Revive Therapeutics Ltd (RVVTF)

[ReikoBlack]

http://www.globenewswire.com/news-release/2020/06/09/2045848/0/en/Revive-Therapeutics-Provides-Update-on-Discussions-with-Health-Canada-in-Pre-CTA-Meeting.html?ev=1

June 09, 2020 12:06 ET
Revive Therapeutics Provides Update on Discussions with Health Canada in Pre-CTA Meeting

TORONTO, June 09, 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 that the Company met with Health Canada in a Pre-Clinical Trial Application (“Pre-CTA”) meeting to evaluate the potential of a clinical study of Bucillamine in the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection in Canada.

The Pre-CTA meeting provided an opportunity for Revive to discuss Bucillamine’s scientific rationale of its potential use in the treatment of COVID-19 infections, Chemistry, Manufacturing and Controls, non-clinical and clinical safety information, and clinical trial design. Health Canada provided valuable guidance on the proposed clinical study design and information required for the submission of a complete CTA package. 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.

“We were pleased with our discussions with Health Canada at the pre-CTA meeting which provided us with valuable guidance on the clinical study design and information that is required for the submission of the complete CTA package,” said Michael Frank, Revive’s Chief Executive Officer. “We are focused on advancing Bucillamine as a potential treatment for COVID-19, and the submission of our FDA IND application for our Phase 3 clinical study will form the foundation for our multinational clinical plans including Canada."

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (or SARS2 Coronavirus) at this time.

a link for this then?

Quote:In June Revive had the Pre-CTA meeting, but didn't officially apply for the CTA yet.



not really familiar with Health Canada