$TBRIF Therma Bright Provides Progress Update on F
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Posted On: 08/04/2022 8:21:09 AM
$TBRIF Therma Bright Provides Progress Update on FDA EUA & Health Canada Interim Order Applications for Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
https://www.newsfilecorp.com/release/132813
Toronto, Ontario--(Newsfile Corp. - August 4, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"
, developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide the following update for Its AcuVid™ COVID-19 Rapid Antigen Saliva Test.
Therma continues to communicate with the FDA regarding its EUA application for its AcuVid™ COVID-19 Rapid Antigen Saliva Test. As well, Therma has sought and utilized advice from Ridge Global and our FDA regulatory consultants to determine how best to accelerate the review of the AcuVid™ EUA application.
In addition to responding to the FDA's initial review and request for additional information, the Company expects to receive further feedback from the FDA once they review the submitted responses.
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", commented Rob Fia, CEO of Therma Bright.
Therma is also pleased to announce that it has fielded several potential sales inquiries for the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Therma 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.
https://www.newsfilecorp.com/release/132813
Toronto, Ontario--(Newsfile Corp. - August 4, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"
, developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide the following update for Its AcuVid™ COVID-19 Rapid Antigen Saliva Test. Therma continues to communicate with the FDA regarding its EUA application for its AcuVid™ COVID-19 Rapid Antigen Saliva Test. As well, Therma has sought and utilized advice from Ridge Global and our FDA regulatory consultants to determine how best to accelerate the review of the AcuVid™ EUA application.
In addition to responding to the FDA's initial review and request for additional information, the Company expects to receive further feedback from the FDA once they review the submitted responses.
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", commented Rob Fia, CEO of Therma Bright.
Therma is also pleased to announce that it has fielded several potential sales inquiries for the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Therma 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.
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