Ann: PAR to present at NWR Healthcare Conference, page-22

Dose finding arm of phase 3 stage 1, not including our optimal dose…... Well it appears our pre existing data on it is so sound the fda we were in “agreeance” to complete the stage 1 without it and then compare these lower doses against our phase 2b data generated in 2018/19and 2022/23. One must conclude the pre determined metrics for safety and efficacy were also ran by the fda. No need for peer reviews. 2mg gets up and our 2mg data is quality (phase 3 trial level quality).

I’m with Denial, fda now taking the “complete” submission from the adrenal gland monitoring and pre existing safety data and getting comfortable with what level of monitoring is required for stage 2 of the phase 3. Clear trial changes to be ratified. Monitoring to allow the fda to feel comfortable on:
1. Safety, and
2. Tracking DMOAD characteristics
3. efficacy (which we know is quality).

Paul presented well. He sounds like he has been working his backside off. Removing Paul from the presentation, if Margot Robbie presented the data, the earth would tilt on its axis. Seriously impressive