COVID-19 cohort and are of 180 days: clinicaltrials.gov/ct2/show/NCT03807804If they wait 180 days for an endpoint on COVID 19, that is a huge study design flaw.
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Post by selluwud on Aug 13, 2020 17:04:58 GMT
I can't see where there is thread for MESO which is similar to ATHX, but I'm curious about the the market halt they've been in since premarket this morning. Meeting with FDA about product consistency? Anybody know anything here?
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Post by imz72 on Aug 13, 2020 20:04:21 GMT
I can't see where there is thread for MESO which is similar to ATHX, but I'm curious about the the market halt they've been in since premarket this morning. Meeting with FDA about product consistency? Anybody know anything here? Request for trading halt for Mesoblast Limited (ASX: MSB) Pursuant to ASX Listing Rule 17.1, Mesoblast Limited ACN 109 431 870 (ASX: MSB; NASDAQ:MESO) (the Company) requests a trading halt in its securities effective immediately pending an announcement by the Company in relation to the upcoming meeting of the Oncologic Drugs Advisory Committee of the United States Food and Drug Administration. For the purposes of Listing Rule 17.1, the Company provides the following information: (a) the trading halt is requested pending an announcement in relation to the matters above; (b) the Company requests that the trading halt continues until it makes an announcement regarding the matters above which is expected to be on Friday, 14 August 2020; ______________________________________________________________ The securities of Mesoblast Limited (‘MSB’) will be placed in trading halt at the request of MSB, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 17 August 2020 or when the announcement is released to the market. investorsmedia.mesoblast.com/static-files/6c142520-541f-445e-80d0-d7570337e255
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Post by selluwud on Aug 13, 2020 21:17:06 GMT
I can't see where there is thread for MESO which is similar to ATHX, but I'm curious about the the market halt they've been in since premarket this morning. Meeting with FDA about product consistency? Anybody know anything here? Request for trading halt for Mesoblast Limited (ASX: MSB) Pursuant to ASX Listing Rule 17.1, Mesoblast Limited ACN 109 431 870 (ASX: MSB; NASDAQ:MESO) (the Company) requests a trading halt in its securities effective immediately pending an announcement by the Company in relation to the upcoming meeting of the Oncologic Drugs Advisory Committee of the United States Food and Drug Administration. For the purposes of Listing Rule 17.1, the Company provides the following information: (a) the trading halt is requested pending an announcement in relation to the matters above; (b) the Company requests that the trading halt continues until it makes an announcement regarding the matters above which is expected to be on Friday, 14 August 2020; ______________________________________________________________ The securities of Mesoblast Limited (‘MSB’) will be placed in trading halt at the request of MSB, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 17 August 2020 or when the announcement is released to the market. investorsmedia.mesoblast.com/static-files/6c142520-541f-445e-80d0-d7570337e255I don't own any but see a small binary moment where it may jump one way or the other depending the meeting out come. Thanks for the info.
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Post by selluwud on Aug 14, 2020 11:43:49 GMT
Request for trading halt for Mesoblast Limited (ASX: MSB) Pursuant to ASX Listing Rule 17.1, Mesoblast Limited ACN 109 431 870 (ASX: MSB; NASDAQ:MESO) (the Company) requests a trading halt in its securities effective immediately pending an announcement by the Company in relation to the upcoming meeting of the Oncologic Drugs Advisory Committee of the United States Food and Drug Administration. For the purposes of Listing Rule 17.1, the Company provides the following information: (a) the trading halt is requested pending an announcement in relation to the matters above; (b) the Company requests that the trading halt continues until it makes an announcement regarding the matters above which is expected to be on Friday, 14 August 2020; ______________________________________________________________ The securities of Mesoblast Limited (‘MSB’) will be placed in trading halt at the request of MSB, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 17 August 2020 or when the announcement is released to the market. investorsmedia.mesoblast.com/static-files/6c142520-541f-445e-80d0-d7570337e255I don't own any but see a small binary moment where it may jump one way or the other depending the meeting out come. Thanks for the info. MESO is blasting off this AM, the advisory committee gave their approval of RYONCIL for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Still pending FDA approval. Maybe ATHX will rise with the tide in the stem cell sector??
