Claims & Support/References for Claims
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30 - Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?
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17 - If a reprint carrier is being produced, can the content be based on the paper even if some of the points to be made are not part of the product monograph? For example, if data pertaining to subgroup and multivariate analyses were not included in the product monograph but are discussed in the article, can they, i.e., subgroup and multivariate analysis, be part of the text highlighted on the reprint carrier?
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12 - ACME Pharma ha 20% of the share in Rx's in its class and has been gained about 5% share over the previous year. NEWGUY Pharma has a 2% share, up from 1% the previous year. Can NEWGUY claim "fastest-growing" product within its class by virtue of a 100% growth? Even though ACME experienced only a 20%, twenty percent of a million is a lot more 100% of 20,000. How would PAAB rule NEWGUY's claim of "fastest-growing" or "largest annual growth"?
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