QuestionFrom May 27,2020 NR; "In early May, MedMira has submitted an application to obtain FDA Emergency Use Authorization (EUA), however, while awaiting the approval, REVEALCOVID-19™ Total Antibody Test can be distributed in the U.S. according to Section IV.D of the Policy for Coronavirus Disease-2019 Test."
From Dec 30/2020 NR:"To ensure the EUA application for the enhanced product, REVEALCOVID-19™ PLUS Total Antibody Test, satisfies the EUA guidelines, MedMira is required to withdraw the current application for the REVEALCOVID-19 TM from the EUA notification list to obtain a new EUA listing for the REVEALCOVID-19 TM PLUS Total Antibody Test. At the same time, MedMira will submit a new interim order application to seek Health Canada authorization of REVEALCOVID-19 TM PLUS Total Antibody Test."
From January 29/2021 News Release:"Regulatory update as well as the latest product development strategy will be publicly announced soon."
EUA Application implied but not stated so do we now have the right to distrube in the USA based on Section IV.D of the Policy for Coronavirus Disease ?