Happy to answer any questions about this announcement. While the news is somewhat expected given last weeks announcement around the ODD, the conversations we have been having with clinicians around the trial is new and quite exciting. The FDA expects that you have a clear paediatric program for your drug if it might be used off label in children and this program fulfils this need.
One thing that people should not forget is that cardiotoxicity caused by chemotherapy is a huge, huge problem in children. While we have not applied for a paediatric PRV for RC220 as a cardioprotective anticancer treatment, we most certainly can do so in the future. There is more than one way to get the cat out of its skin.
Ann: FDA RPD Designation Granted for RC220 Bisantrene, page-43
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