Here are the definitions of acronyms that appear on this message board:
AA — Alcoholics Anonymous — A voluntary organization that helps alcoholics recover.
Ad Comm — Advisory Committee of FDA — FDA (Food and Drug Administration) committee that advises on the approval of new drugs.
ADCS-ADL — Alzheimer Disease Assessment Scale - Activities of Daily Living — An analysis technique that quantifies the activities of daily living, in the presence of Alzheimer’s disease.
ADAS-Cog — Alzheimer Disease Assessment Scale- Cognition — An analysis technique that quantifies the status of cognition, in the presence of Alzheimer’s disease.
AGM — Annual General Meeting — An annual meeting of the shareholders of a corporation.
AVXL — The stock ticker symbol of the shares of Anavex Life Sciences Corp.
BIIB — The stock ticker symbol of Biogen Inc. The company owns, sells drugs for treating neurological and neurodegenerative diseases; a potential Anavex Life Sciences Corp competitor.
BLA — Biologics License Application — A formal request to introduce, or deliver for introduction, a biologic product into interstate commerce; after the drug has been approved by the FDA.
BTD — Breakthrough Therapy Designation — An FDA process to expedite the development and review of drugs intended to treat a serious condition, with preliminary clinical evidence that the drug may demonstrate clinically significant improvement over available drugs.
CC — Conference Call — A telephone call in which someone talks to several people at the same time. Often an event at annual meetings or technical conferences.
CEO — Chief Executive Officer — The individual holding the highest management position of a corporation.
CDR-SB — Clinical Dementia Rating Scale - Sum of Boxes — A statistics methods that yields global and Sum of Boxes (SOB) scores, with the global score regularly used in clinical and research settings to quantify dementia severity.
CGI-I — Clinical Global Impression - Improvement Scale — A scale where the clinician assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
CNS — Central Nervous System — The tissues and organs in the brain and spinal cord.
CRO — Contract Research Organization — A company that provides clinical research services on a contract basis. CROs conduct clinical trials for pharmaceutical companies.
CRL — Complete Response Letter — Action by the Food and Drug Administration to a New Drug Application, indicating that the application will not be approved in its present form; but that it is approvable if certain studies are performed or more data is reported or manufacturing issues are cleared up.
CTAD — Clinical Trials on Alzheimer's Disease Conference — A periodic meeting focused on Alzheimer’s Disease Therapeutic Trials, with key leaders forming partnerships to speed the development of effective treatments to fight Alzheimer’s.
CTN — Clinical Trials Notification — This is the Australian equivalent to the FDA's IND or the EMA's Clinical Trials Application; where companies apply to be allowed to do clinical testing in their country or union.
CVR — Contingent Value Rights — In corporate finance, where certain rights are granted by an acquirer to a company’s shareholders, where some uncertainty is inherent.
DMT — Disease-modifying Therapy — A treatment that delays or slows the progression of a disease by targeting its underlying cause; as opposed to symptomatic treatments that merely treat the symptoms of a disease but do not address its underlying cause.
EHR — Electronic Health Record — A digital version of a patient’s paper chart; where real-time, patient-centered records make information available instantly and securely to authorized users.
EMA — European Medicines Agency — In the European Union the agency that evaluates and monitors human and veterinary medicines, and authorizes and approves the marketing of new medicines. Similar to the Food and Drug Administration in the U.S.
EU — European Union — The political union of the major countries in Europe.
FUD — Fear, Uncertainty, and Doubt — On this message board, a pejorative used to label posts or posters naysaying the viability or legitimacy of any Anavex topic.
GCP — Good Clinical Practice — An international quality standard, which governments can transpose into regulations for clinical trials involving human subjects.
HREC — Human Research Ethics Committee — Institutional committees that review research proposals involving human participants to ensure that they are ethically acceptable.
ICH — International Conference of Harmonization — A conference of international drug regulation bodies, such as the FDA and EMA that unifies technical requirements for the development and marketing of pharmaceutical products.
IND — Investigational New Drug — The FDA’s designation of a new drug for which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.
IR — Investor Relations — At Anavex, on its website, Investor Relations is where shareholders or the public can ask questions about the company.
IRB — Institutional Review Board — A committee at an institution that mandates research ethics for proposed research done at that institution to ensure that the projects are ethical.
JPM — JP Morgan Chase healthcare conference — Sponsored by J.P. Morgan, this is an annual health care investment conference that focuses on emerging fast-growth companies, innovative technology creators, and members of the investment community.
LOI — Letter of Intent — A document outlining the understanding between two or more parties which they intend to formalize in a legally binding agreement.
LOL — Laughing Out Loud
LPLV — Last Participant Last Visit — Results submission to ClinicalTrials.gov is a deliverable required by law for most clinical trials, for which the deadline occurs one year from reaching the primary endpoint Last Patient Last Visit (LPLV).