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Post by jckrdu on Aug 15, 2020 19:46:22 GMT
I don't own any but see a small binary moment where it may jump one way or the other depending the meeting out come. Thanks for the info. MESO is blasting off this AM, the advisory committee gave their approval of RYONCIL for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Still pending FDA approval. Maybe ATHX will rise with the tide in the stem cell sector?? I own both Athx and Meso. IMO, MESO is going to keep trending higher leading up to the 9/30 Pdufa date for GVHD. MESO was more aggressive with Covid compassionate use treatments and results, and is guiding for an “early September” DSMB review of 90 patients in their Covid trial. IMO, makes sense to own some Meso in the event the trial is stopped early for efficacy. Based on all the worldwide anecdotal successes we’ve seen with MSC cells ability to dramatically reduce inflammation and promote healing, meso’s 90 patient Dsmb review is large enough where data could show impressive results, and garner national news. Still like ATHX longer term for Ards results from Japan later this year and stroke.
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Post by jckrdu on Aug 16, 2020 17:17:47 GMT
MESO is blasting off this AM, the advisory committee gave their approval of RYONCIL for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Still pending FDA approval. Maybe ATHX will rise with the tide in the stem cell sector?? I own both Athx and Meso. IMO, MESO is going to keep trending higher leading up to the 9/30 Pdufa date for GVHD. MESO was more aggressive with Covid compassionate use treatments and results, and is guiding for an “early September” DSMB review of 90 patients in their Covid trial. IMO, makes sense to own some Meso in the event the trial is stopped early for efficacy. Based on all the worldwide anecdotal successes we’ve seen with MSC cells ability to dramatically reduce inflammation and promote healing, meso’s 90 patient Dsmb review is large enough where data could show impressive results, and garner national news. Still like ATHX longer term for Ards results from Japan later this year and stroke. Note on MESO risks, for anyone considering taking a position: Phase 3 data read outs for heart failure and lower back pain guided for "mid 2020", so those results could come at any time. Positive results will add to buying pressure. Negative results will give some gains back. IMO, GvHD 9/30 PDUFA date (expected FDA approval) and Covid/Ards results will ultimately carry the day.
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Post by selluwud on Aug 24, 2020 17:38:27 GMT
I'm just wondering if the FDA approval of Covid Plasma treatments is killing the Covid related stocks today. Taking a beating I am. Planning on a comeback though!
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Post by imz72 on Aug 31, 2020 18:35:20 GMT
New on ClinicalTrials.gov: clinicaltrials.gov/ct2/show/NCT04533464________________________ MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Recruitment Status: Not yet recruitingFirst Posted: August 31, 2020 Brief Summary: Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation. Estimated Enrollment: 156 participantsEstimated Study Start Date: August 2020 Estimated Primary Completion Date: September 2022Estimated Study Completion Date: August 2023Primary Outcome Measures:
1. A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines) [ Time Frame: Day 30 ] Secondary Outcome Measures:
1. Mortality [ Time Frame: Day 30, Day 90, Day 365 ] mortality including median time to death within the acute hospitalization period 2. Incidence of Acute Kidney Injury adjusted for the competing risk of death [ Time Frame: Day 30 ] 3. Incidence of sepsis, Acute Respiratory Distress Syndrome, Multiple Organ Failure, and Venous Thromboembolism [ Time Frame: Day 30 ] 4. Hospital days [ Time Frame: Day 30 ] Free days will be defined as the number of days an individual was alive and not in the hospital. 5. ICU days [ Time Frame: Day 30 ] Free days will be defined as the number of days an individual was alive and not in the ICU. 6. ventilator-free days [ Time Frame: Day 30 ] Free days will be defined as the number of days an individual was alive and not on the ventilator.
