RE:AA Application process and best practiceThe way our trial is designed we actually fit well into the vision and policy that the FDA has in mind. We can use our interim data to get AA and continue the trial to completion to assess Response. No need for another trial. (but see below)
As this letter states: "as we propose in the paper, a single trial could be designed to support accelerated approval based on an interim analysis of response rate, as an example, and subsequently verify clinical benefit based on survival".
In addition this letter confirms that the FDA would support and encourage a separate trial to assess our efficacy as a primary frontline means of treatment. That would open up a much larger patient population and $$$. I believe this is where the additional 9 sites comes into play at some point down the line.