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Thursday, July 09, 2020 10:38:48 AM
On June 30 Revive PR stated it had submitted FDA IND for phase 3 clinical trials:
TORONTO, June 30, 2020 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has submitted today its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“U.S. FDA”) for a Phase 3 confirmatory study for Bucillamine as a potential treatment in COVID-19. Once the U.S. FDA allows the IND to go into effect, Revive will initiate a randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 in Q3-2020.
Today's July 9th PR Revive states:
The aim of the Company is to file its 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”) this month and the Company also now intends to follow up with the submission of the complete CTA package for Health Canada around this Phase 3 study as part of the same multinational clinical strategy.
So did they submit the FDA IND or not? Conflicting statements.
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