Preclinical Stage and Clinical Stage evaluation criteria will be published at a later date.
The degree to which the submission provides a credible approach to combining an RNA vaccine and microneedle patch into a product that delivers consistent intradermal doses under acceptable storage conditions for clinical use. The degree to which the submission demonstrates feasibility of the proposed combination product, including supporting evidence.
The degree to which the submission provides a realistic and sufficiently articulated plan toward completing Phase I clinical evaluation of a patch-based RNA vaccine combination product, including defining appropriate functional immune assays and associated success criteria, aligned with FDA requirements for an Investigational New Drug (IND) application.
The degree to which the submission provides an appropriate plan for effective engagement with the FDA, and to effectively compile evidence for a submission of an IND application. The degree to which the submission demonstrates an approach to assess and mitigate risks associated with product development.
The extent to which the submission details plans for consistent manufacturing for clinical evaluation, including any preliminary manufacturing data that indicates Phase I clinical trial readiness.
The extent to which the submission demonstrates the entrant has sufficient expertise and capabilities to usher the product through a Phase I clinical trial, including access to necessary intellectual property. The degree to which the submission identifies any additional capabilities that may be required and provides a clear approach to addressing those needs.