Very impressive results with a small N of 2 with F

Very impressive results with a small N of 2 with FDA reading news. He must be careful in his statements before approval. I remember reading the fda sent a letter to another ceo claiming drug results before approval. His statement here is directly referring to enough results to apply for btd, which the fda may disagree on, even though these people in emergency setting are in dire need, the fda may say, no, not enough.