Looks likely they may have run out of time over Christmas and New Year to get through the 17,000 pages of info. There's no provision for the FDA to gain additional time other than through a clinical hold.
Ordinarily, if the FDA has questions / clarifications, you'd hear about this during the assessment period.
Perplexing to say the least!
Cheers
Densy
Ann: Neurizon updates on NUZ-001 IND Application, page-3
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