Phil Davis great postI will only interject that the New FDA chief has a mandate to speed up the process. Therefore, it is possible that timelines that have never been used before may be tried. What might seem like a special situation before could become the norm. They will never venture very far from "safety first" however, it would seem that if nine of nine have no sae's that it might be a situation where things may go faster than in the past. I appreciate you explaining the mindsets and processes to us. I only offer you my humble opinion to further the discussion