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Post by imz72 on Sept 13, 2020 15:27:56 GMT
Recent hires help Athersys prepare for potential commercialization
LYDIA COUTRÉ, September 13, 2020 In anticipation of potential approval of its MultiStem stem cell therapy, Cleveland biotechnology company Athersys Inc. is taking steps to be ready for possible commercialization. Twenty-five years after it was founded in Cleveland, the company is actively preparing for what it expects to be successful results of multiple studies in the United States, as well as abroad in collaboration with its Japanese partner Healios KK "Making that transition from being a development company or a late-stage development company into becoming a full-blown commercialization company is critically important," said Gil Van Bokkelen, chairman and CEO of Athersys. "It's a transition that few companies have been able to make, but the ones that have have become household names." As part of that effort, Athersys hired two new executives earlier this year to bolster its management team. Veteran pharmaceutical executive Ivor Macleod joined as the company's chief financial officer, and Maia Hansen, formerly a senior partner at global management consulting firm McKinsey & Co., is now the senior vice president of operations and supply chain at Athersys. Macleod's commercialization experience and Maia's supply chain experience will be integral to the company's work moving forward. Athersys' MultiStem cell therapy is a patented, proprietary stem cell product currently under evaluation in several clinical trials. It has shown promise for treating indications in the areas of neurological, inflammatory and immune, and cardiovascular diseases, as well as other critical care conditions. The opportunity to join Athersys was exciting to Hansen because of MultiStem's potential to serve a broad population with its off-the-shelf product, rather than precision medicine, which is the application of individualized, tailored treatments. Plus, she noted, Athersys is working in therapies that have long been critical clinical needs — stroke, trauma and acute respiratory distress syndrome (ARDS). Healios is studying MultiStem in the TREASURE study for treatment of ischemic stroke and in the ONE-BRIDGE study for treatment of ARDS. They expect to complete enrollment in both studies by the end of this year, with results available in the first few months of next year. Van Bokkelen said Athersys and Healios have already started work preparing the regulatory package that would ultimately be submitted to authorities in Japan for potential approval.
In the United States, Athersys plans to complete enrollment next year in its MASTERS-2 study, a Phase 3 program for ischemic stroke, as well as in its MACOVIA study , which was initiated in April to evaluate using MultiStem to treat COVID-19-induced ARDS. Athersys also is getting ready to launch a Phase 2 study in trauma treatment. Next on the horizon is a trial to study treating hemorrhagic stroke.
"The reality of it is if we're successful in any of those, then it's going to create a huge opportunity," Van Bokkelen said. Macleod gets many questions about why he would join a small biotech company after his experience in large pharma, including holding leadership positions at Merck & Co., F. Hoffmann-La Roche and Boehringer Mannheim Therapeutics, among others. Before Athersys, he was CFO of Eisai, the US subsidiary of Japanese company Eisai Ltd. He said the science and regenerative medicine initially attracted him to Athersys, as well as the opportunity to impact the critical care space, which has a lot of unmet medical need. He was impressed with the "very driven, very intelligent" leadership team. In the six months Hansen has been with Athersys, she has spent a lot of her time building fundamentals for the future — thinking about what a new, larger scale production site would look like to build out the company's supply chain capabilities. Because the company is in Phase 2 and Phase 3 trials, it needs to produce more clinical doses both for existing work and to prepare to produce at a much larger scale, she said. "And that, given my background, is very exciting," Hansen said. "Going from a clinical stage company to a commercial stage company is also about transitioning your internal processes, building your manufacturing and supply chain capacity, and that's something that I've done for 25 years in other contexts. And it's kind of exciting to roll up my sleeves in a company that has a lot of opportunity for developing those processes kind of from the ground up." While Hansen and Macleod will help the company work toward commercialization in North America, Athersys is looking for a partner to help advance toward that in Europe. Finding a partner that can help Athersys drive forward development and commercialization in Europe is a big priority for the company that Van Bokkelen said could be transformational in addition to the clinical progress. With so many different countries — each with their own rules around promotion, reimbursement structures, etc. — finding a partner to navigate them makes the most sense.
