...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: What would a success NR look like?

 

"So, back to that primary endpoint. Is that endpoint sufficiently ambitious in A's trial to assume that it being met is strong evidence of overall success?"

Yes. This is a high-risk population. As far as I know of, no CVOT in a population of diabetic patients with recent ACS has shown MACE reduction. EXAMINE and ELIXA both failed. If BETonMACE shows significant MACE reduction in this high-risk population, it will be huge. The AHA 2018 poster indicated that "With an assumed primary event rate of 7 per 100 patient years in the placebo group, the study has 80% power to detect a 29% reduction in MACE with ABL (or 50% power to detect a 24% reduction) with 2400 patients and an average exposure of 1.5 years." So most likely if the %RRR is significant, BETonMACE will have achieved a 24% or better RRR. The %RRR could still be a bit lower and still be significant. But hopefully it is much higher! So a top-line news release indicating that BETonMACE achieved the primary endpoint without revealing a %RRR........I'd be expecting anywhere between 15% and 50% RRR. Hopefully on the higher end!

BearDownAZ

Share
New Message
Please login to post a reply