The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission. This webinar will cover:
- Goals for your EOP2 meeting
- What does it mean to be phase 3 ready?
- Developing the right questions to obtain clarity from FDA
- Timing considerations
- Common themes in FDA feedback Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from this webinar.