EMA, page-12

I am not so confident. I think we are at a mid point in the process and more information required.

THE GLOSSARY OF TERMS - on the EMA website.

List of outstanding issues

A set of questions addressed to a company during a procedure, such as the evaluation of a marketing-authorisation application. Lists of outstanding issues are prepared after a company has already responded to a list of questions.

list of questions

A set of questions addressed to a company during a procedure, such as a marketing-authorisation application.

-----------
Other items on the agenda seem to indicate they are further through the process. For example the agenda item 2 above our own states "OPINION" which seems to me the device will be either approved or not......

Its all semantics in wording and this is merely my interpretation.

I hope I am wrong.