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A sponsor must submit the iPSP before the date on which the sponsor submits the required assessments and not later than 60 calendar days after the date of the end-of-phase 2 meeting.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm360507.pdf The link I provided gives the complete rules and regulations. If you have further questions please feel free to respond.