From @LeftYahoo re the SI must go - a Comparison to Athersys's (and their CEO's) performance:10 hours agoGroupInvestor has said that based on share price results, Mesoblast's CEO should suffer the same fate, ie “early retirement”, as $ATHX's. For each investor to decide. Meanwhile, here's Left-e's handy list of clinical trial and FDA announcements made by both companies over the past year. For your reading convenience, those announcements that allowed investors to make direct inferences as to patient outcomes (positive or negative) or progress towards FDA approval get a ** after the date. Those that deal only with an IND/ initiation of a trial or hitting enrollment percentages do not.
01 April 2020** FDA Accepts BLA for RYONCIL and Agrees to Priority Review
06 April 2020 FDA Clears IND for Remestemcel Use in COVID-19 ARDS Patients
09 April 2020 US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial
17 April 2020** Inflammatory Lung Disease Outcomes For Presentation at ISCT
24 April 2020** 83% Survival in COVID-19 ARDS Patients with Remestemcel-L
30 April 2020 Phase 2/3 Trial in COVID-19 ARDS Begins Enrollment
06 May 2020 First Patients Dosed in Phase 2/3 Trial for COVID-19 ARDS
25 May 2020** 3 Articles on RYONCIL GvHD Trial Results Published in BBMT
01 June 2020** Remestemcel-L Improves Outcomes in Inflammatory Lung Disease
06 July 2020 EAP for Remestemcel-L in Children with MIS-C due to COVID-19
21 July 2020** FDA Advisory Committee Sets Review Date for Remestemcel-L
30 July 2020** COVID-19/GVHD Update, Quarterly Report and Appendix 4C
14 August 2020** ODAC Votes in Favor of Remestemcel-L for GvHD
02 September 2020 Ethics Approval to Treat COVID-19 Patients in Australia
04 September 2020** DSMB Recommends Continuation of Phase 3 COVID-19 Trial
02 October 2020** Update on BLA for Graft Versus Host Disease
13 October 2020 Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment
22 October 2020 Remestemcel Controlled Study in Crohns & Ulcerative Colitis
11 November 2020** DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial
02 December 2020** Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS
07 December 2020** Remestemcel-L Reduces Biomarkers for Mortality in SR-aGVHD
15 December 2020** Mesoblast Phase 3 Chronic Heart Failure Results
18 December 2020** Mesoblast Update on COVID-19 ARDS Trial
11 January 2021** Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF
11 February 2021** Mesoblast Phase 3 Chronic Low Back Pain Results
17 February 2021** Remestemcel-L for COVID-19 MIS-C published in Pediatrics
Here's the list for Athersys
13 April 2020 FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem® Cell Therapy in Patients With COVID-19 Induced Acute Respiratory Distress Syndrome
15 April 2020 FDA Authorizes Initiation of a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma Patients
1 May 2020 Athersys and University Hospitals Cleveland Medical Center Announce Activation of the First Clinical Site for the MACOVIA Study, a Pivotal Phase 2/3 Study Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS
5 May 2020 Athersys Announces Commencement of Patient Enrollment in the MACOVIA Study, a Pivotal Phase 2/3 Trial Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS
18 May 2020** Athersys Announces Upcoming Presentations at the International Society of Cell and Gene Therapy Virtual Conference
23 September 2020** FDA Grants RMAT Designation to MultiStem Cell Therapy for the Treatment of Acute Respiratory Distress Syndrome
21 December 2020 UTHealth in Houston and Athersys Announce Commencement of Patient Enrollment in a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma
31 March 2021 Athersys Reports That Healios Has Completed Enrollment in the ONE-BRIDGE Study of MultiStem® for Acute Respiratory Distress Syndrome in Japan
Totals: Mesoblast 26 Announcements with 18 getting a **
Athersys 8 Announcment with 2 getting a **
GLTA
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