I believe that when they say 150, they count every day, weekends and holidays included. In short It's a 5 month period which without any questions to answer, beats the US by a month. Not saying that is the goal, it's normal to have at least 1 RFI, so 7 months is far more likely for faster approvals. 9 months should allow for 2 RFI's.
I believe that far more is happening here, and the added time may be in consideration of a tumor agnostic label and the EDEN Unit to produce it. It may not be successful, but if that's what has taken the time, I think it's worth the try.
Gary