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提交了一本簡報，以幫助指導TFF TAC的臨床開發路徑的下一步。在審核簡報後，FDA認爲減輕或預防他克莫司相關的毒性，同時不會危及肺移植物是一種重要的治療益處，並提供了有建設性的反饋和有價值的指導，以制定TFF TAC的推進路線圖。根據這些反饋，公司預計TFF TAC的臨床推進的時間表和預估成本不會發生重大變化。
譯文內容由第三人軟體翻譯。