The goal of this Funding Opportunity Announcement (FOA) is to support lead optimization and preclinical development of new therapies for diseases within the mission of the NIDDK with the SBIR program.
SBIR Phase I projects under this FOA supportpreliminary steps in the process for lead optimization
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or preclinical development of therapeutics.
SBIR Phase II supports lead optimization and preclinical development of lead candidates, and projects must be sufficiently advanced such that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of a SBIR Phase II or IIB project.
Applications are expected to have defined Milestones and Timelines detailing how the project will move forward with identified key Go / No Go decision points.