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Re: None

Friday, 03/31/2017 7:51:57 AM

Friday, March 31, 2017 7:51:57 AM

Post# of 106839
Great read from the FDA. The fact that the PR states they are working with the FDA could mean this baby is a done deal.

https://www.fda.gov/RegulatoryInformation/Guidances/ucm341918.htm

I like the word complete here:

b. Timing of Substantive Interaction

Substantive Interaction should occur following acceptance of the submission and after FDA has performed a complete review of the submission and within:

60 days of the receipt date of a complete submission