I agree, this has the potential to be huge and may be a tack Zia did not see coming. I have posted some historical info about FDA clearence on the board in the distant past, but its worth repeating for the current readers.
First, there has been a general misconception for all of these years that Invisaligners were FDA approved from day one. They were not. They were FDA cleared, which is a totally different catagory. It basically means that Align got a letter from the FDA stating that their concept was exempt from the rigid FDA approval process. How did that happen? Well, Kelsey Wirth's father is a former US Senator. Using his connections, a former FDA official was appointed to an early Align board of directors to help the company get that very important letter (we are talking pre-IPO days here). How this classification change might affect OC is uncertain, but certainly should make for some interesting moments in Pakistan. The chess match continues.