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Re: Investor2014 post# 465867

Wednesday, 07/31/2024 8:09:01 AM

Wednesday, July 31, 2024 8:09:01 AM

Post# of 517083
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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