Trofinetide and ACP-204 are investigational agents, and the safety and efficacy of these agents have not been established. There is no guarantee these investigational agents will be filed with or approved by any regulatory agency.
I think you’re reading far too much into this.
This is simply saying that trofinetide (along with ACP-204) is an investigational drug – that is, it has received an IND to be tested in humans but it is yet to receive marketing approval from the FDA. Only after approval is received by the FDA can one safely say that safety and efficacy is established.
And to make doubly sure that their a… is covered, Acadia reminds everyone that there is no guarantee that trofinetide will be approved by any regulatory agency.
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