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We will continue to evaluate the utility of the maximum allowed amount, and may revisit this alternative in future rulemaking

The commenter indicated that these differences risk limiting hospitals from adopting the procedure and thus hindering patient access

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Subcutaneous injection is the most common research-context format today, but no published human pharmacokinetic study has formally characterized subcutaneous AOD-9604 (this gap was specifically called out in FDA's December 2024 review)

Adjust dosages as necessary based on clinical judgment