RE:Lets just sayAs per the news release:
In addition, the company has received the final seven outstanding RT-PCR test results from the Brazilian study to match against its AcuVid saliva test, exceeding the minimum requirements of 30 positive/30 negative results for its Food and Drug Administration emergency-use authorization (EUA) submission. The study results will also be used for Anvisa (Brazil) and Invima (Colombia) submissions, as well as to further support the CE approval received in April, 2021.
We are excited that our Brazilian clinical study has now met the minimum FDA-EUA requirements for our submission to secure serial testing approval," expressed Rob Fia