RE:RE:RE:RE:wateroperator: You are correct that they haven't applied...yet. Look at a company like MIR that applied in April, and still hasn't received approval 3 months later.
Sona is going about this the right way. They got validation from a top US lab that works with the FDA on a regular basis. They are also doing field studies to backup their validation from MRI Global.
They also have Sandy Morrison and Fiona Marshall on their team. Sandy was involved in obtaining regulatory approval for the first rapid assay HIV test from both HC and FDA. He has over 30 years in the medical device field and offers extensive experience in this department.
Fiona Marshall was involved in development and manufacturing of various lateral flow tests, including tests for class 3 deadly pathogens that served US military contracts. She also oversaw the rapid test development in 2013 for the Ebola outbreak.
These advisors aren't here to play games. Sona is surrounded by all the right people and they absolutely are the real deal.
Once they do apply, the FDA won't hesitate to approve a company with such an impressive resume, that made sure all their ducks were in a row BEFORE applying.
The reason companies like MIR wait so long, is because they didn't take these steps. Sona is doing everything right.