Your insight is dead on. Too many people are read

Your insight is dead on. Too many people are reading too, too much into the vague language of NP re the FDA's intentions. The FDA does not give fatherly advice to BLA candidates. Methinks NP simply bought into the notion that too many einds leads to too few trial participants - a self defeating pracice for a BLA candidate in a hurry. Ergo less einds and more trial participants.