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Re: Emannow post# 3110

Wednesday, 12/28/2022 12:37:42 PM

Wednesday, December 28, 2022 12:37:42 PM

Post# of 9090

I believe the FDA has approved the wording “Daxxify last on average 6 months and up to 9 months for some.”



The FDA Statistical Review makes explicit note of the fact that Revance initially submitted a moderately large set of secondary endpoints, but only two remained after FDA critique (the two in the label). Essentially the difference comes down to 'or' vs 'and'. FDA approved one in statistical review, Revance is using the other. Note that the published papers show both.
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