This is an exciting week for us as we should have a good idea by...

This is an exciting week for us as we should have a good idea by the end of the week of how our application is travelling at the EMA. The Committee for Medicinal Products for Human Use has their monthly meeting for the first 4 days of this week and by the end of it they should have decided on a list of questions to be answered by TIS and BSI.

I expect there to be an announcement either at the end of this week or early next week to the effect that the list of questions has been received. I assume it will be sent directly to BSI and then be forwarded on to TIS. Hopefully both will be well prepared and be able to respond to the list within weeks if not days and then the clock will be restarted for what is hopefully the last time.

GLTA
Rev