The FDA’s now reviewing their big drug application, with a decision due by April 2027. That’s not just a checkbox; it’s a potential gateway to a $1B US market. Even better? Their losses are shrinking, and they’ve got SEK 40M in cash + a SEK 50M safety net. What’s behind the turnaround? Distributor sales surged 27%, and Germany; their key market; is finally stabilizing after a rough H1. It’s not hype. It’s execution. If the FDA says yes, this could be the quiet pivot that turns Sedana from a struggling biotech into a player worth watching.