Volume starts to increase, which is in my opinion not a bad sign - especially with pps increase. 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!