Next issueIssue 16 · Tue 29 Sep 

Glossary

NDA

A New Drug Application, or NDA, is the filing a company makes to the US Food and Drug Administration asking permission to sell a medicine, and it is the only marketing application Compass Pathways has said it is preparing for COMP360.

Why it matters here

An NDA is an American document and says nothing about Europe, so in our opinion a company whose regulatory language is NDA, FDA and DEA and nothing else has told you where it is going and where it is not.

Compass's 9 September 2026 release states that its rolling NDA submission is under way with final submission expected in the fourth quarter, and names no European regulator (Compass Pathways, 9 September 2026). That is the fact behind our open call 9.

Where it appears