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Posted On: 12/18/2018 6:15:05 AM
Post# of 72441
In addition to the meeting minutes, any additional FDA-conducted modeling and simulation materials derived from sponsor-provided data will be given to the sponsor following the meeting.
https://www.fda.gov/downloads/Drugs/GuidanceC...079690.pdf
Just like any business meeting. Likely very shortly after it's completed. Hours to the next day imo.
https://www.fda.gov/downloads/Drugs/GuidanceC...079690.pdf
Just like any business meeting. Likely very shortly after it's completed. Hours to the next day imo.
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