Right, there’s no reason to delay if everything’s in order.
Begging the question: Why?
I really do believe this delay or soon to be delay is connected with receiving a response back from the FDA on Fast Track, just because that would be a force multiplier along with positive TLD; and therefore, worth waiting on. The gov’t is just plain slow, even when there’s a statutory deadline. And FDA may still have a week or more before that deadline is reached.
Just my opinion.