The Bull Case VS. Bear Case on Anavex Life Sciences $AVXL

[u/SeekingAlphaToday]

Anavex Life Sciences $AVXL

• Anavex is working on novel small molecule therapies for CNS diseases, comprising Alzheimer's disease, Parkinson's disease, Rett syndrome, and additional rare diseases.
• Anavex' ANAVEX 2-73 showed promise in treating Alzheimer's, with strong efficacy in slowing cognitive and functional decline.

Upcoming catalyst:

• European approval in 2025

The bull case:

https://seekingalpha.com/article/4746655-anavex-life-sciences-jumping-in-on-time-ahead-early-alzheimers-decision

The bear case:

https://seekingalpha.com/article/4746249-anavex-life-sciences-stock-why-not-buying-bull-thesis

[u/Potential_Release478]

Stopped reading the bear case - author says it gave the stock a sell rating right before it shot up 350%!!! WTF

[u/SeekingAlphaToday → u/Potential_Release478]

I hear you. Of course, even the best investors get most things wrong.

[u/biotek_squeeze]

Thanks for posting, I don’t usually give the SA articles much credit, mostly due to the authors lack of intimate knowledge and sometimes obvious agenda, but do appreciate people trying to create awareness of this small company.

[u/biotek_squeeze]

Seeking alpha articles seriously lack DD and deep understanding of the company on both sides of the argument.

There is a lot of nuance here, given that at the time of trial initiation, the company was extremely small and frugal, but were STILL able to show success despite some shortcomings, and secured sufficient financing along the way. Furthermore this international trial started before, worked through, and was completed during and following the peak of COVID which increased the stress on all parties involved and likely contributed to an increase in dropouts at the first sign of side effects from scared fragile patients. Though they did manage to solve much of dizziness effect in the open label extension by switching the dose from morning to before bed. Furthermore they uptitrated too quickly which increased AE, since they were still working on finding optimal dosing (a phase 2 characteristic of the phase 2b/3 trial) again it was solved by lengthening the titration schedule for those of the placebo group that opted into the OLE.

many people lack this awareness/knowledge and immediately, and ignorantly, call it a scam because they see some things that would not occur in an airtight BP phase 3 trial, which this was not.

looking back at the trial, it raises questions, but if you’ve followed closely for a decade, you know the answers and explanations for most, if not all, of the unconventional/questionable aspects of the company’s choices and activities. If you don’t you think, huh, this is not right or legitimate.

IMO Just looking at the slide deck and reviewing news headlines for the past several years will not cut it, here. Much DD needed to understand the whole picture and why this is highly likely to get approved in Europe.

Extremely bullish on $avxl. Potential huge returns in 2025!

[u/biotek_squeeze → u/biotek_squeeze]

To expand further, another overlooked misunderstood fact is the difference/need of something with blarcamesine’s profile for Europe, vs the difficulties presented by the recently approved MABs. Many parts of Europe don’t have the infrastructure or money needed for the MAB treatments which require infusion centers, regularly scheduled MRIs to monitor for brain bleeds, and costs at least double (maybe more) than the simple once daily oral pill, blarcamesine.

There is also a difference in guidance for AD trials/treatments between the FDA and EMA. The old FDA guidance called for both the cognitive and functional endpoints to be used as primary endpoints. Recently (but not yet officially) the fda removed the ADL requirement for early AD as it is not able to discern the subtle changes in early AD patients. AVXL did not reach stat sig for this endpoint (of note: they did over a longer duration, for their OLE) to circle back, the EMA guidance was not as rigid as the fda, and when they EMA actually looked over AVXL data in the pre submission process they told AVXL to file for full Marketing Authorization instead of the conditional MA that AVXL inquired about. That paired with the fact that AVXL had European trial sites (and Australian) instead of USA sites (mostly due to cost, they chose EMA over FDA for the first application.

This is entirely logical and smart given the facts surrounding both agencies and their guidance and preference for an AD treatment.

Don’t listen to folks spouting off about “skipping the fda is a red flag”. It’s absolutely not, AVXL choosing the EMA was the most logical, intelligent decision for the company. Those saying otherwise are entitled idiots thinking the USA is the only place that matters.

The markets are actually the same size.

Once avxl secures European approval, the FDA would look like incompetent bozos to snub their nose at this safe effective treatment.

[u/Potential_Release478]

Well, its not a small list of researchers putting their name behind AVXL.

See today’s announcement.