Re: What would a successful BETonMACE Top-Line Data Announcement Look Like?
posted on
Aug 12, 2019 03:27PM
I have been thinking about the possible release of results being only that the desired top line results were achieved or not.
I have also remembered that the setup of the BetOnMace trial was initially thought to be best if it included only Crestor because of the synergistic effect of Apabetalone and Crestor in the Phase II trial whereas no such synergy was seen with Lipitor. I also remember that apparently the FDA wanted Lipitor to be included in the trial and so it was ; but the trial was then set up with two subgroups of Crestor and Lipitor so that they could be part of the original design rather than having to be looked at on a Post Hoc basis as was the case of the phase two Failure to achieve expected results where the better than expected results for Crestor patients were opposed to very disappointing results in the case of Lipitor patients and blended results were noted as a Failure and the Post Hoc analysis was pooh-poohed as just Post Hoc and not worth considering.
I am hearing some people worry about the expected results not being a success on the blended basis, although we in general expect the results to be successful.
If we are faced with a failure on the top line blended results the company can quote the possible success on the Crestor sub group and I would expect them to actually say so on the first News release rather than just the overall results in the case of an overall failure; although I am hoping for an impressive success.