FDA, page-110

I recall Steve Davis, Acadia's CEO, saying during presentations this year that their communication with the FDA has continued to be very good and that he didn't have any reason to be concerned about the approval process.

Also back in NEU's ASX announcement it was mentioned:
"The FDA has also informed Acadia that at this time they are not planning to hold an Advisory Committee meeting."

https://www.ncbi.nlm.nih.gov/books/NBK236088/
Extract:


This suggests to me that the safety and effectiveness data submitted by Acadia must have been clearly documented and easy to understand without further consultation by those charged with making the important approval decision.

As pointed out by others previously, the adverse effects of other FDA recently approved drugs appear to be much more substantial than those encountered during the Trofinetide trials.

So I am hoping this all points to the good news of Trofinetide by the FDA soon.

GLTAHs