CASE STUDY – Rare Disease Regulatory Strategy
An early stage pharmaceutical client acquired an asset with Phase 2B cardiovascular data and a goal to repurpose the drug for a rare disease indication. The client required regulatory and clinical expertise to support a type B meeting request with the FDA.
NGT consultants, through analysis of the cardiovascular clinical study reports, provided feedback on the feasibility of applying the CV data to the therapeutic area of interest. Our regulatory strategist developed a roadmap for the rare disease indication.
First-line regulatory strategy was created. A product development plan was developed that redirected the effort towards a viable rare disease regulatory pathway.