Replies to post #173275 on Anavex Life Sciences Corp (AVXL)

[blanka]

Looking GREAT!!!

PATIENCE WINS AVXL

[plexrec]

"patients 18 yrs and older"--is this new ??? I thought this was going to involve "young patients' !!!!!!

[XenaLives]

WOW - wasn't really expecting that..

Perhaps the FDA was willing to be more relaxed about 18 or over. If successful off label for kids will be allowed.

"Other Outcome Measures" are telling IMO they support the universal CNS theory.

Other Outcome Measures:
Anxiety, Depression, and Mood Scale (ADAMS) [ Time Frame: 7 weeks ]
Anxiety, Depression, and Mood Scale (ADAMS)

Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: 7 weeks ]
Children's Sleep Habits Questionnaire (CSHQ)

Visual Analog Scale (VAS) [ Time Frame: 7 weeks ]
Visual Analog Scale (VAS)

Seizure Frequency via seizure diary [ Time Frame: 7 weeks ]
Seizure Frequency via seizure diary

Genetic variant SIGMAR1, COMT [ Time Frame: 7 weeks ]
Pre-specified endpoint

Glutamate Plasma Concentration [ Time Frame: 7 weeks ]
Biomarker

GABA Plasma Concentration [ Time Frame: 7 weeks ]
Biomarker

[Amatuer17]

Finally we see the trial on official site
Highlights

Primary completion - Oct 2019
Study completion - Nov 30 2019

So the results will not come before Dec 2019 - it is 12 months - not by Jun 2019 as some were predicting

2. Age above 18 - interesting - so no pediatric study - all big deal about kids suffering and need of immediate medicine is thrown out of window

3. Exclusion criteria - not taking other medicine - this will slow the enrollment as the patient population is small and many are already enrolled in other trial.

What happened to quick enrollment and patient being ready?
Well one can speculate anything - the reality bites and shows that Anavex operates in same environment as others and has no fast tracks.

[Investor2014]

Wonder what a dose of "1 ml orally" actually means in terms of A2-73?

Seizure a tertiary outcome measure.

[Jonjones325]

Ok. So does this mean, the 12 week trial starts after this one is finished in October 2019?

Obviously the trial could end much sooner. I guess they have to put a reasonable timeline out.