Woodcock's bloomberg feb 11 speech, minute 26 to 31. In there she refers to the breakthrough designation. In particular, she refers to clinical results that are just amazing and that it would not make sense to treat such findings with the usual FDA years of phase cycles. If she isn't referring to Max she is surely referring to someone like him, maybe the ALS guy who regained function. Her voice inflection is the personal note I'm referring to.