Clinical Data StrengthThe cognitive and behavioral changes data at 1 year in the Phase 1/2 OLE are impressive, so it should be long enough to demonstrate a separation.
Investor ConfidenceThe new open-label extension (OLE) data on more patients and for longer duration is very encouraging and should help drive investor confidence that Stoke has the right dosing regimen for the pivotal study.
Regulatory SuccessRegulatory alignment across 3 agencies for one study - especially using the same efficacy measures as the Phase 1/2 study - is never easy and clearly a positive for the company.