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Message: Breakthrough Therapy Designation Application

"Why do you think the placebo group went up from baseline also,..?"

Probably because when these patients checked in they were very sick (low-HDL, recent ACS, diabetic, and 70 or older) and were then placed on the well managed standard of care. Placebo group in the basline <22 seemed to have benefit at 52 weeks, but then declined afterwards. This is where the apabetalone divergence appeared. Apabetalone group continued to increase, where there placebo leveled off and dropped. Perhaps there was a transient benefit in everyone due to common standard of care, but that had limited benefit in the long term for placebo patients while apabetalone continued to elicit benefit.

There are some interesting observations, but they are modest and underpowered.

Why did the placebo group w/ baseline <22 increase at 52 weeks?

Why was there little to no efffect of apabetalone in those w/ baseline >22

Why did the apabetalone group in the 22-25 subgroup tend to increase, while the apabetalone group in the >26 subgroup tend to decrease?

The effect of apabetalone in the MoCA 22-25 showed similar pattern of change as MoCA <22. If the study was larger and run longer, would there be a benefit of apabetalone in those w/ MoCA >22?

BDAZ

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