Wow, do you think FDA approval would be any easier?
Look at CUV, I think its been circa 10 years and two different brand names and they are now just getting FDA approval, Hopefully anyway. Otherwise the 400% i am up will get smashed.
The goal posts are always changing,
https://www.fda.gov/medical-devices/...eveloped-tests
The good news is, PEB are one announcement away from being cashflow positive.