If the FDA asks for additional time then the review time is halted until a response is received from the FDA by Dean. After they receive the response from Dean the review process is then continued. Its not restarted just halted.
Good grief! I was feeling pretty good about an impending FDA approval, but after reading today's posts, I am in total despair. Apparently, no one has any idea that has the weight of authority as to when FDA approval can be expected. The suppositions run from "already due" to some vague date at or past the end of January. Am I missing something or am I just on calendar overload?