The agency's answer included something the sponsor hadn't fully considered on its own: a baseline severity threshold that would meaningfully sharpen the trial's ability to detect a real effect. The study that resulted was smaller and faster, and it landed on a pivotal readout the agency had effectively already signaled it would accept. Whether that single meeting alone explains the program's eventual approval is hard to say with certainty plenty else had to go right too but the team was unambiguous that it changed the trajectory of everything that came after.
