Regulatory ApprovalThe plan to seek FDA feedback on the design of the registrational study remains unchanged, and the recent agreement between Alector and the FDA on including plasma PGRN as a co-primary endpoint in the ongoing Ph3 study in FTD-GRN is seen as positive for PASG.
Safety MeasuresBoth the Independent Data Monitoring Committee and the FDA have agreed that the next patient can be dosed as planned with additional safety monitoring.
Therapeutic PotentialThe prevention of neurodegeneration is suggested by a smaller increase in plasma NfL levels in treated patients compared to untreated patients.