Efficacy Endpoint UncertaintyReliance on plaque removal as primary evidence in the subcutaneous filing creates uncertainty that measurable cognitive improvement will follow without confirmatory functional evidence.
Regulatory And Post‑approval ObligationsApproval based on surrogate plaque endpoints could prompt additional regulatory requirements or confirmatory trials, extending uncertainty around real‑world clinical benefit.
Safety Risk — Brain Swelling (ARIA)Subcutaneous formulation may not substantially reduce the brain swelling risk observed with intravenous dosing, limiting any improvement in the therapy's overall risk–benefit profile.