It's the "false hope" part that I think needs to be ironed out....

It's the "false hope" part that I think needs to be ironed out. It seems to me (after quickly going through the CC parts I missed), after communications vie the Dispute Resolution Process, it was the manufacturing and potency items that needed to be sorted out, and then once sorted out they would consider it for the approval of children and mesoblast would still need to conduct a confirmatory trial in adults thereafter (or something to that effect).

Anyway the FDA were happy with potency and manufacturing, so... why not just approve for the children and have a confirmatory trial in children/adults? to me that is key and hence why I think we have to understand where the "false hope" comes from: Was it the FDA in fact changing goal posts? Mesoblast communications? a bit of both? ultimately we don't have the full dialogue between them so we can only speculate for now.