There is another plausible alternative!

Assuming we also had significant  improvement in kidney function ( we dont know the results yet but the FDA does) and we know there was improvement in MACE and cognition in these patients with diabetes and impaired kidney function,;I knowof no other drug that is safe and has comparable therapeutic effects in these three domains,. IMHO the FDA would be hardpressed not to grant approval for this specific indication with a caveat there is a second confirmatory ie phase four trial.