Agree on some of the perspective but I have to believe that they are further along and that COVID had been a factor. Remember, not only do they have to get approval for the product use, but they also have to get FDA approval to manufacture it; ie equipment and facility. Because they didn’t have a facility in the US, they had to have one set-up. PMA requires this for approval!
I think you are out of your mind if you think this will be minimum 180 days. Yes, I thought it would have been done sooner. Lesson learned. However, you are going completely overboard the other way.
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