Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-165

I'm also impressed with the "quietly and professionally getting on with things".

We only have to look at other cell-based therapeutics to get an idea of how bold some of the moves have been. On March 10 the announcement is made to pursue development of a treatment for Covid-19 lung disease, despite limited previous experience with pulmonary illnesses. By April 6 we learn treatment for the most critically ill ventilator patients with ARDS has been authorized by the FDA... and just 18 days later we learn the EAP results with 83% survival in a population where 88% mortality was expected. With the filing of the trial protocols we learn the company went straight to a dose of 2x10^6 cells/kg, a move that can only be fully appreciated by comparison with other competitors. No other doses, no "higher" doses, were ever under consideration. Competitor Athersys elected not to offer an EAP, and it turns out they weren't comfortable with dosing in Covid-19, despite having RCT experience treating ARDS. They are now bogged down testing higher doses (reportedly 900M and 1.2B cells x 2 infusions). Pluristem offered an EAP, published promising results, but they too are hesitating in order to test several dosage regimens in phase 2. Mesoblast got a green light from the FDA to move straight into a large multi-center trial in partnership with the NIH. It's a question of knowing well what the therapeutic can do, knowing it's dose-response curve, and not hesitating to let it tackle the disease of the century at established doses. The moves exude confidence. Not everything, but certainly a lot, has been put on the line... failure will not be smiled upon by the market.
Meanwhile, we've just learned a competing therapeutic, Tocilizumab, did fail a large phase 3 trial. It's an anti-IL-6 monoclonal antibody already FDA-approved to treat rheumatoid arthritis and cytokine release syndrome. Not even a blip of an efficacy signal. Also important because many pediatric ICUs have been using it to treat MIS-C. So, it opens the door a little wider perhaps for that indication also under investigation for treatment with rem-L. And supports the foundational thesis that living cells might be a better therapeutic in critical C-19 cases than inanimate monoclonal antibodies. Let's see what happens with primary competitors leronlimab and lenzilumab, also inanimate monoclonal antibodies. Time and trials will tell, but as an investor I'm impressed by the direct lines connecting remestemcel-L point A to point Z with the finish line now in view. No hyping and no zig-zags, no sign of doubt whatsoever along the way.