7) TMT/EID FLU
Abstract
Transformational Medical Technologies (TMT)/Emerging Infectious Diseases (EID) - Upon Milestone A approval (planned for 2Q FY11), TMT will advance experimental broad-spectrum drug candidates with an Investigational New Drug (IND) application accepted by the Food and Drug Administration (FDA) through the Technology Development (TD) phase. In order to advance drug candidates, TMT will 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
- cd1e7ecaec7c2034b25a6dd64324bf58