Re: CABG/COG (as opposed to CABG/HR)
You raise some good questions, but I don’t think anyone has definitive answers.
If Ovation does decide to pursue CABG/COG (doubtful, IMO, but it can’t be ruled out entirely), one or more phase-2 studies would probably be needed to refine the efficacy endpoints and treatment protocols.
This is in sharp contrast to CABG/HR, where the endpoints and protocols are well-understood and Ovation ought to be able to secure an SPA for a phase-3 trial without having to run any new phase-2 studies.