Well, it is not that is doesn't apply Veloyt, it is just that the same historical steps & procedures are not necessarily applicable because this is not a typical case. The IND process is still what it is. It's just that there is a bit more to it with the treatment being so extraordinary.
You go to the dentist for a routine cleaning and schedule the appointment as such. However, upon the routine cleaning, that gal with the perty smile discovers something that was not there six months ago and that routine cleaning turns into an appointment for a gum biopsy and so on and so forth.