Core Insights - Tharimmune, Inc. has received positive feedback from the FDA regarding its lead clinical asset, TH104, which is a nalmefene buccal film aimed at mitigating respiratory depression caused by potent opioids [1][3][5] Regulatory Developments - The FDA concurred with Tharimmune's pharmacokinetic simulation modeling plan, which is essential for advancing TH104 as a prophylactic treatment [3] - The FDA's feedback is expected to de-risk the TH104 program and aligns with the company's strategy for a 505(b)(2) New Drug Application (NDA) submission [3][5] Operational Milestones - Tharimmune is set to initiate a comprehensive Chemistry, Manufacturing, and Controls (CMC) plan, which is crucial for scaling production and ensuring the quality of TH104 [4] - The company has previously conducted a positive pharmacokinetic simulation analysis for TH104, reinforcing its potential as a superior treatment option for military personnel and first responders [5] Product Advantages - TH104 is designed for non-injectable, rapid absorption and self-administration, making it advantageous for first responders in high-risk environments [5] - The simulation analysis indicated that TH104 could achieve protective concentration levels within approximately 30 minutes post-dose and maintain protection for about 24 hours, which is a significant improvement over existing options like naloxone [7]