Emily Chetty

Emily Chetty from Stifel asked for an update on the enrollment status of the PALISADE-4 trial and whether the company plans to announce its completion. She also sought details on the specific findings from PALISADE-3 that informed the operational refinements implemented for PALISADE-4.

Answer

President and CEO Shawn K. Singh confirmed that the company is on track for the randomized portion of PALISADE-4 and will announce the last patient's last visit, consistent with prior studies. Chief Operating Officer Josh Prince explained that PALISADE-3 showed a higher placebo response than PALISADE-2, leading to refinements like reinforced site training, strict protocol adherence, minimizing subject interaction, and leveraging audio recordings to mitigate placebo effects. Shawn K. Singh added that centralized recruitment was also a focus.

Emily Chetty asked for an update on the enrollment status for the PALISADE-4 trial and whether the company plans to publicly announce its completion. She also sought more details on the specific findings from PALISADE-3 that prompted the operational refinements, such as site retraining, for PALISADE-4.

Answer

Shawn K. Singh, President and Chief Executive Officer, confirmed that the company would announce the last patient's last visit for PALISADE-4, consistent with previous patterns, and is on track with prior guidance for top-line results. Joshua Prince, Chief Operating Officer, explained that PALISADE-3 showed a higher placebo response compared to PALISADE-2. This led to refinements like reinforced training for sites on protocol adherence, minimizing subject comfort, and strict adherence to scripts to mitigate placebo effect, leveraging insights from audio recordings and centralized recruitment.