Tim Lugo's questions to Vistagen Therapeutics (VTGN) leadership • Q1 2025
Question
Tim Lugo from William Blair asked about FDA discussions regarding self-administration versus HCP-administration for fasedienol and its potential impact on the label, as well as the timeline for the Phase IIb trial for itruvone in Major Depressive Disorder (MDD).
Answer
Chief Executive Officer Shawn Singh explained that HCP administration in current trials is for consistency and is not expected to alter the intended on-demand, patient-administered label. For the itruvone MDD trial, Singh clarified that the protocol is being finalized with KOLs for submission to the FDA before year-end, with the trial itself not expected to start in the current calendar year.