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Re: Amatuer17 post# 241766

Wednesday, 09/19/2018 12:39:24 PM

Wednesday, September 19, 2018 12:39:24 PM

Post# of 403047
It is a two stage process. FDA will respond to a request for end of phase meeting within 14 days. If the request is granted the response will provide the date for the meeting to be held within 70 days (end phase meeting). All times are counted from the date FDA received the request.

FDA draft guidance to formal meetings can be found here:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf

The above makes me think the next (tentative) PR will be about scheduled end of phase 2 meeting.

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