The submitted package looks strong enough to clear the FDA's clinical-effectiveness bar. What's left is the softer stuff — Day-84 durability, tolerability, and the commercial ramp — not the core Q.
Praxis: Odds Favor Ulixacaltamide Approval in…
The submitted package looks strong enough to clear the FDA's clinical-effectiveness bar. What's left is the softer stuff — Day-84 durability, tolerability, and the commercial ramp — not the core Q.