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Amigo Mike

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Amigo Mike

Re: Aloha922 post# 22276

Monday, 01/23/2017 9:54:51 AM

Monday, January 23, 2017 9:54:51 AM

Post# of 38634
Aloha,

The FDA procedures are an interesting read regarding the NDA process. They can be found here.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM218757.htm

The FDA would have had its internal "filing" meeting to decide on the application by day 30 for priority review and day 45 for standard review. (Section 3.2.3). Clears up the process and some misconceptions.

Amigo Mike
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