US based company with better results launching world wide, page-42

did you really not get my point or you playing with old person ?

think this way, if hypothetically RHY starts selling their kit using CLIA path without FDA approval then they will not be able to sell it at or above even the price of FDA approved test (on assumption that why would someone pays high fees if it isn't FDA approved) and they have to put their price in line with others using CLIA path which in my previous post i mentioned could be anywhere between $15 USD to $90 USD (on assumption that they need to be competitive) ... now, once you start selling your product this low price then do you think after FDA approval for some reason FDA will approve higher reimbursement ? there is no logic to it and FDA isn' dumb in my opinion.

regarding, other jurisdiction is there any timeline and cost guidance provided by company on how long will it take and again whether they planning to go through reimbursement route or private route? in my opinion company should only concentrate on developed world such as US, OZ and EU to get the reimbursement approved and get the cashflow going and should not attempt to sell cheap anything without reimbursement now downside to that is tht someone else might get their product in market first and you probably lose first mover benefit but that is what the company needs to review & report on how solid is their data that they collected so far in order to get FDA approval.... ? do they need new trial or current data is good enough and it is simply matter of re-submitting it to FDA ?

so as a shareholder first thing you need to ask CEO next time if the talk on CLIA is what would be the device cost difference if it is sold after FDA reimbursement approval vs CLIA ? do they need new trial for FDA or current data is good enough ?

you didn't answer so let me ask again, do you know current cost (reimbursement) of FDA approved test ?