He said the companies Athersys is considering are multinational with capabilities in other parts of the world as well, hopefully giving Athersys the latitude to work with them to grow the partnership over time.
Because Athersys works in the critical care space, it will serve a more focused market rather than, for instance, a typical primary care launch that requires "endless promotion" with all major doctors across the country, Macleod said. The targeted approach and concentrated marketplace puts Athersys in a unique position for commercialization, he said. The company can decide which capabilities to have internally and which to subcontract. "Whereas (in) traditional pharma, you tend to go through the big wholesalers, and so it's just a question of which ones you contract with, how much you pay them, all the different middlemen," he said. "We actually have a possibility of not necessarily having any middlemen. You know, these are some of the things we're looking at, so it really is quite a unique opportunity." Athersys intentionally avoided markets that are pretty well served with existing standards of care and opted to focus on areas with limited treatment options, Van Bokkelen said. "And that's because we believe our technology can effectively address those indications based on the evidence, clinical and other evidence that we've generated over many years," he said. "But also because we think it's a smart thing to do from a development standpoint. If you go after the opportunities that many other companies have been forced to shy away from because they haven't figured out an effective way to deal with those challenges, or solve those problems, then that means you've got a huge potential advantage if you are the company that actually succeeds in fundamentally improving clinical care for those patients that really need help." www.crainscleveland.com/health-care/recent-hires-help-athersys-prepare-potential-commercialization
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Post by selluwud on Sept 16, 2020 11:40:00 GMT
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Post by imz72 on Sept 23, 2020 10:09:21 GMT
FDA Grants RMAT Designation to MultiStem Cell Therapy for the Treatment of Acute Respiratory Distress Syndrome
September 23, 2020 ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation
CLEVELAND--(BUSINESS WIRE)-- Athersys, Inc., a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the acute respiratory distress syndrome (ARDS) program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval. The RMAT designation for ARDS is granted in addition to the previously obtained Fast Track designation awarded in May 2019. MultiStem is the only cell therapy program for ARDS that has both Fast Track and RMAT designation from the FDA. Also, the Company’s partner in Japan, HEALIOS K.K. (Healios), is anticipating the completion of enrollment in its orphan designated ARDS clinical trial (ONE-BRIDGE) by the end of this year. “We are very pleased to have received our second MultiStem program RMAT designation,” commented Dr. Manal Morsy, Senior Vice President and Head of Global Regulatory Affairs. “We have enjoyed close and highly efficient interactions with the FDA on our RMAT-designated ischemic stroke program and are looking forward to similar benefits and advantages of this Expedited Program for Regenerative Medicine Therapies for Serious Conditions RMAT designation, this time for ARDS.” The Company has conducted extensive research exploring MultiStem cell therapy for the treatment of pulmonary distress and recently completed an exploratory Phase 1/2 clinical trial for the treatment of ARDS (the MUST-ARDS study). Participants in the randomized, double-blind, placebo-controlled MUST-ARDS study were evaluated through 28 days for the primary clinical assessment and further assessed through a one-year follow-up period. Patients that received MultiStem experienced lower mortality, fewer days on a ventilator, fewer days in the intensive care unit, and reported a higher quality of life after one-year post-ARDS than patients that received the placebo. Following the encouraging results of the MUST-ARDS study, the Company began planning for the next stage of clinical evaluation. In response to the COVID-19 pandemic, the Company expedited the initiation of a pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy for the treatment of COVID-19 induced ARDS (the MACOVIA study), which is now enrolling patients. The primary efficacy endpoint for the randomized, double-blind, placebo-controlled study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability, and QoL among survivors through one-year of follow-up. MultiStem may have the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS because it is not virus- or pathogen-specific. For more detailed information on the Company’s ARDS program, please visit the ARDS page on the Athersys website. www.athersys.com/investors/press-releases/press-release-details/2020/FDA-Grants-RMAT-Designation-to-MultiStem-Cell-Therapy-for-the-Treatment-of-Acute-Respiratory-Distress-Syndrome/default.aspx
