Situation: NDA submission and an FDA Advisory Committee meeting for a pain and addiction product

The Success: We supported a client’s successful FDA Advisory Committee Meeting regarding a pain/addiction product for which we prepared the entire NDA submission. To assist the client with their meeting, we:

• Created more than 100 new displays to support core and backup slides
• Proposed a new ad hoc analysis which was used in the core presentation and directly addressed some FDA concerns
• Provided on-demand analyses leading up to and during the meeting

For the 4 questions posed, the Advisory Committee gave a majority favorable finding for all of them. There was also a formal discussion point regarding potentially critical application deficiencies, and the Advisory Committee deemed all of them not-critical.