Situation: Small virtual biotech company was completing a four-year, global Phase 3 study in diabetes. The study was conducted through a series of outsourced providers and this, along with several internal management transitions, led to limited internal clinical and regulatory expertise, as well as minimal understanding of the overall strengths and limitations of the NDA package.
Value: NDA Gap Analysis was instrumental in rescuing a study that suffered from inconsistent oversight. The study results were not sufficient for NDA filing. However, the client was able to raise $7.5 MM based upon the study results to support additional clinical studies.