Two reports surfaced about Corcept Therapeutics’ failed submission for a Cushing’s syndrome drug: the company received a complete response letter, and the FDA stated the agency had flagged serious concerns before the application was filed. Corcept disputes the characterization, but the released documents show the agency had communicated issues that ultimately led to the rejection. Coverage includes the FDA’s explanation that earlier communications raised questions that could have been addressed prior to submission, and reporting that Corcept proceeded despite warnings about significant review risks. The episode spotlights sponsor–agency interactions, the importance of pre‑submission alignment, and potential commercial repercussions for late‑stage rare disease candidates. For regulators and R&D teams, the episode underscores the need for clear, early dialogue and the risk of misaligned expectations when companies proceed to filing without resolving known deficiencies.