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JTORENCE

09/19/18 12:28 PM

#241777 RE: Amatuer17 #241766

IPIX doesn't have the $$$$ to wait that long.eom
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PlentyParanoid

09/19/18 12:39 PM

#241782 RE: Amatuer17 #241766

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FDA draft guidance to formal meetings can be found here: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.