FDA guidance is formally implemented?? If this is the reason, "Probably" 2 years from today, not "Probably" 2nd Quarter this year. Don't expect FDA acting so fast as you expect.
I don't believe this is the reason for quiet period.
I agree that it has been a delay, and not sure given FDA journal article it still is practically, but we will have to see. The reality is the guidance was technically not for immediate implementation. But that journal article was unexpected and not sure if a journal would do it. It has been a concern and I think it was more than enough reason, at least up to this point. It might’ve that that plus already implemented rules in the UK might be adequate. Though yours is the more rigorous and reasonable position. Mine is close to wishful thinking.