What is the sentiment in regards to this? I know the EMA isn't quite the rubber stamp that the FDA has been recently, it tends to be more picky with the meds it approves or disapproves. Though basal cell carcinoma treatment is definitely novel, especially advanced stage. I think its quite likely that this gets ruled on in February.
Picky yes! Less political BS though! Watch for this drug via the Feb EMA PRAC meeting results first!
If its been 14 months then its really overdue. Why so long--has the EU clock stopped along the way given their process for questions asking for response? Usually the EMA works more like clockwork than the FDA and their PDUFA system!