![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Monday, June 03, 2019 4:44:16 PM
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.
Recent AVXL News
- 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
- Anavex Life Sciences to Present at the Noble Capital Markets Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
- Anavex Life Sciences Corporation Class Action: The Gross Law Firm Reminds Anavex Life Sciences Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 13, 2024 - AVXL • PR Newswire (US) • 04/05/2024 09:45:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
FEATURED Nightfood Holdings Signs Letter of Intent for All-Stock Acquisition of CarryOutSupplies.com • Jul 17, 2024 1:00 PM
Kona Gold Beverages Reaches Out to Largest Debt Holder for Debt Purchase Negotiation • KGKG • Jul 17, 2024 9:00 AM
Avant Technologies Welcomes Back Former CEO with Eye Toward Future Growth and Expansion • AVAI • Jul 17, 2024 8:00 AM
HealthLynked Expands Telemedicine Nationwide • HLYK • Jul 17, 2024 8:00 AM
Peer To Peer Network aka Mobicard™ Launches AI Investor Chatbot Boosting Engagement & Lead Generation on Ihub • PTOP • Jul 15, 2024 8:30 AM
Greenlite Ventures Announces AI Integration into No Limit Platforms • GRNL • Jul 15, 2024 8:00 AM