Which PR did they say that in? To me I think the EMA at the very least go with a conditional approval. These are the general guideliens for phase 4 studies:
There's substantial evidence of the drug's efficacy and safety, but more data is needed to confirm or expand on these findings. The drug addresses a serious or life-threatening condition where available treatments are limited. The potential benefits of immediate access to the drug outweigh the risks of unknown long-term effects.
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