Re: I think one major reason that,
in response to
by
posted on
Nov 02, 2019 08:54AM
Kip .... they did compare the various combinations, but albeit in sub-studies. I have a "beef" also, like you, with the FDA requiring both Crestor and Lipitor for the primary endpoint goals, for all of the many reasons discussed, as RVX had requested/attempted. But, the FDA apparently required both for their pathway to approval for this study, for whatever reasons. That would have been a home run, and near slam dunk had they hit the numbers and confidence interval, which were very close, judging from inferences that have been alluded to by RVX mgt (Don). Nothing we can do about that now, but hopefully it is part of the argument.
The data may show that apabetalone adds benefit to Lipitor users as well, with a nice safety profile, in addition to Crestor ... just as good as Crestor with a drop off that was a enough to drop the overall statistics below target. All speculation on my part, but it may not end up as bad as we "feel" after everything is digested?
My hope, in this case, if the numbers are good enough, and powered "enough" that they can make the case and move forward now with NDA, or at the least fast-track enough additional powering to get to the promised land. The clear benefit with Crestor, and the lesser benefit with Lipitor, along with safety profile, secondary endpoint results and promise, and the "current" FDA environment ... may possibly lead to a path that is sooner than later potentially ... "if' the data data data is "all that" ...
the numbers are the numbers, whether primary or sub-study, and are hopefully good enough to move forward quickly. It seems that we may be a LOT closer than anyone thought on Sep 30. But we will know a lot more after Nov 13, 16, 18 and Dec 6.
Hopefully we (RVX) can put the case together for moving forward, and/or partnering with a BP with clout and FDA experience/history/relationship to get this done soon.
All jmho