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Thursday, January 18, 2024 2:54:53 PM
sorry I lost spaces between texts as I cut & pasted
Ad Comm Advisory Committee of FDA
ADCS-ADL Alzheimer Disease Assessment Scale- Activities of Daily Living
ADAS-Cog Alzheimer Disease Assessment Scale- Cognition
AGM Annual General Meeting
BLA Biologics License Application
BTD
CNS Central Nervous System
CRO Contract Research Organization
CRL Complete response letter.
This is a response from a regulatory agency after submitting the NDA saying the drug is not approved but that it is approvable
if certain studies are performed or more data is reported or manufacturing issues cleared up.
CTN Clinical Trials Notification. This is the Australian equivalent to the FDA's IND or the EMA's Clinical Trials Application. Based on pre-clinical studies including PK/PD, toxicity, carcinogenicity, teratogenicity, etc and any human data if available, companies apply to be allowed to do clinical testing in their country or union.
DMT disease-modifying therapy
EHR Electronic Health Record
EMA European Medicines Agency
GCP Good Clinical Practice
HREC Human Research Ethics Committee
ICH International Conference of Harmonization. Regulatory agencies from practically all countries have now signed on to use standards and guidelines developed by the ICH and in accordance with GCP (also formalized Good Clinical Practice) to perform clinical studies. A clinical trial in the US is performed practically the same in the EU or AU allowing international large studies. Regulatory agencies use different abbreviations around the World and may have some built in requests but the clinical trial is performed nearly the same in all countries.
IND Investigational New Drug
IRB Institutional Review Board
LPLV Last participant's last visit
MAA Marketing Authorization Application
NDA New Drug application. The FDA and TGA use NDA and EMA uses
NDA Non-Disclosure Agreement
NICE National Institute for Health and Care Excellence(England)
NIH National Institute of Health
MAA Marketing Authorization Application (for EMA? ; comes after SA)
this is the application including detailed data from all studies that will be evaluated by the regulatory agency to decide if the drug can
be approved and marketed.
MMSE Mini-Mental State Examination
MOAs Mechanisms Of Action
MTD
OLE Open-Label Extension
OR. Odd Ratio
PDD Parkinson's Disease With Dementia
PK/PD
PTA Post Trial Access
RSBQ Rett Syndrome Behavior Questionnaire
RWE Real World Evidence
SA Scientific Advice (for EMA : European FDA)
SAP Statistical Analysis Plan
SPA Special Protocol Assessment
stat sig statistical significance
TGA Therapeutic Goods Administration (FDA equivalent of Australian government)
TLD Topline Data
TLR Topline Record
Recent AVXL News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/12/2024 09:45:00 AM
Element79 Gold Corp Appoints Warren Levy to Board of Directors • ELMGF • Aug 28, 2024 9:51 AM
Integrated Ventures Announces Strategic Entry Into Health & Wellness Industry with Focus on GLP-1 Products • INTV • Aug 28, 2024 8:30 AM
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PickleJar Unveils Latest Venue Managed Services Innovations in Upcoming Webinar • PKLE • Aug 23, 2024 1:11 PM
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