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NExT Application Resubmission

NExT applicants whose submissions were not accepted to the program on the first attempt are allowed one resubmission of the original application.  A resubmission is defined as a concept within a NExT application that follows the same idea (e.g., disease target, cancer indication, chemical matter, series, approach to the advancement of the therapeutic) and is not substantially redesigned.

The resubmission guidelines for the NExT Program are based around the NIH policy notices. Please see NOT-OD-18-197 (Application Submission/Resubmission Policy) and NOT-OD-12-128 (time limit of 37 months for resubmissions).

  • A resubmission can follow a competing new application that was not selected for award.
  • Only one resubmission of a competing new application are accepted.
  • All resubmissions are required to include a completed resubmission summary (2 page max) that addresses all of the bulleted feedback from the first review.
  • Resubmissions that are unsuccessful will have a 37-month waiting period before the idea, concept and/or approach constitutes a new application. This new application must not mirror the original document or the resubmission document. It must incorporate substantial* changes that address ALL prior reviewer comments and feedback with new supporting data.

*Substantial changes include, but are not limited to: i) a fundamentally different approach such as a new indication that is supported by new data for that indication; ii) new data generated and submitted that has improved the therapeutic; iii) advancement (supported with data) of the project to a new stage of drug development (e.g., a chemical hit is now in lead optimization or an in vivo effect has been demonstrated with the lead asset)

Instructions

Application resubmissions follow the same application deadlines process as new NExT applications. Some notable difference are outlined below.

The resubmission should include the following: 

  1. A Resubmission Summary must not exceed 2 pages. Please use the provided template (Resubmission Summary).
  2. Explain how the application has been modified and strengthened.
  3. Respond to the comments and recommendations from the scientific reviews. Address any disagreements with reviewers’ comments.
  4. Applicants are encouraged to submit an amended version of the original concept application to highlight substantial scientific changes.
  5. The amended application should follow the current “NExT Application Instructions” and not exceed 5 pages.
  6. Substantial scientific changes must be clearly marked with underlining. However, if the changes are so extensive that essentially all of the text would be marked, explain this in the Resubmission Summary.

For Multi-Agent Clinical Development Proposals, the amended application should follow the Multi-Agent Clinical Trial Proposal instructions, and should not exceed 3 pages per agent.

  • Updated:

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