9) TMT/IBP
Abstract
Transformational Medical Technologies (TMT)/Intracellular Bacterial Pathogens (IBPs) - Upon Milestone A approval, TMT will advance experimental broad-spectrum drug candidates against bacterial diseases such as anthrax and plague through the Technology Development phase. TMT will initiate and complete Phase I clinical studies, where drug candidates are introduced into humans and early evidence is gathered on drug safety. TMT will conclude the TD Phase by completing all activities associated with Phase 2 clinical studies where drug candidates are evaluated for efficacy. The results of the TD 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, 2012
- Source ID
- ad2fb0338a90b8d3cf91c232609781c0