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  4. Discussing 'unmet needs' in a branded piece
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Discussing 'unmet needs' in a branded piece

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  • K Offline
    K Offline
    kshulist
    wrote last edited by
    #1

    Hi there,
    I gather from Question 99 (https://forum.paab.ca/topic/247/99-does-paab-have-specific-rules-regarding-pre-noc-communications?utm_source=chatgpt.com) that you may discuss unmet needs in a unbranded sense as long as you are not being disparaging to other treatments nor pointing to a specific treatment.

    My first question is whether you can discuss unmet needs in a branded sense? My assumption would be (following the logic of Question 99) that you cannot discuss unmet needs in a branded sense because the branding would inherently point to a specific treatment (even if you are careful with the copy). Is that correct?

    My next question is could you discuss unmet needs in a branded sense if the drug is the first ever (and only) treatment for a condition? In this case, there was a clear unmet need (there were no treatments), now there is a treatment option, and there are no other treatments to disparage or 'point away from'.

    Thanks so much for your help!

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