BioCentury reported that Sydnexis received a complete response letter (CRL), a regulatory setback that staff and commentators say underscores growing concerns about FDA transparency and shifting evidentiary expectations. The company’s CRL and subsequent coverage prompted calls for more public advisory‑committee review to clarify regulatory requirements. The coverage frames the CRL as an example industry leaders point to when arguing for clearer FDA communication on data standards and endpoints. Regulatory affairs teams and corporate counsel will likely re‑examine submission strategies and the benefit of public meetings to preempt surprise requests during review.