Is there anyone else that sees this as a positive thing for the company? They've lived under the cloud of potential FDA regulation for a while, and I'm a bit surprised that it took this long for the FDA to step in.
Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company.
Now that the FDA has played their hand, I'm very curious to know how the company will respond.
Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company.
Now that the FDA has played their hand, I'm very curious to know how the company will respond.