Analysis of the EAP, page-196

@imback, I've been meaning to get back to you on your interesting post about Athersys conducting its Phase 2 "lead-in"

For starters, I have to say you have a lot more patience than I do to sit through an Athersys CC. Bravo.

For comparison, Mesoblast announced its EAP on April 6. It announced the start of enrollment in the phase 2/3 trial just 24 days later on April 30. I suspect there was never any doubt about dosing: 2x10^6 cells/kg, repeat once at 3-5 days, if needed.

As far as we can tell from interviews with both SI and Dr. Grossman, they are enrolling 300 patients now in the phase 3 part, no lead-in. So, apparently the FDA liked what they saw at that dose in term of safety and efficacy. No questions. It appears the EAP functioned as a phase 2 and Mesoblast is now enrolling in the phase 3 part of the trial.

Compare Athersys, still trying to find dose. The most telling thing in your transcription of the CC: NO actual mention of the two doses they are going to try. In their phase 1 ARDS study, the low dose arm received 300M cells and the high dose arm received 900M cells. They then conducted the phase 2 portion of the study using 900M cells (which tells us something). We know they are using 1.2 Billion cells in the phase 3 stroke study. Has this company found a maximum dose yet? So, NO mention of dose in the CC and no mention of dose in the registered phase 2/3 MACovia trial. This Company is still searching for the correct dose until proven otherwise. It might take them months as you point out while they wait 28 days to ensure safety. If they do sequential enrollment that could stretch into years. They are enrolling at 2 different sites, both in Cleveland. Estimated primary completion date 9/2021. The most interesting thing would be to know if they are testing 900M low dose arm and 1.2B high dose arm. Maybe they'll try doses higher than that? That's what phase 2 if for.

As an investor these issues would not instill confidence. I want to see a company moving swiftly into phase 3 with multiple centers for enrollment spread out around the country to buffer any shifts in the epidemic as seasons change. North, South, East coast, and West coast. Precisely like Mesoblast. If the epidemic is brought under control in one region, enrollment might suffer if limited to just one city. Therefore, I can't rule out the possibility this is a "show trial" from Athersys... they have to do something since they tripled their share price on C-19 hype and raised capital on it. Now, they may be slow walking to conserve cash. Wait for the stroke results, let Healios carry the ARDS load. IMO Investors really deserve more info - or should be asking tougher questions - of a company that didn't even risk doing an EAP. They say it was for "financial reasons", who's going to pay for the cells? Right... another possibility is they didn't want to risk the wrong dose with an EAP that would have had to be reported to shareholders if it didn't work at 900M cells. Can't understand why anyone is invested there.