We also need to keep in mind that PAR will be very limited with...

We also need to keep in mind that PAR will be very limited with what they can ask the FDA since the new Type D meeting format is very limited since it is designed for quick turnaround. So my guess is they will only discuss one topic and include 2 or 3 questions, for example:

Topic 1: What structural endpoints would you consider satisfactory to obtain a DMOAD label?

Questions could include:
1. Would you consider resolution of BML and at least one synovial fluid based biomarker to be sufficient for a DMOAD label? or what do you consider to be acceptable structural endpoints for DMOAD?
2. Do you require any acceptable DMOAD structural endpoints to associate with pain and function outcomes for individuals, or can they be considered independent of pain and function outcomes.
3. Can these endpoints be included as secondary endpoints in a clinical trial, and if so, would it require only one P3 or two P3's etc