Not on children no, part of the issue was that prochymal/ryoncil became available under an EAP part of the way through the initial Osiris P2. All the children in P2 were directed into the EAP, as were any others whose doctors pointed their parents to it. That was the beginning of the 241 patient EAP study.
Very hard to run a double blinded study in children when it is very strongly suspected the product being supplied on the active arm actually works, the the doctors have known that for some time, when they know the death rate on the placebo control arm will be very high. Something to do with ethics and children.
I re-posted a video that discusses that P2 time frame a few weeks ago.
Mesoblast Company Update - Webcast and Forward Thoughts, page-195
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