There are two types of risks in this field:

1. Approve something too soon. This kills/hurts patients using it.

2. Wait too long approving something. This kills/hurts sick people who are deprived of good treatment.

The classic big FDA flaw is to heavily lean towards type 2 errors, because type 1 deaths lead to bad PR, while no one notices type 2 errors.

So that EMA apparently made a type 1 error here is possibly a good sign!