1. Uses same API/PK/PD and as part of reformulation program likely preclinicals behind the scenes indicating potential efficacy. Tox studies are still in progress, so it os no endorsement.
2. 90 days
3. Not aware this is a reason to deny ODD approval, I am sure there have been other AML treatments with ODD in the past, you can check FDA ODD list.
4. EMA ODD (in progress) and BTD per AGM presso (IND submission?)
Ann: US FDA Orphan Drug Designation Awarded to RC220 Bisantrene, page-98
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