Accordian Expandable
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- Please note that all accordian headlines must reflect either a neutral message or the qualifying data/content must appear in the headline. The physician should not be required to click on the drop down menu to view the qualifying information.
A. We question "Fleximab demonstrated efficacy in PFS" as it requires immediate qualification with the respective data, statistical support and study parameters. We note the subhead "Discover how Fleximab can benefit your patients NSCLS" is unclear, unsubstantiated and absolute. We note the typo "NSCLS", please revise to "NSCLC" and elucidate all acronyms at first mention. (s2.1, s3.1, s2.6)
i)Please include the supporting data and stats for the body copy claim. We also note that the OS endpoint was not statistically significant, please include this statement in body copy to balance the PFS claims. (s3.1, s5.9, s4.1)
ii)The callout "keep an eye out for the rest of the flex campaign" is unclear. Please advise us what this is in reference to and provide the corresponding efile numbers to confirm the content has been PAAB reviewed. (s2.1)
B. We question "Fleximab provides a low 14.5% anemia risk" as it is overly selective and there are no stats to support this safety claim. We could consider this data presented in a non-emphasized manner along with other most common adverse events. As this is accordion copy we suggest revising to a neutral message such as "See Fleximab safety profile".
i) The accordion copy "well-established safety profile" requires immediate qualification. Please revise to a neutral message. Also, please remove the term "well" as it is not supported.
ii) We note that the incidence rates included in the table copy do not all align with the PM. Please ensure these are accurate.C. We question "...gives your patients flexible dosing options" as it is unclear how the dosing options are "flexible" and this claim requires immediate qualification. Please revise to reflect a neutral topic, such as "Fleximab dosing options". (s2.1 , s3.1)
i)The body copy "Fleximab is given orally once daily" is incomplete and not reflect of the PM. Please revise to include the dose and dose adjustment at 7 days.
ii)We question the callout, as it is unsubstantiated, overpromising, and absolute. The concept of "time" is not reflective of the outcomes assessed in the clinical trials and no support has been provided regarding "money". Please note that the hashtag and any social media promotions associated with this campaign must be submitted to PAAB for review. We also note that the term "FLEXtime" has unclear clinical implications, please remove. (3.1, s2.6, s2.1)
ii)Please revise the IV infusion section to reflect "over 30 minutes" to better reflect the PM. (s3.1)
iii)We question planning a trip, as it has quality of life implications. There does not appear to be data to support Fleximabs magnitude of effect on this clinical parameter. (s3.1) We also question "convenience" as this statement is not accepted for a product that is administered as an IV infusion. - Please note that all accordian headlines must reflect either a neutral message or the qualifying data/content must appear in the headline. The physician should not be required to click on the drop down menu to view the qualifying information.