Jun. 4 at 12:03 AM
$VTGN
Here is how the baseline approach differs between palisades 3 and 4:
The Baseline Statistical Shift
PALISADE-3 Baseline Approach: The trial measured the change in a patient's self-reported anxiety using the Subjective Units of Distress Scale (SUDS) during a simulated public speaking challenge. However, it lacked a refined, tight adjustment for the exact level of distress a patient felt immediately before the investigational product was administered. This left the trial highly vulnerable to "measurement noise" and a massive placebo response (where placebo patients showed nearly identical SUDS point reductions to the fasedienol group).
PALISADE-4 Refined Baseline Approach: In May 2026, Vistagen updated the PALISADE-4 SAP to incorporate each participant's precise distress level immediately prior to dosing (pre-IP SUDS) as a formal baseline covariate in the primary efficacy analysis.
This locks in the pre-dose SUDS score as a baseline covariate to reduce noise.
