Quite a while ago I asked the following question on this board (under subject trading):
Does anybody know how long it typically takes after the submission of answers to FDA questions untill the approval may be granted.
Ask the other way around: Does the FDA have a fixed time window, where the FDA needs to response after answers have been submitted. I do not mean the first time window of 90 days, where the FDA needs to response (in my understanding) in any form, e.g., generating a set of questions utilized for a final decission or provide the final "yes or no".

I know some knowledgable people from the medical sector are on this board and may fore sure have the right answers. Thanks!