The response package to the US FDA has been submitted as directed by the Agency,
through a request for review pathway. The request for review pathway does not have
strict Prescription Drug User Fee Act (PDUFA) Agency response timelines, although
feedback is typically received within three months.
Looks like they are not bound by usual timelines @bobsee. This makes FDA response very unpredictable.
Ann: Type D Response Submitted and Received by the US FDA, page-18
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