Acronyms/layout
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For clarity, please ensure that all acronyms are elucidated at first mention. (s2.1)
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Layout: We note the layout and copy differ. The layout has been reviewed for position/creative content, not copy correctness.
i)please ensure that the brand name, non-proprietary name and federal drug schedule appear in juxtaposition at least once in the APS. (s2.2)
ii) The 2 patient images have implications related to quality of life/functionality that are unsubstantiated. This clinical claim requires the inclusion of data quantifying the magnitude of effect the Fleximab has on QOL/functionality. Please remove. (s3.1)
iii)We question the emphasis on FLEX throughout the product logo and claims as it implies product flexibility which is unsubstantiated. It also creates a link between clinical and non-clinical concepts throughout which are not acceptable. Please remove cap visual treatment. -
General Comment: We question the calendar images as they dosing schedules (oral dosing in particular) are not aligned with the recommended dosing in the PM. Also, please remove all mention of other activities in the calendar as they allude to functionality and QOL.
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