Ann: EAP for Remestemcel-L in Children with MIS-C due to COVID-19, page-91

I don't think the FDA needed much more than (a) the previous EAP for ARDS; (b) the AGVHD trials results; and (c), and the COPD results (with the latter maybe being also be why Dr Grossman focused on the cardiovascular aspect of MIS-C) to give the thumbs up for the extension of the initial EAP.

It doesn't have to have anything to do with interim results from the NIH ARDS trial at all.

Again, it's a syndrome that is not getting, from what I have seen, any particular focus for treatment by any other manufacturers, and there doesn't seem to have been much published, clinically or academically, on treatments and outcomes for MIS-C, either.

I see this as SI and MSB being wisely opportunistic, and stepping in, AGAIN, to try to manage a syndrome that's beyond the reach of any other drugs or treatments. And why not? We all know that Rem-L appears to works best when the inflammation has spread beyond control of the standard of care treatments and is attacking multiple systems and organs.

The real question I have is whether MSB went after this extension on their own, or were urged to do so by the FDA or other individuals in the medical establishment, those running the existing trial, etc. Would love to be a fly on the wall in the MSB War Room - must be an exciting time for them!