Ann: Appendix 4C Quarterly Activity Report, page-232

The part that perplexes me is trying to compare the results above from the NEJM on dexamethasone vs the results we saw in our study. Specifically if we look at the top right quadrant for mechanical ventilation you start with a similar overall mortality at ~41% for standard of care vs 29% for dexamethasone. The results of Dexamethasone are a significant improvement, but in our study Dexamethasone showed a mortality in the mid 40s (I.e. no change vs standard of care). The study doesn’t cite the level of severity, which could be the differentiating factor or the results could be a statistical anomaly due to the population size.

Outside of that quadrant we see little to no separation between the standard of care and dexamethasone. Interesting enough Dexamethasone is the standard of care so would love to see a refresh of that top right quadrant as of today.

If you compare the mortality to our study Remestemcel had a ~26% mortality, which is relatively close to the 29% for Dexamethasone. However, we dramatically improved to a 14% mortality as a combination therapy albeit with a study population of 73. So I think it is fair to say the FDA won’t say no but the question is what next?

The keyboard warrior