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Ann: FDA Strategy and Regulatory Update, page-47

  1. 25 Posts.
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    Incorrect. It is a misleading diagram. It says the acceptance is BY END OF DAY 15. Therefore, acceptance box finishes at day 15.

    The box of days 16-60 is the substantive review box. It even says "FDA conducts Substantive review (usually BY DAY 60).

    The more I read it, the more I know I am right. You guys are all to eager. We will be waiting ages.
 
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