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mapman1010

11/29/17 5:48 PM

#132327 RE: falconer66a #132326

Thank You
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Investor2014

11/29/17 6:06 PM

#132328 RE: falconer66a #132326

Why would A2-73 not simply fall under this existing 2014 (draft) guidance and one of the expedite approval paths defined in it?

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

What else specifically might we be waiting for?