ArradiCAN - Analysis -MKT Piece
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- Copy deck, page 1: We question the targeting of hematologists and colorectal cancer as misleading and off-indication. We also question lung cancer and respirologists as targeting.
- Copy deck, page 1: Please clarify whether these websites will be gated to HCPs. We have reviewed this piece with the understanding that it is intended for HCP use. We question the use of MedNEWS as it is ungated. (s4.4.3)
- Copy deck, page 1: The tagline has absolute efficacy claims and quality of life claims. Please remove or rephrase. (s2.6.1) We would suggest “ArradiCAN is a new option for your patients” or “You CAN give your patients another option”.
- Copy deck, page 1: Tagline: any claims supported by study data must be stated in the past tense.
- Copy deck, page 1: “Tagline to appear under product logo (ArradiCAN can…)” does not appear in the layout in the indicated place. It is also an incomplete and absolute claim. Please clarify.
- Copy deck, page 1: Claim must be in past tense as it comes from study results.
- Copy deck, page 1: Study data must be balanced with appropriate study design, please include the study design in a footnote alongside the date
- Copydeck, page 1: We question the callout “statistically significant improvement of..’ as misleading. There is no statistical significance associated with median PFS. Please rephrase this and remove it from a callout. Please also remove the 9.8 month, 6.5 month and 3.3 month call outs as this may mislead the viewer into seeing significance where there is none.
- Copydeck, page 1: Please move the Hazard ratio and P-value up so that it is directly beneath the PFS claim.
- 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.
- Copy deck, page 3: We question the use of the middle level fairbalance, as there are efficacy and safety claims, the highest level is required. Furthermore, please use the correct terminology when referring to the warnings and precautions at least once at the beginning “immune-mediated…”
- Copy deck, page 3: Please include the website that the QR code links out to
- Copy deck, page 3: You cannot link out to unbranded content in a branded context. If you would like to link out to the government website or PAABceutical website it will need to be directly to the home page. Please specify if any content on the PAABceutical website is unbranded.
- Copy deck, page 3: Please remove the link to the clinical trials website. We question the promotion of a clinical study that is still in progress and for off label use.
- Copy deck, page 3: We question the prompt to contact medinfo for more data on the endpoints discussed. Please provide this data for our review.
- Layout: Sizing of images and font should be revised. Images on the left are too large, the indication is too small relative to the claim.
- Layout: We question the use of before and after images, especially the time difference between images which implies longevity, efficacy, and improved quality of life which is misleading and unsubstantiated. The use of colours and family/friends creates a misleading separation too. (s2.6.1)
- Layout: Please increase the font size of the indication relative to the first claim.
- Layout: Please use the correct graph. This one is product vs. placebo, not product vs. chemotherapy. Or provide a reference and include it in the copy deck.
- Layout: Please remove the arrow from the second graph. This overemphasizes the relative risk and alludes to a direction which may be misleading. Please consider an alternative shape.
- Layout: Please reduce the font size of the MOA and safety claim so that they are within 75% of the fair balance. Also please increase fair balance so that it is within 75% of the largest claim copy.
- Layout: Please provide a reference to support the claim that this product is new and include it in the copy deck.
- Layout: Upon renewal of this eFile, you will be required to remove “New”.
- Layout: Please decrease the size and move down of the PSP design as it is overemphasized. Its presence amongst product information is misleading. Claims about the program cannot be applied to the product.
- Layout: Please ensure that MOA and safety/efficacy information are separate.