Ann: Update on US FDA De Novo Classification Request, page-84

Hey TK, you can't release the worst double whammy this company has ever had without some type of explanation.
How can the only resp app in the world be called as being unsafe.
We are in the world's largest resp pandemic with a bunch of clowns running the rap show.
Put it in the app store [like Candy crush} with a few disclaimers and let the general population download it at home at $5 a pop.
Get some F----- revenue!!
Then the Americans can have access to the app like the rest of the world.
At very least PLEASE EXPLAIN!!!!!