Takeaways From Our Well-Attended NYC Dinner

研报英文原文证据摘录

Takeaways From Our Well-Attended NYC Dinner

e approaching the maximal MACE benefit

where mgmt estimates ~90-95% of the separation of placebo occurs by the 2-year mark. As

such, understand that if the study were not stopped and continued to YE27 the MACE benefit

achieved is unlikely to change from the 2-year point, but the number of total events will have

increased so that there is more power to assess the separation from placebo.

What are the stopping criteria for interim? To start, it is important to first make clear that NAMS

can provide the guide rails for the DSMB about how to make decisions regarding the interim

analysis, but ultimately it is the DSMB which has discretion for how to proceed. Accordingly, the

1Q27 decision will indicate what decision has been made, but they will not disclose the reasoning

for that decision. Thus, there are multiple potential reasons (both positive and negative) which

may dictate why the study may or may not need to continue. While mgmt noted that a mortality

benefit has not yet been observed in prior outcomes studies, if there were evidence of a mortality

benefit mgmt indicated that the DSMB would likely want the study to continue in order to

demonstrate that with more statistical power. On the other side, it is possible the DSMB could

decide to continue the study if low rates of a new safety event were observed, and they want

to see whether it was related to obicetrapib. However, we believe there is low likelihood of this

considering the totality of the large safety database accumulated for obicetrapib and the dozen

safety analyses that have already been completed. Altogether, NAMS disclosed the below details

regarding the interim analysis trigger and the criteria provided to the DSMB to inform interim

analysis decision-making.