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Message: Apabetalone

Koo wrote: "...is Apabetalone designed as a standard of care medication such as an aspirin and a statin?"

From a clinical trial perspective, apabetalone is being tested in patients with very high-risk for cardiovascular disease (CVD), such as diabetics with low HDL in BETonMACE and patients with chronic kidney disease in future renal trials. So if these trials prove successful for lowering MACE in these high-risk patients, then I expect the NDA/MMA filings with the FDA/EMA to focus on marketing/commercialization for these high-risk patients. So apabetalone is on a path to potentially be a standard of care (SoC) for these high-risk patients. Of course, the degree of MACE reduction shown in trials will impact the likelihood of apabetalone becoming a SoC. If it only has a modest MACE lowering effect, then there will likely be less prescribing by physicians.

As for apabetalone becoming an SoC for the general population........I have two trains of thought here. 1) Apabetalone will first need to be shown to be effective in clinical trials in patients with a moderate CVD risk; 2) Once approved by the FDA/EMA, I'm not 100% sure but even if #1 isn't done yet doctors may be able to prescribe to anyone. However, I think #1 is the more likely route to being accepted as a SoC for a more general low to moderate risk population and not just high-risk population. However, again the likelihood of becoming a SoC depends on the MACE risk reduction shown in trials.

BearDownAZ

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