Traws Pharma announces receipt of FDA guidance on tivoxavir marboxil

Traws Pharma (TRAW) announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration. The FDA provided feedback on development paths for potential approval of tivoxavir marboxil for bird flu and seasonal flu, including on the use of the Animal Rule. The Animal Rule is intended to provide a path to approval in situations when human clinical studies would be unethical or impractical.