Foresee Pharmaceuticals Co., Ltd. received notification from FDA that Foresee may proceed with the Phase 2/3 clinical trials of FP-025 in patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome (ARDS). Proceed with the proposed Phase 2/3 clinical trials. Current development status: a. Submission for approval/Approval/Disapproval: Free to proceed with Phase 2/3 clinical trials – a randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with COVID-19 associated ARDS. For the Phase 2 study, approximately 100 patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: FP-025 100 mg BID, FP-025 300 mg BID, or placebo BID. The primary efficacy endpoint is the proportion of patients alive and not on a ventilator on Day 28. Future operating goal, if obtained approval from competent authority: Proceed with Phase 2/3 clinical trial.