Cabel,

The CKD and cognition sub-studies are not the primary endpoints in BETonMACE. Because of this, a Phase 2 confirmatory efficacy and safety trial is appropriate before proceeding to Phase 3, in my opinion, for them to first confirm as a pre-specified primary endpoint clinical trial. I am no expert in this arena, so I'm not saying it is impossible for them to go straight to Phase 3. But the more they change the patient population and endpoint from the BETonMACE sub-studies, the more burden of proof there is first perform a confirmatory pre-Phase 3 trial before going to Phase 3. As for trial length, that is highly dependent on the patient population and the endpoint that they are chasing after. Usually Phase 2 trials are much shorter than Phase 3 trials. I've also responded to you on this similar issue twice before here and here. 

BearDownAZ