Hi GL, Again I preface my response based on my understanding....

Hi GL,

Again I preface my response based on my understanding.

TIS was given a list of questions back in January after the CHMP meeting that month. TIS spent a great deal of time answering those questions (presumably in as detailed a way as possible) and submitted those answers at the end of July. After that the EMA embarks upon a process to assess those answers. There is no provision in their processes to ask further questions until the scheduled time to send a list of outstanding issues which would be endorsed at their meeting in 2 weeks (probably).

I think you are asking "can they ask further questions between the time we submit our responses to their original questions and the scheduled time for sending us a list of outstanding issues?" My answer to that question is "no, not to my understanding."

Hope this answers you question.

Rev