Re: Win or lose....one thing we know for sure
in response to
by
posted on
Aug 31, 2019 06:00PM
"With such findings, the FDA may an NDA for 208 in combination with Rosuvastatin. As of March, 2017, Resverlogix holds the patent in the US for the use of Apabetalone in combination with Rosuvastatin."
Yes, the potential for the rosuvastatin subgroup to show a greater %RRR for MACE reduction than the combined statin group and atorvastatin subgroup is both possible and exciting. However, it would be so much better for BETonMACE to meet the primary outcome with the combined statin group too, even if it is a more modest %RRR than for the rosuvastatin subgroup. The FDA is not very keen on reliance on subgroup data for NDA applications. Recall, that Novartis ran into a roadblock with canakinumab NDA by trying to rely on CANTOS subgroup data.
BearDownAZ