No because the PRV is only awarded upon approval of bisantrene in paediatric AML. For this to occur we would need to conduct trials in this population which obviously carries significant risk.
In any case, this isn't a new RPDD and potential PRV, this is just confirmation from the FDA that the previous RPDD and PRV obtained for RC110 can be extended to cover RC220.
Not really anything new in the ann as far as RPDD and PRV is concerned other than confirmation that RC220 is essentially the same as RC110 in the eyes of the FDA.
What is new is the interest from paediatric oncology groups in the US wanting to use bisantrene in trials. That is extremely positive news and a firm validation of the science.
No because the PRV is only awarded upon approval of bisantrene...
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