Questions regarding 'prognosis'-type claims
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Hi there,
Could you please provide me with some clarity around "prognosis"-type claims in a branded APS. For example, claims like, "People with diseaseA associated with mutationB have a worse prognosis" or "The five-year survival rate of disease A is 40%". (In the first example, the drug would be indicated for patients with diseaseA associated with mutationB).My questions are:
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Can you use these types of claims in a branded sense as long as they are clearly portrayed as "disease information"? And follow-up: would it depend on whether the product has OS data or not?
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These feel like they might fall under the burden of disease guidelines, is that correct (I'm thinking it could be "sequelae")? The BoD guidance says that sequelae for which the product has no data should not be emphasized - does that mean we can still mention them in an unemphasized manner?
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If you can use them in a branded sense, what kind of reference support do you need for them? If (2) is correct, would the references be the same as for burdens in section 3 of the BoD guidance?
Thank you so much for your help!
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