ACAD presentation, page-4

I have listened to Acadia's presentation at the JP Morgan conference and there was a question about trofinetide's NDA submission namely "their confidence and ability to file based on Lavender study alone and earlier regulatory meeting they may have had" ...
Serge's answer was that "we are very confident in the strength of our trofinetide data and in regard to the discussions with FDA and expectations, YES" (the answer to the question is Yes) ...He reminded that "Lavender study design and co-primary endpoint were agreed with FDA at the end of phase 2 meeting and in fact FDA recommended to make both RSBQ and CGI-I as co-primary endpoints in the study in order to provide the level of internal validation of the meaningfulness of the results in being statistically significant.Therefore we feel very confident in our planning to further re-iterate what will be included in our submission in the upcoming pre-NDA meeting with FDA which we expect to occur this quarter. And I would say that, actually, we also had a pre-pre-NDA meeting where we also discussed even in the advance of the Lavender study results, discussed the package for the FDA. So we have a very good ongoing dialogue with FDA and I'm looking forward to our submission mid-year".

I have tried to reproduce his exact words, so there are some grammatical errors in there or misunderstandings from my side.

A link to the webcast is on Acadia's website ... Events & Presentations | Acadia Pharmaceuticals Inc. (acadia-pharm.com) or
Webcast - 40th Annual J.P. Morgan Healthcare Conference (metameetings.net)
Question time stamp 36:25