InvestorsHub Logo

Investor2014

03/24/24 5:15 AM

#454855 RE: Investor2014 #454854

Meant do NOT have the reference to hand.

frrol

03/24/24 10:37 AM

#454863 RE: Investor2014 #454854

From the Q4 2023 call, the company said it was pursuing "full approval" under the EMA comprehensive procedure. So if approved, we would not have to submit data from a confirmatory study at a later date (it's 'permanent'). It's good to see. I do not know if our MAA will include OLE data. 52 week data from that should be available about the time we submit.