M1 — muscarinic acetylcholine receptor M1
MM — Market Maker — A market maker or liquidity provider is a company or an individual that quotes both a buy and a sell price in a tradable asset held in inventory, hoping to make a profit on the bid–ask spread, or turn. The benefit to the firm is that it makes money from doing so; the benefit to the market is that this helps limit price variation by setting a limited trading price range for the assets being traded.
MAA — Marketing Authorization Application — An application submitted by a drug manufacturer seeking permission to bring a newly developed medicinal product to the market.
NDA — New Drug Application — The vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
NDA — Non-Disclosure Agreement — A legal contract between at least two parties that describes confidential material, knowledge, or information that the parties agree to disclose only to themselves.
MOA — Mechanism of Action — The specific biochemical interactions by which a drug produces its pharmacological effects.
NICE — National Institute for Health and Care Excellence — In the United Kingdom, an independent public body that provides national guidance and advice to improve health and social care.
NIH — National Institute of Health — The primary agency of the United States government responsible for biomedical and public health research.
MAA — Marketing Authorisation Application —In the United Kingdom and European Union, an application submitted by a drug manufacturer seeking marketing authorization, to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
MACD — Moving Average Convergence/Divergence — A stock trading indicator used in the technical analysis of securities prices, designed to reveal changes in the strength, direction, momentum, and duration of a trend in a stock's price.
MBA — Master of Business Administration — A postgraduate degree centered on business administration.
MMSE — Mini-Mental State Examination — A 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment.
MRI — Magnetic Resonance Imaging — A medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body.
OLE — Open-Label Extension — Extended portion of a clinical study of a drug where the study is no longer blinded; where the patient, if desired, is allowed to know and take the actual drug being evaluated in the study.
OR — Odds Ratio — A statistic that quantifies the strength of the association between two events, A and B. The odds ratio is defined as the ratio of the odds of A in the presence of B and the odds of A in the absence of B, or equivalently (due to symmetry), the ratio of the odds of B in the presence of A and the odds of B in the absence of A.
P2b/3 — Phase 2b/3 Clinical Trials — Phase 2b trials specifically, rigorously test the efficacy of a drug in terms of how successful it is in treating, preventing, or diagnosing a disease. Phase 3 trials assess the effectiveness of a new intervention and, thereby, its value in clinical practice. Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective a new drug is, in comparison with current treatments.
PET — Positron Emission Tomography — An imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities including blood flow, regional chemical composition, and absorption.
PD — Parkinson’s Disease
PD — PharmacoDynamics — PD describes how drugs act on target sites of action in the body.
PDD — Parkinson's Disease With Dementia
PK — PharmacoKinetics — PK describes the movement of drug into, through, and out of the body, involving its absorption, bioavailability, distribution, metabolism, and excretion.
PTA — Post Trial Access — The providing of continued access to study interventions (drugs, etc.) once a trial is completed, or after a participant’s involvement in a trial has ended
PR — Press Release — A message or information document released to news media.
RA — Regulatory Agency — A governmental body that regulates particular technologies or programs.
RSBQ — Rett Syndrome Behavior Questionnaire — A caregiver-completed rating scale assessing a wide range of neurobehavioral symptoms of Rett Syndrome.
RSI — Relative Strength Index — An equity price momentum indicator of speed and magnitude of a security's recent price changes.
RWE — Real World Evidence — Evidence obtained from real world data, obtained outside of randomized controlled trials or is generated during routine clinical practice.
SA — Scientific Advice — The provision of scientific advice for medicines and medical devices, in European Medicines Agency.
SAP — Statistical Analysis Plan — A document that gives comprehensive instructions on statistical programming and reporting of clinical trial outcomes.
SEC — Securities and Exchange Commission — The federal agency that regulates the U.S. securities markets, to protect investors.
SOC — Standard of Care — In relation to medical therapies, the drug or therapy most commonly used, preferred, and recognized as the most effective.
SP — Share Price
SPA — Special Protocol Assessment — A legal mechanism that enables the Food and Drug Administration (FDA) to provide input into the design of certain studies critical to marketing approval of medical devices or drugs prior to initiation.
Stat Sig — Statistical Significance – A complicated statistical datum that indicates the validity of a clinical result. Results with a P-value of 0.05 or lower are considered statistically significant; that the results are not merely by chance.
TA — Technical Analysis — The prediction of future stock prices by examining price movements, charts, trends, trading volume and other factors.
TGA — Therapeutic Goods Administration — Australia’s equivalent of the US FDA, which approves drugs.
TGD — The Good Doctor — A superficial reference to Dr. Christopher Missling, Anavex CEO.
TLD — Topline Data — A summary of demographic data, the data for the primary endpoint(s), the data for any secondary endpoint(s), and a summary of safety data, of a clinical trial.
TLR — Topline Results — No actual definition of this clinical results term can be found. There is a wide variety of definitions.
WGT — We Got This — A phrase applied to those who support or have exuberant perspectives on Anavex Life Sciences Corp.
XBI — An exchange-traded fund that tracks the performance of the biotechnology segment of the S&P Total Market Index.
