Ann: Response Lodged to EMA 180 Day Review Questions, page-16

Well, pre-open is looking good this morning at 910am.

Another factor to remember - EMA brought forward some routine questions for TIS that normally get answered AFTER approval has been given. This was done in the light of the December to January delay that the EMA asked for.

This little piece of information is telling. It says to me that TIS has got a very good chance of getting approval. If the EMA were waiting for answers that were of a complex nature, or alluded to the safety/efficacy of the product, they wouldn't have brought these routine questions forward. They would have made sure TIS has answered questions to their satisfaction, THEN asked the routine post approval questions.