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Re: drugrunner post# 703287

Tuesday, 07/02/2024 12:45:18 PM

Tuesday, July 02, 2024 12:45:18 PM

Post# of 707605
Great points plus additional feedback
Will we get an RFI .. most likely ?
How long to resolve an RFI .

I have also worked with multiple Regulatory Agencies in the past.
Prior to submitting to the Regulatory Agencies, we created multiple teams to address all of the key factors. In most of the cases, the information was more than enough for the Regulatory Agency, and the Regulatory Agency did not require an RFI.

Hope NWBOs team did the same?
Definitely agree that if an RFI is requested, the timeline to resolve should be short per your estimations, IMPO.
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