Exactly @stokdog
Let's not forget although this product is still being used through the EAP, it is a life saving treatment in children no less so I cannot see the FDA dilly dallying with the approval process ?
The rolling submission allows for continual reviews of information submitted and we have extensive data from treatments both within the trials in the USA and externally in Japan with Temcell so I would hope the FDA gives our BLA the priority assessment it IMO deserves.
GLTAH
Ann: MSB Files GvHD Clinical Efficacy and Safety Data with US FDA, page-39
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