- Positive FDA feedback allows Tharimmune to proceed with TH104 without additional clinical trials.
- Tharimmune appoints James Gordon Liddy as strategic advisor, bringing expertise in counter-terrorism.
- Strategic appointment and regulatory pathway could accelerate TH104's development timeline.
Tharimmune, Inc. (THAR, Financial), a clinical-stage biopharmaceutical company, has announced the appointment of James Gordon Liddy, a former US Navy SEAL Commander and expert in counter-terrorism, as a strategic advisor. This significant addition comes after positive feedback from the U.S. Food and Drug Administration (FDA) regarding the company's prophylactic treatment, TH104.
TH104 is designed as a temporary prophylaxis against respiratory and central nervous system depression caused by high-potency opioids, such as weaponized fentanyl. The FDA indicated that no additional clinical trials are necessary before submitting a 505(b)(2) New Drug Application (NDA), allowing Tharimmune to leverage existing data and potentially accelerate the development timeline.
James Gordon Liddy brings extensive experience in national security and preparedness, having held key positions including Senior Advisor to the Director for Strategy in the Office of the Assistant Secretary of Defense and Chief of Plans and Policy for the United States Special Operations Command. His expertise aligns with Tharimmune's mission to advance TH104 for military personnel and first responders exposed to opioid threats.
The strategic appointment of Mr. Liddy and the regulatory feedback from the FDA are pivotal for Tharimmune's efforts to fulfill critical unmet needs in opioid exposure treatment, positioning the company to potentially secure government contracts for TH104.
