RE:Type C Meeting TimingsGreat news....truly. I think the FDA will accomodate a meeting within a month and a half.
I'm guessing this means ONC met key performance leaders? No guidance yet on proposed target population and use of markers. I'm guessing the Pela combo does better than ADC treatment in overall response rate and safety. As I recall they never reported bracelet stats for markers. The trial design perhaps blew marker analysis because half the population likely with stronger treatment responses withdrew from heavy flu symptoms. So they still may need to prove the marker utility.