Getting FDA to Phase 3 trial is a substantial plateau "The FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the Covid-19 Phase 3 trial and, therefore, the company did not have to perform any Phase 1 or Phase 2 clinical studies," the company reported.
"Because of our history with Bucillamine, and that Bucillamine has been around 30 years and it's been effective in South Korea and Japan treating rheumatoid arthritis, and because of the data, we were asked to provide an IND to go directly to a Phase 3 trial—a much bigger trial," Frank said.
"FDA's support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of Covid-19,' noted Frank. "Entering into a Phase 3 study is a major milestone for the company, and we are excited to unlock the full potential of Bucillamine not only for this virus but also for other infectious diseases that we will investigate in the future."
Revive has also stated that it intends to conduct a clinical study of Bucillamine in Covid-19 patients in Canada and today announced that it has submitted a Pre-Clinical Trial Application (Pre-CTA) to Health Canada and will have its Pre-CTA meeting with Health Canada this week.
"Unlike many micro caps in Canada and in the United States, getting to Phase 3 trial is a substantial plateau, and that's what sets us apart," Frank added.
https://stockhouse.com/opinion/independent-reports/2020/06/04/micro-cap-pharma-moving-ahead-with-plans-for-phase-3-us-trial-repurposed-drug