$TBRIF Therma Bright Provides Update on FDA EUA Re
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Posted On: 09/12/2022 9:11:15 AM
$TBRIF Therma Bright Provides Update on FDA EUA Review Process
https://www.newsfilecorp.com/release/136759/T...ew-Process
Toronto, Ontario--(Newsfile Corp. - September 12, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"
, developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, provides an update on it AcuVid™ COVID-19 Rapid Antigen Saliva Test's Emergency Use Authorization application with the U.S. Food and Drug Administration.
The Company has received communication from the FDA which states they have completed an initial review of our AcuVid™ EUA application and have asked for additional details and questions to be addressed on our rapid saliva test solution. The Therma Bright team is working closely with its strategic partners and suppliers to comprehensively and clearly respond to the FDAs questions. Once this effort is complete, the Company will resubmit its EUA application with all the additional documentation and tests requested by FDA reviewers, including details around transport and storage of RT PCR samples, additional data on external controls used, and further validation on AcuVid's ability to detect the Omicron variant post March 1, 2022, when the variant achieved 100% overall prevalence in the U.S. State of California variant tracker (https://covid19.ca.gov/variants/), where the U.S. clinical study was performed, shows Omicron was 90.0% of all new cases on December 29, 2021 and 99.8% on February 1, 2022.
"We and our strategic partners are confident in the performance of our innovative AcuVid™ COVID-19 Rapid Antigen Saliva Test and will continue to work with FDA officials in answering their questions in order to bring our solution to the U.S. marketplace, including providing the specific data and details as needed for authorization," shared Rob Fia, CEO of Therma Bright. "In tandem, we'll continue to pursue sales where authorized, as we navigate regulatory authorization processes from around the globe."
The FDA does not provide timelines on how long approvals will take. The Company will update the market as required.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
https://www.newsfilecorp.com/release/136759/T...ew-Process
Toronto, Ontario--(Newsfile Corp. - September 12, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"
, developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, provides an update on it AcuVid™ COVID-19 Rapid Antigen Saliva Test's Emergency Use Authorization application with the U.S. Food and Drug Administration. The Company has received communication from the FDA which states they have completed an initial review of our AcuVid™ EUA application and have asked for additional details and questions to be addressed on our rapid saliva test solution. The Therma Bright team is working closely with its strategic partners and suppliers to comprehensively and clearly respond to the FDAs questions. Once this effort is complete, the Company will resubmit its EUA application with all the additional documentation and tests requested by FDA reviewers, including details around transport and storage of RT PCR samples, additional data on external controls used, and further validation on AcuVid's ability to detect the Omicron variant post March 1, 2022, when the variant achieved 100% overall prevalence in the U.S. State of California variant tracker (https://covid19.ca.gov/variants/), where the U.S. clinical study was performed, shows Omicron was 90.0% of all new cases on December 29, 2021 and 99.8% on February 1, 2022.
"We and our strategic partners are confident in the performance of our innovative AcuVid™ COVID-19 Rapid Antigen Saliva Test and will continue to work with FDA officials in answering their questions in order to bring our solution to the U.S. marketplace, including providing the specific data and details as needed for authorization," shared Rob Fia, CEO of Therma Bright. "In tandem, we'll continue to pursue sales where authorized, as we navigate regulatory authorization processes from around the globe."
The FDA does not provide timelines on how long approvals will take. The Company will update the market as required.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
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