A toddler's brain is running out of time. Montana's new law offers a last shot.

Kris DeVault is watching his son Brody miss the most critical years of brain development. At three years old, Brody has creatine transporter deficiency (CTD), a rare genetic disorder that starves his brain and muscles of energy. He can’t speak, struggles to walk, and recently stood silently while fire ants bit his feet because he couldn’t communicate the pain. The neurological clock is ticking loudly; his dad knows the brain’s plasticity window for intervention is closing fast.

A potential lifeline exists at a small French biotech called Ceres Brain Therapeutics. Their experimental nasal spray is designed to bypass the CTD defect and deliver creatine directly to the brain. It has shown promise in mice and cleared a phase I safety trial in 48 adults, but CEO Thomas Joudinaud faces a brutal regulatory gauntlet. The drug hasn’t been tested in children or CTD patients, it’s not registered with the FDA, and the upcoming phase II trial is in France—out of reach for Brody. Standard expanded access isn’t an option.

That’s where Montana’s newly operational “right to try” law comes in. The state just finalized rules for an experimental treatment review board, which is set to review its first two applications in weeks. The law lets non-terminal patients access unapproved drugs that have cleared phase I, creating a potential bridge to Ceres’ treatment. DeVault is lobbying the FDA for a formal meeting to find a path, but Joudinaud is hesitant to sell the drug through a Montana clinic, fearing retaliation from federal regulators.

The gap between a desperate father and a cautious CEO illustrates the brutal friction in our drug development system. DeVault knows the drug is a gamble—it might not work, or it might be too late. But when your son can’t tell you he’s in pain, the abstract risk of regulatory disapproval feels like a luxury you can’t afford. The question is whether Montana’s legal framework can force a crack in a federal system designed for a timeline Brody simply doesn’t have.