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flipper44

11/28/24 12:33 PM

#734591 RE: Doc logic #734587

Take away the initial 80 to 90 day delay in order to enter the review cue where priority was based on entry date, and we simply are not that delayed. We are currently at 219 to 229 days with two indications if you subtract the time above.

Upon entering the cue, our only true difference from many other, but not all, submissions, is that we are applying for two indications.

The averages you speak of for new active substances are not cumulative, they are monthly. So it way easy to pop from 208 days to 298 days average, and it’s just as easy to pop downward again, particularly given the elimination of all, yes all prior year backlogs.