Ann: Bronchitol Deferred by Australian PBAC , page-16

Below is a response I received from PXS regarding EMA process.



The EMA normally make decisions ( or at least ratify their decisions) at their various meetings. Normally, they will send a list of outstanding matters that they may seek a clarification on at their meeting. However, they may feel that a clarification meeting is unnecessary if they feel on top of things. A meeting usually last 30 minutes - so not much time to get into anything substantive.

We will be notified of the outcome after their meeting (even if we're not there).

Hope that helps. I'm looking forward to getting on with things after all this time.