Does anybody know? I am hoping that there is a PR once ELN gets the IND. But if not, then I hope they will issue PR at the start of Phase I, so I was wondering if its immediate or after weeks when phase I starts?
not sure if someone answered this but IND is needed for phase one trials. The reg agency has 30 days to respond. If they don't, it's a green light. then trials can start asap subjects are available. Hope this helps.