The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD
Suven Life Sciences completed enrollment of patients to the phase-2, PoC clinical study of samelisant (SUVN-G3031) for the treatment of narcolepsy with or without cataplexy in USA and Canada
The inspection concluded with no observation (FDA-483) issued.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
This multi-centre study (sites in the US and Europe) comprising about 387 patients is likely to be completed in about 36 months and the topline result is expected by the end of 2024
Subscribe To Our Newsletter & Stay Updated
