Aug. 27 at 6:10 PM
$OKYO
Given the Fast Track status, regulatory advice re Phase 3 design from the FDA can come through formal End-of-Phase 2 meetings, which typically follow topline data readouts.
Since topline data were announced in mid-July 2025, OKYO could realistically request this meeting immediately thereafter.
Therefore, the FDA's guidance could plausibly arrive within weeks to a few months, potentially as early as September 2025, depending on scheduling
