Anavex Life Sciences Corp (AVXL)

[nidan7500]

Good to see this, suggest it be studied carefully.
Finished commentary on preliminary PDD OLE data. As always, I may make amendments over the next 24-48 hours. https://www.sotcanalytics.com/update-compendium-2023

My Timeline Projections for 2023

As the company approaches commercialization, there are a number of key milestones I am anticipating this year. These are my personal projections and trading should not be conducted based on these timelines.

Partnership: I expect this to be nearing completion, if not completed by May. Looking forward to a partner that can assist with manufacturing, promoting, and distributing Blarcamesine worldwide once approved for Alzheimer's specifically (which of course I expect based on this 2b/3 with potential for a phase 4).

Full AD Data: I expect this to be released by April and no later than June.

Parkinson's Disease Dementia OLE Data: I expect this to be released very close to or in conjunction with the full AD data, so in April to June. I have low confidence in this particular timeline however as I believe the data is probably available at this time, so release may be quite soon.

Submissions for Alzheimer's Approval to Begin: I expect submissions to the FDA, EMA, and TGA (possibly to include the MHRA [UK] and HPFB [Canada]) by July and no later than August.

Rett EXCELLENCE Data: I expect data to be complete by June and no later than end of July. It is possible the company may wait until a relevant scientific event to release however.

Submissions for Rett Syndrome Approval in Pediatric & Adults to Begin: I expect submissions to the FDA, EMA, and TGA by September and no later than November. I have a feeling Anavex may have interest in attempting to have this indication approved in Japan as well based on previous comments by Dr. Missling.

Fragile X, Schizophrenia, PD (to include imaging trial), PDD, and Undisclosed Indication Trial Commencement: I have no projections for timelines on these trials commencing. I do expect at least 2-3 new trials to begin by the end of 2023.

Assessment: SOTC Analytics assesses 2023 as probably the most important year Anavex will have as a company. We are expecting partnerships, commercialization (or definitive notion towards beginning commercialization), and the completion of Anavex's Rett Syndrome trial suite. Considering recent influxes in investment by funds and institutional investors, as well as key developmental milestones expected, we believe the proverbial launch-pad has been set and this year likely represents the final opportunity to accumulate at discount.