MedMira Inc V.MIR

Question

[Red~One]

From 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 ?

[Nathaniel13]

The application was made prior to Jan 15th as confirmed my MM. I don't know exactly what date. They have not relieved the acknowledgment letter from FDA, which provides them with the right to sell under the guidelines. Don't worry--the FDA has been very public about their efforts to assess the impact of the new variants on approved products and haven't issued EUAs for about 3 weeks

[Rossaporino]

Thank you sir. For all the information  I feel so good to see and read all these information  I believe in small business opportunities and Medmira will   be remarkable company  as Mr chan said the goal to be billion dollars company and  a with all experience they have , they are in in business for decades  . The test was developed and validated using

[Red~One]

Thanks for sharing this N....so did they confirm the EUA submission for the Plus test at the meeting Friday or anywhere else. I don't see it mentioned in any NR's Thanks R