people might be interest in the FDA in discussion with Trial design.
I see many comments about design of trial and hence gee they got tha that design wrong...yet it is my belief that the FDA in involved in discussion with companies about their design of those trials (but have a non binding disclaimer about that advice) , hence FDA going back on their word, or changing the goal post,
not sure if i have the right reference document , there are so many to choose from
https://www.fda.gov/media/130897/download
Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-670
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