It's more than just a Canadian company, there are several other drug candidates in the works and it also has a subsidiary named Psilocin Pharma Corp that works with University of Wisconsin for psychedelic therapeutics.
The Company is preparing along with its CRO, Pharm-Olam, the Investigational New Drug (“IND”) package to the U.S. Food and Drug Administration (“FDA”) for the proposed Phase 3 confirmatory clinical trial (“Phase 3 study”) to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection. As previously announced, the FDA recommended that the Company proceed directly into a confirmatory clinical trial. Also, the Company is updating its current IND with the FDA for Bucillamine, which will not only pave the way to proceed with the Phase 3 COVID-19 study but also the IND will serve as the foundation to pursue future programs with Bucillamine in infectious diseases and inflammatory and respiratory disorders. Revive aims to submit the FDA IND package in June 2020 and expects to obtain FDA acceptance to proceed to a Phase 3 study. The Company is also seeking to conduct a clinical study with Bucillamine in the treatment of COVID-19 in Canada and is preparing its pre-Clinical Trial Application (“pre-CTA”) package to Health Canada that will include data on the safety, efficacy, manufacturing process and clinical trial protocol of Bucillamine. The Company estimates to have feedback from Health Canada in June 2020 and expects to initiate a clinical study as soon as possible following receipt of regulatory clearance from Health Canada.
I don't think that is the case here. Trump love imported Drug from Canada. For years Trump plan would allow states to import drugs from Canada. Drug pricing reform plan will help the American people save a lot of money.
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