ArradiCAN - Page 2 - review
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Copydeck, page 2: We question “24%” reduction in death as incorrect. Please revise to 40%.
Copydeck, page 2: Please include the hazard ratio and the p-value so that it is direcly below the claim.
Copydeck, page 2: We question the representation of the relative data “30% vs. 40%” without the absolute number of pagtients in each group. Please include the number of patients in both treatment groups.
Copydeck, page 2: We question the addition of “ median in months not reached for either,” please remove or include all data available.
Copydeck, page 2: We find the callout “ total: 254 of patients treated,” to be misleading and unbalaned. Please include the number of study participants in the chemotherapy group.
Copydeck page 2: We question the patient support group general copy and layout as misleading. Please include more information about the patient support group, include the disease state that is associated with it. Alone, the years of experience, number of patients may be misinterpreted as data from AradiCAN.
Copydeck, page 2: We question the claim “ One trusted program for seamless patient support” as unsubstantiated.
Copydeck, page 2:Please provide a med reg letter to substantiate the claims of years of experience and number of patients enrolled.Copy deck, page 2: We question the hanging comparison “low incidence of immune mediated pneumonitis,” as being use in a promotional context and without an attitude of caution. Furthermore, should you wish to use this data, please include the data of ALL grades of pneumonitis.
Copy deck, page 2: Please include a disclaimer that the MOA has no known clinical significance.
Copy deck, page 2: Please specify the content of the site “ArradiCAN,” is this gated? Will this lead to the HCP site? Please include eFile number of website.