Anavex Life Sciences Corp (AVXL)

[XenaLives]

Compiled:THE U.S. FDA: 09/29/19
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FDA In Brief: FDA begins reorganization phase of modernization efforts to increase efficiency and further support new drug development (from kevli33)
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-begins-reorganization-phase-modernization-efforts-increase-efficiency-and-further

FDA Quality control issues:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151135064

5/8/19 FDA GENERAL CONSIDERATIONS FOR CLINICAL STUDIES:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150245171

"FDA is very primed to approve a drug for Alzheimer disease"
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150326008

A US sponsor conducting trials internationally is now very common and the FDA themselves says there is "Less regulatory red tape".
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150986350
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150986438

Delivering Promising New Medicines Without Sacrificing Safety and Efficacy
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150792210
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150792275

Link to guidance doc on ALS just released
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151298762

FDA In Brief:
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications 7/31/19 (from kevli33)
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-european-medicines-agency-collaborate-drug-quality-and-manufacturing-data-improve

FDA position-guidance on (EHR) records and tool uses. ( from nidan7500 )
https://www.fda.gov/files/drugs/published/Electronic-Technologies-in-Clinical-Trials---2.pdf

Janet Woodcock, FDA, on future innovation in drug development

Comments on the above
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149424734

Gottleib - former FDA commissioner on CNBC on what he believes is an area of HUGE potential.
Start listening at 4:00 minute mark (from Lima4918)
https://www.cnbc.com/video/2019/06/17/fmr-fda-commissioner-on-biotech-cannabis-and-the-meatless-markets.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard

Coming change in FDA process - the office of innovation (Office of Drug Evaluation Science) 1/8/19:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145956816
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145966349

Will Fadiran negotiate a SPA with the FDA?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149960752

FDA leaks, a time honored tradition:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140883830

On what planet does the FDA put the health of the people first?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140058548

The FDA, pay for play, and peer review:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141334023

3/14/19 Update from Gottlieb on changes in drug trial procedure
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147558978

New(Feb 2019) guidance highlights basis for possible early approval of 2-73:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146543702

This could speed up and simplify and reduce cost of “precision enrollment” screening time:(from biostockclub)
https://neurosciencenews.com/artificial-intelligence-alzheimers-13097/

“The Future of Drug Trials Is Better Data and Continuous Monitoring” (from kevli33)
https://hbr.org/2019/05/the-future-of-drug-trials-is-better-data-and-continuous-monitoring

Alzheimer’s Disease conference, held October 24–27 2018 in Barcelona, Spain,
Which Are the Right Tests to Satisfy New FDA Guidance?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145129244

Changing FDA perspective toward trials and electronic data collection.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149099899

How RWE data will be used and new systems will be applied. (from nidan7500)
https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf

Precedents and legal pathways to approval from Biostockclub & Nidan:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145205166

New FDA accelerated approval guidance for labeling - from Nidan7500
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf

FDA planning new guidance, hires in cell and gene therapies for 2019 (From basparks79)
https://www.fiercebiotech.com/biotech/fda-planning-new-guidance-hires-cell-and-gene-therapies-for-2019

Link from the above post naming precedents for drug approval without a Random Controlled Trial:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/#!po=95.1923

New Rare Disease Draft Guidance (Feb. 2019 from nidan7500)
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629579.pdf?rel=0

Electronic Health Records to be used in FDA trials (from Rubyred77)
https://ehrintelligence.com/news/ehr-data-to-provide-real-world-evidence-for-clinical-trials

New guidance for early stage Alzheimer's being developed in the U.S.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145205259
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145208035

What is a Special Protocol Assessment?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140087471

Check this out on retrospective validation: (from Nidan7500)
https://www.nature.com/articles/6500363#hypothetical-safety-example-seeking-drug-approval-in-the-dnasubgroup-of-patients-with-less-risk-of-a-cardiovascular-adverse-events-after-trial-completion

4/3/19 - New position paper from FDA on AI supports Cognision partnership
(see Anavex Partners link at bottom of post for more on Cognision)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147990271

A 1995 paper predicts loss of U.S. credibility in drug approval:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145668454

Alzheimer's research receives largest ever funding boost in 2019 budget
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143880556

Are blinded, placebo trials really necessary?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147253537

Is corporate dominance of the FDA achieved by the User Fee Act (PDUFA)?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147227616
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147231843
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147234966

New programs to promote drug manufacturing innovation anounced by Gottleib(from Kevli33)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631293.htm?utm_campaign=021319_Statement_FDA%20announces%20programs%20to%20promote%20adoption%20of%20innovations%20in%20drug%20manufacturing&utm_medium=email&utm_source=Eloqua

Woodcock says the clinical trial system is broken. (From nidan7500)
https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/

Did the FDA cause the opioid crisis (from tradeherpete)
https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/?ftag=MSF0951a18

On ACTC participation in the U.S.:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144487503
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145208260

Why ACTC is the holdup in North American Alzheimer's trials:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145449081

Update on NIH/ACTC (from Talon38)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147089795

Anavex, ACTC and Paul Aisen:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147089981

The pace of NIH-ACTC movement is Glacial. (from Nidan7500)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147091783

CDER expediting drugs - post from 04/08/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148080157

Payers and Right to Try:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148132893