Yea I get that.
But the initial NDA application needs to for either:
Paediatric AML
Paediatric and adult AML
If approved in adults only, initially, then PRV is off the table even if approved for Paediatric AML further down the track.
That's how it reads and how I've understood it. Would be happy to be corrected as I hold several other RPDD biotechs.
Ann: FDA RPD Designation Granted for RC220 Bisantrene, page-58
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