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.
I've been keeping away from this board because it always seems to take so much time and attention when it sucks me in, and the posters were getting downright inane for awhile, but...
Yes! That FDA move, assuming it was instigated by Align, was great. I literally laughed out loud when I read it. I think Align's been certified (voluntarily) by the FDA for many years, and we expended plenty of effort and went through those audits to maintain it, so I'm glad it turned into an ace up the sleeve. I don't even know what kind of process OC goes through now... can they sell their product provisionally without FDA approval until they can get certified?
Glad to see the ITC thing went forward as expected, too.
Although I sold 1/3 of my shares since it's been hovering above 8 for awhile and anything can happen, I'm still long ALGN. I think the fact that both ALGN and OC are showing growth just shows how amazing ALGN can be when/if OC loses and ALGN owns the whole enchilada.
i.e. Align released him, plus even if they hadn't he could have competed with them anyway based on public interest regulation in CA. CA hates non-competes, that's what gave rise to Silicon Valley in the first place (witness Steve Jobs who left Apple to start Next Computer THE FOLLOWING DAY, or Cisco --> Juniper Networks, Oracle --> Salesforce.com, etc, etc, etc). Stories abound, this sort of thing is not uncommon.