RE: When is EMA decision due?18 Mar 2024 12:30
If I recall correctly from the earnings call the company was saying Q3….There has been no indication of a priority review from EMA so my guesstimate is the process runs through against a standard timeline.
The published process is 210 days for CHMP to give a scientific opinion and then there is the European Commission approval 67 days later, which is a total of 277 working days approx 14 months (with a few public holidays). So that would be August, although that is a peak holiday period so it may be September.
~The market opportunity was shown as 3x US, JP is the same as the US…which is why 2025 should be so much better than 2024.