De-risking the NDA Process: Analysis, Strategy, and Cross-Disciplinary Expertise.
The Sponsor had developed a game-changing therapeutic with an application. in ophthalmology—a product that could have a tremendous impact on patients the world over.
The clinical studies were complete, and the rush approval was on. The Sponsor came to Premier Research for assistance preparing for the Pre-NDA meeting. However, during our first consultation we uncovered issues that could impact their NDA success, and likely create issues during FDA review. The Sponsor soon expanded the scope of their request.