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Re: eicoman post# 27135

Friday, 03/17/2017 3:42:32 PM

Friday, March 17, 2017 3:42:32 PM

Post# of 30352
Isn't it true that the FDA must act on the resubmission within 6 months only because the focus is on curing the deficiencies?

If Apricus has an improved formulation to present in the resubmission package, is the FDA still obligated to act within 6 months?

I think we can agree that the only NDA submission to the FDA so far was many years ago -- so any new data supporting a 7 day shelf life has not yet been submitted.

If they submit that data along with the data curing the deficiencies, does the 6 month evaluation deadline still apply?
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