The FDA accepts VO2Peak as a clinically relevant endpoint for cardiovascular trials.
The FDA doesn't tell you what is their preferred measure, they just tell you if the approach you are taking is acceptable or not. You ask questions like: "Does the FDA agree that X is an acceptable endpoint for Y..." and the FDA either says yes or no.
VO2Peak vs VO2Max, page-11
-
- There are more pages in this discussion • 13 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
