Immedica Pharma AB: BLA 761211

We acknowledge receipt of your major amendment dated), which extended the goal date by three months.

We reserve additional comment on the proposed labeling at this time.

9. The adequacy of AEB1102 dosing in the context of initiating treatment via the subcutaneous (SC) route, without prior intravenous AEB1102 treatment, has not been characterized in patients with ARG1-D. Provide clinical data, either from an ongoing or planned trial, to support the dosing and safety (including immunogenicity) of initiating AEB1102 treatment via the SC route of administration.