10) IBP
Abstract
Intracellular Bacterial Pathogens (IBPs) - Upon Milestone A approval, the program will advance experimental broad-spectrum drug resistant candidates against naturally occurring and genetically engineered biowarfare/bacterial agents such as Anthrax and Burkholderia through the ACD&P phase. The program will initiate and complete Phase I clinical studies, where drug candidates are introduced into humans and early evidence is gathered on drug safety. The program will conclude the ACD&P phase by completing all activities associated with Phase 2 clinical studies where drug candidates are evaluated for efficacy. The results of the ACD&P phase clinical studies will support a Milestone B decision to continue toward a New Drug Application (NDA) and FDA approval/licensure.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2014
- Source ID
- 4e269d26cc81a6e15bf8f476af5fc4a8