Fails to mention that to be awarded the PRV, the first FDA approval for RC220 has to be in Paediatric AML. If RC220 is approved for any other indication first, PRV is off the table.
I hate it when companies fail to mention that in RPDD announcements. This one even had a FAQ section at the end!
So is Paediatric AML the priority indication for Race now? Will other programs be paused/stalled/slowed to ensure that Paediatric AML gets across the line first? These are some actual questions to address in a RPDD announcement.
Ann: FDA RPD Designation Granted for RC220 Bisantrene, page-13
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