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

Author: Benzinga Newsdesk | June 24, 2024 07:10am

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.

Posted In: TFFP