Yes we could run trials and get approvals in other countries and the EU block. They all have their own regulatory bodies. But we won't because it would take too much time and money.
If the FDA won't agree to a acceptable path forwards the rational thing to do is abandon pediatric GVHD, it's a very small market.
Lets see what the Covid ARDS, CHF and CLBP readouts are...
Yes we could run trials and get approvals in other countries and...
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