They did go the route of the hand holding by the FDA, so why wouldn’t the FDA give the thumbs up on the ide after the rabbit testing showed being within the limits the FDA set.
Ask this question. Did the fda tell the Mayo to go ahead with training or was it the Mayo that decided to do the training.
Start connecting the dots in my opinion we are a lot closer to ide approval than most think.
Also when ide application is submitted the fda can approve and or deny anytime after application is submitted. So technically the FDA could approve IDE the first day.