Anavex Life Sciences Corp (AVXL)

[XenaLives]

Compiled: TRIAL PROCEDURE OTHER COUNTRIES and GENERAL COMMENTS: 08/08/19
________________________________________________________________________________________________________

The weaker the signal the higher the n or trial participants needs to be to show Stat Sig.
https://investorshub.advfn.com/boards/read_msg.aspx?mmessage_id=150305920

Novel trials designs such as “basket,” “umbrella,” etc
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150179911

Procedure and implications of post trial access to drugs:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149179546
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149180303

Sponsor has an obligation to monitor the trial as well as ensuring the Investigator is following protocol
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149408725

When to Stop a Clinical Trial Early for Benefit
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149768695

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

Multi-regional clinical trials and global drug development - 2016 changes in trial technique:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149099281
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149099929
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149100322

As of January Anavex has a QPPV- needed for EU approval. (from TTTav66)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146643593
Qualified Person Responsible For Pharmacovigilance - Wikipedia
https://en.wikipedia.org/wiki/Qualified_Person_Responsible_For_Pharmacovigilance

Expedited approval in Asia
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145657979
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145658475

An example of provincial level drug approval in Canada: (from nidan7500)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148351451

Japan:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148770129
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148770231
Japanese accelerated approval:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148389943

Reasons why it's good to be running trials in Australia...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140883830
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147033379


Patient Centricity And Social Media Are Changing Patient Recruitment (from Kevli33)
https://www.clinicalleader.com/doc/patient-centricity-and-social-media-are-changing-patient-recruitment-0001

PDD/AD trials in Australia/Spain-Australia and EU can exchange scientific information:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148650906
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148655115

A Brief History of Placebos and Clinical Trials in Psychiatry
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148139761

indialong cites FDA gidance concerning need for placebo in studies:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148154841
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148154913

TempePhil gives us links to all three Anavex trials:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146017758

TTTav66 analysis of trial recruitment and enrollment figures:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145420519

Worst case enrollment figures:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146083304

2-73 preclinical improvement of learning and behavior:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147390935

A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings (from nidan7500)
https://www.dadm.alzdem.com/article/S2352-8729(15)00070-6/fulltext

Will Canada give Conditional Approval if Australia does?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148221699

How enrollment works:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144955802

Precision Medicine and “The Economics of Drug Development”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144010889

A "sobering read" on precision medicine from Investor2014
https://blogs.sciencemag.org/pipeline/archives/2019/01/31/precision-medicine-real-soon-now

Trial interpretation - What’s in a p value? - a significant read! (from Investor2014)
http://www.evaluate.com/vantage/articles/analysis/vantage-views/whats-p-value

On dosage of 2-73 and P values:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144631198
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144495639

Infantile Spasms Market analysis:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147347329

Rett Syndrome Market Analysis:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147347491