CDrucker - previous phase 2 covered a lower range (under 500) , phase 3 is geared towards Very high (500 mg/dL or higher). In regards to expanded label I'd guess they'd need to run another trial (hopefully not an outcome like AMRN had to do for their upcoming Dec FDA Adcom) and then apply for expanded label). The high trig population in US is (from what I remember) 3 million to 6 million but china opportunity is huge (see below for 4Q call)
"I thought I would point out some key differences and advantages to the design of our TRILOGY studies as compared to our Phase 2 program. As I mentioned, we expect a total of approximately 500 patients to complete the two TRILOGY studies. And there are significant differences in the clinical profile of these patients compared to those who completed our Phase 2 studies." https://seekingalpha.com/article/4272297-acasti-pharma-inc-acst-ceo-jan-dalvise-q4-2019-results-earnings-call-transcript
"China is actually the third largest pharmaceutical market in the world with an average compounded annual sales growth rate of approximately 20% over the last 10 years. In addition let me remind you that China represents an important market for Acasti given the high prevalence of hypertriglyceridemia and the need for an effective safe and efficiently absorbed drug for the treatment of cardiometabolic related diseases"
In the new report, Earl S. Ford, MD, of the CDC, and his colleagues looked at a nationally representative group of 5,610 people 20 and older. They found that 33.1% had triglyceride levels above 150 mg/dL, while 17.9% had levels above 200 mg/dL, 1.7% had levels of 500 mg/dL or above, and 0.4% had levels higher than 1,000 mg/dL https://www.health.com/cholesterol/americans-high-triglycerides
Approximately one-third of the US population has elevations in circulating triglyceride levels [1, 2]. Most of these elevations are mild to moderate in nature, and the pathophysiology involves hepatic overproduction of very low?density lipoproteins (VLDLs), the principal triglyceride-carrying lipoprotein circulating in the fasting state [3, 4]. A subset of patients have “very severe hypertriglyceridemia,” defined by the Endocrine Society as serum triglyceride concentration ≥2000 mg/dL (22.6 mmol/L) [5]. In addition to VLDL overproduction, the pathophysiology of very severe hypertriglyceridemia involves defective triglyceride clearance due to either saturation or dysfunction of the enzyme lipoprotein lipase (LPL), resulting in accumulation of chylomicrons and VLDLs [3, 6, 7].
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