Part of the FDA approval process requires a company to show that...

Part of the FDA approval process requires a company to show that they have manufacturing processes in place that can produce their product at commercial scale whilst still meeting GMP. This also includes the FDA inspecting the facility and manufacturing process themselves.

On a normal timeline, companies generally do this in the Phase 3 trials. Given the accelerated approval timelines and the adaptive Phase 2/3 approach that PAA has been given by the FDA, these need to be put in place now. If they get good interim results at the Week 24 readout, the FDA will start reviewing everything else, including the manufacturing.