Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) has said it continues to communicate with the US Food & Drug Administration (FDA) regarding its application for Emergency Use Authorisation (EUA) for its AcuVid COVID-19 rapid antigen saliva test.
The medical diagnostics and device technology company also said Health Canada's application for approval under the interim order is moving along expeditiously with consistent feedback and answers between Therma and Health Canada's technical and medical reviewers.
"We thank our shareholders for their continued patience and support. The FDA EUA review process is a rigorous and thorough process, as are all regulatory reviews, and therefore patience is required," Rob Fia, CEO of Therma Bright said in a statement.
The company also said it has sought and utilized advice from Ridge Global and its FDA regulatory consultants to determine how best to accelerate the review of the AcuVid EUA application.
READ: Therma Bright submits Health Canada application for its AcuVid COVID-19 rapid antigen saliva test for point-of-care use
In addition to responding to the FDA's initial review and request for additional information, the company said it expects to receive further feedback from the FDA once they review the submitted responses.
Therma Bright also announced that it has fielded several potential sales inquiries for AcuVid and is currently discussing an order utilizing its self-certification CE mark for sales into Eastern Europe and other countries where the self-certification CE mark is accepted.
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges.
Contact the author at jon.hopkins@proactiveinvestors.com