Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-189

Like most I have been a little disappointed it took this long for the NIH to recruit 90 ARDS patients and agree with some of the above, that I would rather see results on more than 90 patients before the trial is stopped for efficacy. But surely by early September they will have at least 150 patients given the original time-lines advised? If they stop due to efficacy, I am presuming the results will stand for the entire sample size at that time, once all stats are compiled.

MSB is really playing this by the book, with super tight controls on their phase 3 trials. That the company has literally been uninvolved in the trials (bar the chief medical officer in some respects) puts the results, however they are, beyond reproach. If the DSMB does stop the trial there for efficacy and ethical reasons and recommend REM-L for emergency use, even with a smaller sample size of say 150 by that time, should be statistically significant enough, given the very tight testing regime.

I applaud MSB for its very tight standards of trials, but fear other treatments will gain traction in the market the longer this rolls on. I am in MSB for more than just ARDS, but success there would be a bonus and with the amount of questionable treatments out there, it would be nice if REM-L was an available option to the thousands dying around the world sooner than later.