Another thing about yesterday's submission that appears to have been missed by many is that if these new assays are agreed to, then they will be the same assays for the covid trial to commence.
the covid trial only used 1- 2 bags, whereas the kids trial uses a stack load more from memory maybe 16 bags (weight based) so while it some have said it makes sense to expand to adults, no it doesn't! The amount of cells required to treat one patient means they need to be using bio/3D tech for that, covid doesn't. Eg the trial states 2x10^6 per kg twice a week for 4 weeks. Taking my 12 yo only weighs 50kg that means a 100m bag X 2 X 4 8 bags per patient (nct02336230) plus a potential Further dosage. So you use say 12 bags per patient. Whereas covid uses same but once, so anyone over 50kgs will get 2 bags.(nct04361393) So you get to treat 6 adult patients against 1 child. I know it's a cruel comparison but that also indicates what it should cost $400k / 6 = $67k per patient maybe
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Ann: Submits New Information to FDA IND File for SR-aGVHD, page-136
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