Hemophilia therapy in the United States

5 pages paper about regulatory process for biological, I have attached the general question and how to write the paper, but the specific question ( Scenario) is this:

You are a primary reviewer in CBER at the U.S FDA. A biotech company is submitting an application to license a viral-vector hemophilia therapy. They are using an adeno-associated virus vector expressing the factor VIII gene. The vector transduces cells and persists as episomes within the cell. Clinical trials have been performed to demonstrate and efficacy of the approach in Europe and in the United States.

Also, I have attached some important questions that the answers should be written in the paper and an example, so you can take a look. Also, the reference should be the same as in the example.