RE: RNS13 Aug 2024 07:11
If the results of these upcoming pre-clinical experiments are positive, this could open an avenue for approval without extensive human clinical studies. In conditions where controlled clinical studies cannot be conducted, a drug could be approved by using pre-clinical studies simulating the intended use. As a widely used and well tolerated drug with a large amount of human exposure, interferon beta could potentially qualify as such a drug. Previous examples of such approvals also relate to defense, where the investigational drug cannot be tested in humans in the desired indication, but is proven to be safe in man while the efficacy is proven based on the mode of action and pre-clinical studies.