If you want my take on how this repackaging affects the FDA's mindsight for its review clock, I honestly don't think the package that Dean sent to the FDA would reset any clock, and here's why. The FDA did not request it. It sounds to me like Dean sensed that the FDA Review Team was confused about where things fit into the overall application, so Dean, on his own initiative, resent the entire package with a road map for the reviewers to follow. Since the FDA did not request that package, there would be no reason for it to cause the clock to reset.
Here's my take in detail:
The complete package was sent to the FDA on April 5 and received April 9. A few weeks pass before the FDA even looked at it at all. When they picked it up, they noted a couple of language changes in a couple of documents they wanted and noted that they had trouble viewing some images in the format in which they were sent (because of software compatibility issues). They notified Dean by phone and email of these three minor issues (this was the 3 requests back in late April). Dean promptly made the language changes in the documents requested by the FDA (say for example, a word on page 12 of one document and another word on page 25 of another document) and assembled the specific images requested by the FDA in a format they will be able to view on their computers. He then sent to the FDA only the pages on which he made the changes they requested and only the images the FDA said they couldn't view. All of this sits on somebody's desk at the FDA for a while until they get around to looking at again. When they pick it up again, they are confused about it how those specific pages and those specific images fit into the overall application (because they are stand alone pages at that point). After some back and forth about where they fit in, Dean decides because of the FDA's confusion, on his own initiative and for the convenience of the review team, to just send the entire package again in an easy to view format with an index on the front explaining where specifically in the pacakge the FDA can find the answer to their previous questions. There were no changes, nothing re-written, or modified, just converting the file type. This, I'm sure, did not take much time at all (not even a day). It was just a repackaging of the original submission with the 3 changes requested by the FDA and a road map where the FDA could find those changes and answers to their other questions.
With all that in hand now, the FDA can finish the job that they were trying to finish in early July (i.e., by July 8th like we all thought). I really don't see this taking much more time at this point, and since the package Dean sent was sent on Dean's own initiative, there is no reason for it to restart any review clock.
Just my humble opinion.
