- Therma Bright (THRM) updates its FDA EUA application process for AcuVid COVID-19 Rapid Antigen Saliva Test
- Therma Bright has been most recently working on follow-up answers and reformatted data which has now been submitted
- The hope is that this step in clarification and refinement will bring Therma Bright closer to a successful FDA response for Emergency Use Authorization (EUA)
- Back in February of this year, the final U.S. clinical performance study data submitted exceeded the FDA EUA minimum requirements
- Upon looking over the data, Therma Bright removed irrelevant U.S. Clinical test data which was submitted in the original March 29 application
- Therma Bright Inc. (THRM) is up 6.90 per cent, trading at C$0.16 at 1:27 pm ET
Therma Bright (THRM) has clarified questions on the EUA application to better meet the application requirements.
The developer of the smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, Therma Bright, has recently reworked follow-up answers and reformatted data.
The hope is that this step in clarification and refinement will bring Therma Bright closer to a successful FDA response for Emergency Use Authorization (EUA).
On March 29, 2022, Therma Bright submitted its FDA EUA application for Point of Care Use.
The application submission included a great deal of detail on the AcuVid COVID-19 Rapid Antigen Saliva Test, including over 490 combined test results from the U.S. and Brazilian clinical performance studies.
In February of this year, the final U.S. clinical performance study data submitted exceeded the FDA EUA minimum requirements.
However, the company spent the most recent months working with FDA officials.
Upon looking over the data, Therma Bright removed irrelevant U.S. Clinical test data submitted in the original March 29 application.
Upon re-calculating the clinical study results, the Therma Bright team discovered that the U.S. clinical performance study performed better.
Reworking its answer may lead to a more positive outcome, said Rob Fia, CEO of Therma Bright. “Our AcuVid COVID-19 Rapid Antigen Saliva Test performance clearly demonstrates its ability to detect this horrible COVID-19 virus quickly and effectively”.
Staying positive through facts seems to be Fia’s motto. “We anticipate a successful conclusion to our Emergency Use Authorization application. As reference in our recent Health Canada announcement, we plan to use the data and FDA EUA application answers to apply for and secure other regulatory approvals around the world.”
Therma Bright is a developer of the smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test.
Seen as a progressive medical diagnostic, the device technology company focused on providing consumers and medical professionals with solutions to address significant medical and healthcare challenges.
Therma Bright Inc. (THRM) is up 6.90 per cent, trading at C$0.16 at 1:27 pm ET.
