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TUEs are granted for medically necessary treatments of approved drugs

However, the neuronal functions of AKAP11 and the impact of its loss-of-function remains largely uncharacterized

As cited in Sidari A, Hill E

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Kinnari Patel, Rockets president and chief operating officer, noted that this treatment option has substantial morbidity and mortality and may not be available in time for these children. RP-L201 holds the FDAs Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric, Fast Track and Orphan Drug designations