Sample NIH Summary Statement: Impact Score 33 - A Competitive But Unfunded Application

SBIR Grant Writers · February 27, 2026

An impact score of 33 places this application in competitive but uncertain territory. Depending on the NIH Institute and the fiscal year, a 33 may fall just inside or just outside the payline. This is the score range where the difference between being funded and needing to resubmit often comes down to factors beyond the applicant's control - but the summary statement provides a clear roadmap for improvement if resubmission is needed.

Note: This summary statement is entirely fictional. All company names, investigator names, and project details are fabricated for educational purposes.

The Application at a Glance

This fictional Fast-Track SBIR application proposed a lipid nanoparticle (LNP) delivery system for gene therapy targeting inherited retinal dystrophies. The technology enables delivery of full-length therapeutic transgenes up to 12 kb, overcoming the packaging limitations of currently used AAV vectors.

The Split Vote

The Resume describes a "split among committee members" - the most common dynamic in mid-range scores. The split centered on whether the choice of LNP delivery over established AAV vectors was a strength (overcoming known AAV limitations) or a risk (abandoning a proven platform for an unproven one). This kind of strategic disagreement is characteristic of genuinely innovative applications that push beyond established approaches.

The Reviewer Scores

Reviewer 1 - The Cautious Assessor

Reviewer 1 scored Approach at 5 - the key score driver for this application. The concerns were specific: manufacturing scale-up, GLP toxicology study design, compressed IND timeline, and 16-week expression durability. These are all addressable but require real work, not just rewording.

Reviewer 2 - The Encouraging Reviewer

Reviewer 2 was more optimistic about the approach but flagged the team's lack of IND-enabling experience. The Investigator score of 3 reflects a real concern that the PI has not previously led a program of this regulatory complexity.

Reviewer 3 - The Balanced Reviewer

Reviewer 3 gave consistently strong scores across the board. This reviewer viewed the LNP approach as genuinely innovative and the risks as manageable. The Approach score of 3 reflects minor concerns about manufacturing detail rather than fundamental design flaws.

What Drove This Score

The application had clear strengths that all three reviewers acknowledged: the unmet clinical need is compelling, the LNP platform enables gene therapy for conditions that AAV cannot address, and the preliminary data showing 16 weeks of photoreceptor expression are encouraging. These elements should be preserved in any revision.

The weaknesses were concentrated in two areas:

• Manufacturing and regulatory readiness. Two reviewers flagged insufficient detail on GMP manufacturing scale-up, the GLP toxicology study design, and the IND filing timeline. For a Fast-Track application that promises IND-enabling studies, this level of detail is expected.
• Team experience gap. Two reviewers noted the PI lacks IND-enabling experience. The resubmission should either add a regulatory affairs consultant to the team or demonstrate that the PI has taken concrete steps to build this capability.

Resubmission Strategy

If this score falls outside the payline, the resubmission should focus on three things: a detailed CMC development plan with specific manufacturing milestones, a fully described GLP toxicology protocol, and the addition of regulatory expertise to the team. New data on expression durability beyond 16 weeks would also significantly strengthen the application. For detailed guidance on the resubmission process, see our article on NIH SBIR Resubmission Strategy.

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