Home > Boards > US Listed > Biotechs > Anavex Life Sciences Corp (AVXL)

Thanks jonjones325:

Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
nidan7500 Member Profile
 
Followed By 19
Posts 4,796
Boards Moderated 0
Alias Born 09/21/16
160x600 placeholder
Anavex Life Sciences Announces Achievement of Enrollment Target for the ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s Dis... GlobeNewswire Inc. - 1/27/2020 7:00:10 AM
Anavex Life Sciences Issued New U.S. Patent for ANAVEX®2-73 Treatment of Neurodevelopmental Disorders including Rett Syndrom... GlobeNewswire Inc. - 1/8/2020 7:00:10 AM
Anavex Life Sciences Reports Fiscal Year 2019 Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 12/16/2019 7:00:10 AM
Anavex Life Sciences to Announce Fiscal 2019 Year End Financial Results on Monday December 16, 2019 GlobeNewswire Inc. - 12/10/2019 7:00:10 AM
Citation Growth Corp. (OTCQX: CGOTF) Weathering the Cannabis Downturn InvestorsHub NewsWire - 12/9/2019 7:23:11 AM
Anavex Life Sciences Presents ANAVEX®2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Con... GlobeNewswire Inc. - 12/4/2019 7:00:10 AM
Anavex Life Sciences Receives Rare Pediatric Disease Designation from FDA for ANAVEX®2-73 (blarcamesine) for the Treatment o... GlobeNewswire Inc. - 11/14/2019 7:00:00 AM
Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Rett Syndrome GlobeNewswire Inc. - 11/6/2019 7:00:00 AM
Anavex Life Sciences Announces ATTENTION-AD ANAVEX®2-73 Extension Clinical Study in Early Alzheimer’s Disease GlobeNewswire Inc. - 10/9/2019 7:00:00 AM
Anavex Life Sciences Issued New U.S. Patent for Composition of Matter Covering ANAVEX®2-73 for the Treatment of Alzheimer’... GlobeNewswire Inc. - 10/2/2019 7:00:00 AM
Anavex Life Sciences Presented at the 6th Annual European Rett Syndrome Conference Preliminary Clinical Efficacy Data from th... GlobeNewswire Inc. - 9/27/2019 3:00:00 AM
Anavex Life Sciences to Present at the 2019 Cantor Fitzgerald Global Healthcare Conference GlobeNewswire Inc. - 9/26/2019 7:00:00 AM
Notice of Effectiveness (effect) Edgar (US Regulatory) - 9/23/2019 6:35:19 AM
Anavex Life Sciences to Present at the Ladenburg Thalmann 2019 Healthcare Conference GlobeNewswire Inc. - 9/18/2019 7:00:00 AM
Post-effective Amendment to Registration Statement (pos Am) Edgar (US Regulatory) - 9/17/2019 5:16:10 PM
CLS Holdings (CLSH) $1.15 Price Target - MASS Approval for Recreational License InvestorsHub NewsWire - 9/17/2019 7:17:00 AM
Withdrawal of Registration Statement (ammendment) (aw) Edgar (US Regulatory) - 9/16/2019 4:17:42 PM
Anavex Life Sciences Announces Preliminary Clinical Efficacy Data of its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patie... GlobeNewswire Inc. - 9/16/2019 7:00:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 9/13/2019 5:11:08 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 9/13/2019 5:07:24 PM
Securities Registration Statement (simplified Form) (s-3/a) Edgar (US Regulatory) - 9/13/2019 5:02:44 PM
Anavex Life Sciences to Present at the Janney Healthcare Conference 2019 GlobeNewswire Inc. - 9/5/2019 7:00:00 AM
Anavex Life Sciences Announces Initiation of the EXCELLENCE ANAVEX®2-73-RS-003 Clinical Study in Pediatric Patients with Ret... GlobeNewswire Inc. - 9/4/2019 7:00:00 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 8/7/2019 4:07:28 PM
Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 8/7/2019 7:00:00 AM
nidan7500   Monday, 06/03/19 04:44:16 PM
Re: Jonjones325 post# 195307
Post # of 232649 
Thanks jonjones325:
https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-Post-Trial-Responsibilities-Toolkit-Version-1.1.pdf

Text: The amount of information known about the investigational medicine (which varies by trial phase) is one critical factor in the determination of who is responsible and for what: in early phases of drug development, whether patients benefit from the drug, what risks are attendant with drug administration, and toxicity of the drug may be unknown or inadequately studied. Both while the investigational medicine is in development and while awaiting approval, the sponsor should investigate whether suitable safe and effective alternatives to the investigational medicine exist, and whether discontinuing the investigational medicine and/or transitioning to a suitable alternative could potentially harm the patient.
In general, where no such alternatives exist for a serious or life-threatening condition and when the patient has shown benefit from the product, provision of continued access is indicated.
If the investigational medicine is not approved by the regulatory agency, the sponsor must respect the local regulatory authority and discontinue provision. On very rare occasions, the sponsor may elect to engage with the government to determine if an exception may be made for the individual patient.
Where suitable alternatives exist, if the risks are significant or the product is shown to be ineffective, no further access to the investigational agent is recommended and responsibility for patient medical care will shift to the healthcare system.

I cannot imagine how the decision process driven by this document could possibly be effective under today's paper driven process conditions. A precision medicine, case by case, digital technology complimentary system would ensure technical consistency.

I would not want to do that job w/o strong systems support.


Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist