Anavex Life Sciences Corp (AVXL)

[sokol]

Yes, patients, caregivers, and health care providers all had positive comments including modifying the disease, becoming motivated and functional again - reading, painting, woodwork(?), etc. Real World Evidence. The following is some of what I posted before, but it it relevant to the find by TTT (thank you TTT):


It appears that 2020 may be the big year for Anavex and AVXL 2-73!

AVXL 2-73's Chances of Approval:

Numerous Scientific Publications are Supportive for AVXL 2-73

AVXL 2-73 Animal Studies Confirm the Scienific Liturature

AVXL 2-73 Human Clinical Trials Confirm the Science and Show Promise

Real World Evidence is Supportive

The Anavex and Ariana Comparitave Study of Patients from Anavex’s AD trials and AD Patients from the ADNI Data Base is Positive.

As of the end of 2019, around 400 or so patients will have participated in AVXL 2-73 clinical trials for AD, PDD and Rett. Some of those patients are placebo patients. It may be that this time next year there will be 600 or more patients participating in Anavex’s clinical trials. However, Anavex may be expanding the clinical trials. PDD clinical trial results may be available mid 2020.

Slides from Anavex's most recent presentation:

“FDA’s new Real World Evidence Program Likely to have a Profound Impact on the Biopharma Industry” was the first slide in the most recent Anavex presentation wherein Anavex and Ariana did a comparitave placebo mimic study using patients from Anavex’s AD trials and patients from the ADNI data base.

The slide entitled “Use of Real World Evidence in Regulatory Settings is Gaining Momentum” from Anavex’s recent presentation mentions one drug, Blinatumomab, approved by the FDA with supporing Real World Evidence. That slide lists reasons and benefits for using Real World Evidence together with results from clinical trials:

• Collection of real-world data is not new
• May provide access to patients that may not have been considered in a clinical trial
• Ethical question of unnecessarily exposing patients to placebo
• Reducing size, duration and costs of trials
• Accelerating regulatory path

See the slide "ANAVEX®2-73 Selective Sigma-1 Receptor (SIGMAR1) Agonist Demonstrated Improved MMSE1 and ADCS-ADL2 Scores in Phase 2a AD Study through 148 Weeks" If this and other type of improvement (such as improved gut microbiota*, etc.) continues into 2020 with significant numbers of AVXL 2-73 treated patients, 2020 could be the big year for Anavex.
* "Communication between gut microbiota and the brain has been shown to be a critical requirement of a healthy brain function. The reduction in gut microbiota diversity has become one of the hallmarks of aging, and disturbances in its composition are associated with several age-related neurological conditions, including Alzheimer’s disease....”
Giau, V.V.; Wu, S.Y.; Jamerlan, A.; An, S.S.A.; Kim, S.; Hulme, J. Gut Microbiota and Their Neuroinflammatory Implications in Alzheimer’s Disease. Nutrients 2018, 10,
1765
https://www.anavex.com/anavex-life-sciences-presents-new-clinical-data-identifying-gut-microbiota-biomarkers-associated-with-improved-clinical-response-in-patients-treated-with-anavex2-73-at-2019-alzheimers-a/