Ann: Response Lodged to EMA 180 Day Review Questions, page-18

"EMA brought forward some routine questions for TIS that normally get answered AFTER approval has been given"

Yes this bit has had me thinking that it could effectively shorten the time between CHMP positive opinion and EMA CE Mark approval. I thus I quoted a typical time of that interval (2 mts) - but YES that could be shortenered to an EU administrative tick & gazette time (weeks?). However as upbeat some signs appear - they could just want more detail to pick the eyes out of, with the TIS application.