What factors might you use to argue in favor of FDA approval?

A Phase III 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?