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Re: Montanore post# 1958

Tuesday, 05/11/2021 2:29:19 AM

Tuesday, May 11, 2021 2:29:19 AM

Post# of 13742
There is a 30-day period If FDA does not respond, it is approved, In this case QNTA would be May 12 or 13. Until now we still haven't heard a rejected notice from the company, therefore I assume 99% it get the approval.

"An IND application may go into effect: 30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or

- on earlier notification by FDA that the clinical investigations in the IND may begin. "


https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

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