I would add that the discussion with a potential sponsor/investigator-led trial is absolutely new - and is likely how this PRV will be secured. Even RAC themselves are calling activities in this space part of their "paediatric AML program", so it's clearly under project management internally as yet another avenue that is being actively explored.
KOLs continue to validate bisantrene's importance and relevance, which further derisks the IP.
Ann: FDA RPD Designation Granted for RC220 Bisantrene, page-20
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