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Re: alternatepatel post# 29674

Monday, 06/23/2014 10:25:42 AM

Monday, June 23, 2014 10:25:42 AM

Post# of 426504
Exactly: "They have an opportunity to ask us questions along the way. There's typically an opportunity for a face -- one face-to-face meeting and follow-up questions. And then there'll be a period after those occur that the FDA typically responds in roughly 30 days"

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Q1 CC: "And then we'll probably end up meeting with him 30 days after we submit. And then after that, he should get back to us within another 30 days."

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf
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