Trial of a new medication: what factors might you use to argue in favor of FDA approval? how would you argue against FDA approval?

Description

Trial of a new medication has been completed. Data analysis reveals that the new medication is ‘statistically’ significant in giving a superior result from the standard treatment. Then (as in the hypothetical case presented by Turner) the new medication is shown to have a small practical or clinical value. What factors might you use to argue in favor of FDA approval? How would you argue against FDA approval?