TFF Pharmaceuticals submits briefing book to the FDA for TFF TAC development

TFF Pharmaceuticals announced a regulatory update on the Company’s TFF TAC clinical program following its recent interaction with the U.S. Food and Drug Administration , FDA.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. “The initial feedback from the FDA on the TFF TAC clinical program has provided us with additional clarity on how we can continue advancing this innovative product towards registrational testing,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “Over the next several weeks, we expect to receive additional guidance from the FDA, which should allow us to provide a more detailed regulatory update on the program in the third quarter of 2024.”