TFF Pharmaceuticals Announced A Regulatory Update On Its TFF TAC Clinical Program Following Its Recent Interaction With The FDA, Company To Provide More Detailed Regulatory Update In 3Q 2024
TFF Pharmaceuticals Announced A Regulatory Update On Its TFF TAC Clinical Program Following Its Recent Interaction With The FDA, Company To Provide More Detailed Regulatory Update In 3Q 2024
In April 2024, the Company submitted a briefing book to the FDA to help guide the next steps in the clinical development pathway for TFF TAC. Following its review of the briefing book, the FDA concurred that mitigation or prevention of tacrolimus associated toxicities without placing the lung allograft at risk will be an important therapeutic benefit and provided constructive feedback and valuable guidance on the roadmap for advancement of TFF TAC. Based on this feedback, the Company does not expect a significant change to either its timelines or the estimated costs associated with the clinical advancement of TFF TAC.
2024年4月，公司向FDA提交了一本简报，以帮助指导TFF TAC的临床开发路径的下一步。在审核简报后，FDA认为减轻或预防他克莫司相关的毒性，同时不会危及肺移植物是一种重要的治疗益处，并提供了有建设性的反馈和有价值的指导，以制定TFF TAC的推进路线图。根据这些反馈，公司预计TFF TAC的临床推进的时间表和预估成本不会发生重大变化。