Glossary

The terms a reader meets in the briefing, each with what it is, why it matters here, and the issues that use it.

• BfArMThe BfArM, in full the Bundesinstitut fur Arzneimittel und Medizinprodukte or Federal Institute for Drugs and Medical Devices, is Germany's national medicines regulator, and it also runs the country's narcotics oversight and its public compassionate use register.
• CHMPThe Committee for Medicinal Products for Human Use, or CHMP, is the European Medicines Agency committee that assesses a marketing application and issues the scientific opinion the European Commission then turns into an EU-wide authorisation.
• CTISThe Clinical Trials Information System, or CTIS, is the European Union's single portal for applying to run a clinical trial and for publishing it, and each record lists the member states whose regulator has taken a decision on the trial and the sites in each.
• CVRA contingent value right, or CVR, is a promise by a buyer to pay the sellers a further sum only if a named event happens by a named date, so the headline price of a deal that carries one is a ceiling and not a payment.
• EMAThe European Medicines Agency, or EMA, is the European Union's central medicines regulator: through the centralised procedure it evaluates whether a medicine may be sold across the EU and EEA, and it has no say in what any country then pays for it.
• GADGeneralised anxiety disorder, or GAD, is persistent and excessive worry that the person cannot control, and it is the indication in which Definium ran its two Phase 3 trials and one of the three Qualifying Indications in the AtaiBeckley CVR agreement.
• MADRSThe MADRS, in full the Montgomery-Asberg Depression Rating Scale, is a ten-item clinician-rated measure of depression severity scored from 0 to 60, where a higher score is worse, and it is the scale almost every trial in this field is judged on.
• MDDMajor depressive disorder, or MDD, is the clinical diagnosis of depression itself, the broad population from which treatment-resistant depression is drawn once two adequate courses of antidepressants have failed.
• NDAA 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.
• Open-labelAn open-label trial, also written open label, is one in which nobody is blinded: the patient and the investigator both know who is getting the drug.
• Pivotal trialA pivotal trial, sometimes called a pivotal study, is industry shorthand rather than a regulatory term: it means a trial a company intends to serve as one of the adequate and well-controlled investigations that support an approval decision.
• Placebo-adjustedA placebo-adjusted result, also written placebo adjusted, is the gap between the drug arm and the control arm of a trial, not how far the drug arm improved on its own.
• Primary endpointThe primary endpoint, called the primary variable in regulatory guidance and sometimes the primary outcome measure, is the single measurement a trial is designed and powered to answer, fixed in the protocol before anyone is unblinded.
• Rolling reviewA rolling review, also called a rolling submission or a rolling NDA, lets a company file completed sections of a New Drug Application as each is finished, rather than holding everything back until the whole application is ready.
• Treatment-resistant depressionTreatment-resistant depression, usually shortened to TRD, is major depressive disorder that has not meaningfully improved despite adequate doses of at least two different antidepressants, each taken for long enough and with adherence confirmed, which is the European Medicines Agency's definition rather than a universal one.
• WashoutA washout, also written wash-out, is a required period in which a trial participant comes off their existing antidepressants and stays off them before the trial drug is given.