Acasti Pharma: Another Fish Oil Derived Product Nearing The Market [Seeking Alpha]
Last acasti pharma, inc earnings: 2/14 08:00 am
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US:NASDAQ Investor Relations: acastipharma.com/investors
Acasti Pharma: Another Fish Oil Derived Product Nearing The Market Acasti Pharma Inc. ( ACST AMRN Acasti’s current trial situation and catalysts Top-line data from the two ongoing phase 3 trials is expected by December 2019 and January 2020, respectively. Full data readout will be in March 2020. If phase 3 readout is successful, the company expects to file NDA mid-2020. The company recently completed 100% patient randomization in its ongoing TRILOGY 1 and TRILOGY 2 phase 3 trial programs of CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG). The phase 3, multi-center, multi-national, placebo-controlled, randomized, double-blind trial programs will assess the safety and efficacy of CaPre 4 g daily dosage in patients with severe HTG. Primary outcome is the percent change in fasting triglyceride (TG) levels from baseline, in patients with fasting TG levels =500 mg/dL and =1500 mg/dL (=5.7 mmol/L and =17.0 mmol/L). Several exploratory outcomes will also be
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SEC Filings
- 12/4/20 - Form 8-K
- 11/16/20 - Form 8-K
- 11/16/20 - Form 10-Q
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