I am not aware either, just my conjecture. I’m not a pharma expert, just an educated guess that their investigator may be throwing this at them to either further rationalize the skipping of a step, emergency use, or to substantiate a claim they are attempting to make. I only have limited experience with the FDA device side, not pharma, but in going through that process your investigator can ask anything of you and you must do it and substantiate it in the process or explain why their thinking is not correct.