Lead: STAT reported criticisms around the FDA’s recently proposed “plausible mechanism pathway,” a regulatory concept intended to streamline approval of personalized, small‑batch gene‑editing therapies. The debate intensified after Baby KJ’s individualized CRISPR therapy demonstration and a subsequent NEJM paper outlining a possible approval route. Commentators including policy analysts and clinicians argued that the pathway, while designed to scale individualized medicines, raises questions on evidentiary standards, manufacturing burden, and payment models. The STAT piece cited concerns about operational feasibility given the time and resource intensity required to develop single‑patient products. Regulatory and industry stakeholders now face pressure to clarify guardrails—safety monitoring, post‑market surveillance, and reimbursement frameworks—to determine whether the pathway can deliver more Baby KJ‑type therapies ethically and at scale.