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Post by selluwud on Sept 23, 2020 12:15:21 GMT
FDA Grants RMAT Designation to MultiStem Cell Therapy for the Treatment of Acute Respiratory Distress Syndrome
September 23, 2020 ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation
CLEVELAND--(BUSINESS WIRE)-- Athersys, Inc., a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the acute respiratory distress syndrome (ARDS) program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval. The RMAT designation for ARDS is granted in addition to the previously obtained Fast Track designation awarded in May 2019. MultiStem is the only cell therapy program for ARDS that has both Fast Track and RMAT designation from the FDA. Also, the Company’s partner in Japan, HEALIOS K.K. (Healios), is anticipating the completion of enrollment in its orphan designated ARDS clinical trial (ONE-BRIDGE) by the end of this year. “We are very pleased to have received our second MultiStem program RMAT designation,” commented Dr. Manal Morsy, Senior Vice President and Head of Global Regulatory Affairs. “We have enjoyed close and highly efficient interactions with the FDA on our RMAT-designated ischemic stroke program and are looking forward to similar benefits and advantages of this Expedited Program for Regenerative Medicine Therapies for Serious Conditions RMAT designation, this time for ARDS.” The Company has conducted extensive research exploring MultiStem cell therapy for the treatment of pulmonary distress and recently completed an exploratory Phase 1/2 clinical trial for the treatment of ARDS (the MUST-ARDS study). Participants in the randomized, double-blind, placebo-controlled MUST-ARDS study were evaluated through 28 days for the primary clinical assessment and further assessed through a one-year follow-up period. Patients that received MultiStem experienced lower mortality, fewer days on a ventilator, fewer days in the intensive care unit, and reported a higher quality of life after one-year post-ARDS than patients that received the placebo. Following the encouraging results of the MUST-ARDS study, the Company began planning for the next stage of clinical evaluation. In response to the COVID-19 pandemic, the Company expedited the initiation of a pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy for the treatment of COVID-19 induced ARDS (the MACOVIA study), which is now enrolling patients. The primary efficacy endpoint for the randomized, double-blind, placebo-controlled study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability, and QoL among survivors through one-year of follow-up. MultiStem may have the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS because it is not virus- or pathogen-specific. For more detailed information on the Company’s ARDS program, please visit the ARDS page on the Athersys website. www.athersys.com/investors/press-releases/press-release-details/2020/FDA-Grants-RMAT-Designation-to-MultiStem-Cell-Therapy-for-the-Treatment-of-Acute-Respiratory-Distress-Syndrome/default.aspx Glad to hear some kind of news here, it's been nothing but crickets. Where's BARDA
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Post by tmfbmf on Oct 15, 2020 14:52:27 GMT
I asked Karen about the departure of Kenneth Traub from the BOD. Her response:
"Ken made a personal decision to resign from the board, but his departure was amicable. We appreciate the time he had with us, and we expect to add an additional board member after completing the appropriate search process."
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Post by selluwud on Oct 20, 2020 14:03:34 GMT
With no news or data release, this issue is tanking. Antibody treatments and vaccines may render the Macovia trials moot. Still a shot at Stroke and ARDS in general though.
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Post by avtech on Oct 20, 2020 15:27:14 GMT
I've been invested in ATHX for years. Stroke has always been my target. Anything else would be nice but I am fine waiting for stroke approval.
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Post by tmfbmf on Oct 20, 2020 20:21:46 GMT
With no news or data release, this issue is tanking. Antibody treatments and vaccines may render the Macovia trials moot. Still a shot at Stroke and ARDS in general though. MACOVIA won't be moot. Gil designed the trial with the ability to change to general ARDS. He knew government $$$ might not come in and had the foresight to design a flexible trial with the help of the FDA.
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