I'm not sure. The "clock has been stopped" for a
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Posted On: 09/01/2020 2:05:19 AM
I'm not sure. The "clock has been stopped" for a while now. If you go to:
https://www.fda.gov/media/78941/download
Scroll down to Appendix A (page 52 of 90) and I think we'd be back at Step 12.
You may be correct.....
If the FDA "starts the clock again" from Day 60....then announcement of "Communicate “Program” Review Timeline to
Applicant" would be at Day 74....Hmmmm...that "14 days" thing just popped up....
https://www.fda.gov/media/78941/download
Scroll down to Appendix A (page 52 of 90) and I think we'd be back at Step 12.
You may be correct.....
If the FDA "starts the clock again" from Day 60....then announcement of "Communicate “Program” Review Timeline to
Applicant" would be at Day 74....Hmmmm...that "14 days" thing just popped up....
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