The FDA had difficulties trying to understand where and what the corrections were that Dean had made. Therefore, to quickly prompt them through these changes to manuals, documents, etc, Dean sent in the package again but this time cross-referencing to the changes making it easier and faster for them to sort through. Remember these packages are 6-8 inches thick so what Dean did is is smart because it creates shortcuts straight to the changes in the submission. We can expect $5+ easy on approval any day now.
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