Right, almost. Dex is standard of care now, and any EUA would advise adding Remestemcel-L to that, not providing Remestemcel-L on its own. The EUA could be on the basis of either the results of the entire under 65 subgroup, where 48 percent mortality reduction was seen, or the exploratory analysis with Dex where 77 percent mortality reduction was seen. Here's the interesting thing: the mortality reduction for the overall under 65 group is entirely attributable to the reduction in mortality for those receiving Dex. Dex alone didn't lead to mortality reduction, and Remestemcel-L alone didn't lead to any reduction. It was only in the combination that we saw a decrease, and the difference is huge. Hopefully further trials will help solve the mystery as to why neither treatment alone showed a benefit. I suspect it is related to the fact that intubation was delayed longer in our trial than in the Mt. Sinai study or earlier studies with Dexamethasone. In our trial, those responding to Dexamethasone alone might have never ended up on a ventilator and so wouldn't be included. And when they did end up on ventilator, the Dexamethasone may have staved off inflammation enough that Remestemcel-L had a chance of helping, while others who didn't receive Dexamethasone were too fargone. Just my layperson's opinion.
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