RE:Why it takes sooo long for approval? Nirajan you may be part right. The Brazilian studies while bigger in sizes than many other approved tests occurred outside of Canada and the US. The FDA imin particular is nitpicky about these things hence it asked for an added study in US which was completed and sent in at the end of March. Also the added study was asked for because the rules of the game shifted last September requiring testing against Omicron if you remember.
hindsight is always 20/20 and perhaps Rob may have done this differently if he had known about the extended delays but that is just me speculating as I don't know the particulars (neither does anyone else on this board).
going forward we are where we are and I'm sure between Rob, Ridge Global and external consultants are doing the best they can with the beast that is the FDA. I agree with others we may get HC approval first which could only improve our chances of speeding things up with FDA. If in the unlikely case there is an anti Canadian bias as some have speculated so what? I'm happy with only HC approval as the size of this market is big enough to result in a good payday
good luck to you