any mention may mean delays by FDA could mean "penalty delay"
in latin they say "Quad Est Demonstrandum"
BIEL's application is I believe technically valid and will therefore be cleared for sale but it is pushing the limits of the process.
In the mean time though thousands of people around the globe are benefiting from the device and living better lives. I invested (and am making a profit on my investment) in a company that does that - improves peoples lives. I expect to hear how well they are doing in the coming weeks. If the US FDA happens to process the application as well I know I will have paid off my debts for sure.