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The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions.
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The lung function improvements on top of current bronchodilation clearly indicates that roflumilast improves lung function over and above what can be achieved with other COPD treatments alone.
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The finding mirrors earlier research that found that being slightly overweight may have no impact on life expectancy, but being severely overweight can shorten life spans dramatically, the newspaper said.
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