8) TMT/HFV

Abstract

Transformational Medical Technologies (TMT) Program/Hemorrhagic Fever Virus (HFV) - TMT will advance broad-spectrum or platform-based MCM candidates against viruses such as Ebola, Marburg and Junin through the Technology Development phase. TMT will complete preclinical evaluation to achieve IND status (as necessary) and 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 1 clinical studies. 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
9d1441973174313fafe64c669cc5de97

Tags

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Infectious Disease/Epidemiology

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