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Are you really ready for your end of phase 2 meeting?
January 25, 2020 @ 1:00 pm
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 attending this webinar.