Replies to post #326386 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Thank you for an exceptional post of not only "best in class" content research but also rewarding process insights. Just excellent stuff here Mayo,,,best I can recall.

I would add my own single observation.

Dr.M. recently stated during our open qrtly. discussion period that he expects the upcoming read out-reporting process to include evidence for the VALIDATION of AVXL MOA claims. Very powerful stuff with CNS disease consequences we can only imagine at this point.

[mike_dotcom]

And yet the great PDD news we did get drove the stock price down over 30%. What's wrong with this picture?

[Investor2014]

Mayo, for what it is worth I agree with you on this.

“It is likely Anavex anticipated full data to be finished by the end of 2nd quarter 2021; however, genomic sequencing probably surprised the company who’s now fashioning this intelligence into a robust data package for regulators. The company may have also deemed it valuable to wait to encompass 48-week OLE data as well.”

Inv2014.

[Bourbon_on_my_cornflakes]

MIND BLOWING ANALYSIS: Where is the PDD Data?

Dazzling work. Dr. M has always said the critical competence of AVXL was its ability to run tests, get the most out of them. MAYO you certainly laid out how this works.

Overcoming misdiagnosis in CNS - not a small issue, and one critical to accurate results.

Picking up potential effectiveness against other diseases - Lewy Body dementia ( and maybe unmentioned diseases such as cardio, glaucoma, etc.)

Documenting other benefits of treatment - better sleep

Dr. M laying the groundwork for a general CNS treatment approval!

[hudsonhog]

Phenomenal post. Very much appreciated, Mayo.

[XenaLives]

Impressive, comprehensive... thank you.

[boi568]

I have been a bit skeptical of the conclusion that Anavex is planning a CNS-wide prevention trial rather than just an AD prevention trial, but I am coming around.

The July 29 press release, which announced the preventative preclinical results for AD, used this subhead: "Anavex planning a Phase 3 prevention trial including participants at risk for cognitive and functional decline related to Alzheimer's disease." The text below does not go beyond an AD discussion. The key clue is in the subhead's use of "including participants at risk" for AD. This commits to planning for an AD prevention trial, but does not exclude the possibility of a broader trial that simply "includes" AD prevention.

Unfortunately, the most recent Motley Fool CC transcript discussion is not well recorded. The best that can be said is that Missling gave a generally affirmative response when asked to "speculate on which population the use of Blarcamesine as a protective might be most relevant from a clinical perspective."

So what I take from this is that Anavex has enough to go forward with a Phase 3 AD prevention trial, and has not ruled out/is actively working toward a broader CNS prevention trial. The scope of that broader effort may not be yet well defined.

All this is very impressive. The idea that Anavex may have an effective AD treatment drug in 2-73 would be an unbelievable breakthrough. The possibility that Anavex may have an effective AD prophylactic in 2-73 is a quantum step beyond. And the thought that 2-73 may be prophylactic across numerous -- or even all -- CNS diseases beggars the imagination. None of this is proven, but the fact that Missling has set his sights on such a far horizon is truly amazing, and admirable. I don't think the broader market has a clue what is going on here.

[RedShoulder]

Mayo, many thanks for your very detailed analysis of where we are currently with PD and PDD.

Your contribution and analysis to this iHub board and the stocktwits is invaluable.

[tredenwater2]

Remarkable tie together Mayo. No hand sitting here. Every trial is likecometing a floor on a new high rise building. The difference between our building and other baby Pharma’s (even larger pharma’s too) is that our foundation was designed to handle many more “floors”!

Great to be on board while we wait to see more of the “tip of the iceberg”.

[Boopka]

Mayo, thank you for taking the time to do a thorough analysis and to share your thoughts with the board. Your generosity is greatly appreciated. GLTA

[raja48185]

Thanks for the post.

Nicely presented and looking forward to developments in AVXL's PDD-related news/data.

[xodcode]

Thanks Mayo. Much food for thought.

[end2war]

Mayo,

Thank you for what I think is an excellent post interpreting the PDD data.

Your post focused me on the topline data from the 2020 CTAD presentation which I had not seen before.

That CTAD presentation is much better and more clear than was found in the PR of that PDD information, which left me somewhat confused. Your note makes it even more clear to understand.

Everyone should review this to fully understand the PDD case we have and the data that shortly is going to be presented.

[MayoMobile]

Those looking for possible PDD delay reasoning, allow me to reference this post for explanation.

[HMB2010]

Thank You!

[Pipilongstocking]

Thanks, good post.

[frrol]

Anavex is hypothesizing that these CNS indications can in many, and perhaps even most, patient cases share some fundamental common causes or factors, and that using intense data analysis with AI tools they can be elucidated and patients can then be characterized as treatment 'groups'. The hope for us is that we can then figure out who would be helped with our S1 agonists, and to what extent. Such predictive ability would be valuable for future trials, and then commercially. These AI efforts are the "sizzle" of our trials. The "steak" of course is the efficacy results. (Sizzle is irrelevant for gristle.)

[xodcode]

Mayo - Can't help thinking that TGD is well appreciated at high levels for AVXL's novel approach to CNS disease.

Probably has much to do with his acceptance/inclusion in Lausanne VIII.

Patience all!

Perhaps AVXL is verging on something HUGE!

Just got that feelin'!

[RedShoulder]

Thanks Mayo for the outstanding DD.

[jimmy_mcyoloswag]

Sticky?

[mrplmer]

Wow. Great deep dive Mayo. Thank you for your work and thoughts on this.

[Fireman02360]

[Summary: The way that Anavex has been processing data is cutting edge and unprecedented in the CNS space./quote]

This is one of the main reasons I own 10s of 1000s of shares. Anavex is "breaking the mold" in CNS, and I expect nothing other than generational wealth to be unlocked sometime in the next 2-3 years. Opportunity's like this come around only once in a great while. I am happy than myself, and many others on this board, were able to take advantage in the low single digits. Even @ $21, this is a absolute gold-mine, and if I had to guess, even 500 shares 10 years could make someone very wealthy.

Good DD Mayo, and thanks for sharing


-Fireman