Ann: S&P DJI Announces March 2022 Quarterly Rebalance, page-61

This is what I think. The company go t a little greedy in it's original BLA application and was talking about under 18s rather than under 12's I think. Someone can correct me here if that was not the case. For the portion of kids over 12, there are approved treatments, but for under 12 there are not.

I do believe this time they are sticking with the under 12 segment - which has big unmet needs, and provided they are happy with manufacturing, and with the additional proof of efficacy provided by the third party in their magic score analysis, I think it will be approved. The extra trial will happen in adults, but will also allow label extension into adult GvHD once approved, and then into ARDS, Crohns, Sepsis, etc.

We should find out in 3 or so months assuming the company tell us the FDA has accepted their resubmission. They only do that if they believe the CRL items have been addressed. If they were absolutely hard over another trial prior to BLA, then they would not accept the resubmission