Replies to post #475836 on Anavex Life Sciences Corp (AVXL)

[catdaddy]

Thanks, Doc, but I believe I will go with this:

https://media.stocktwits-cdn.com/api/3/media/558354/default.jpg

[12x]

Always great insight Doc! I understand the company may be aiming for a headline like 'Best Blarcamesine cohort can halt AD progression', but I agree these findings are hypothesis-generating and could inadvertently impact the approval chances.

What’s your perspective on the seemingly promising OLE results hinted at by Dr. Sabbagh’s AD/PD 2025 oral presentation title: 'Phase IIB/III Attention-AD trial Over three years of continuous treatment with oral Blarcamesine continues to SIGNIFICANTLY BENEFIT early Alzheimer’s Disease patients'; While it doesn’t address dropout rates or safety, does it suggest that efficacy—at least based on ADAS-Cog13—is sustained over three years? This was one of my main concerns, especially given the delayed separation in efficacy until 48 weeks during the earlier trial phase.

[sab63090]

Above my head, so thanks for shaking the tree!

I have to rely on people like Dr. Sabbagh, Dr. Jin, and someone recently who made things happen with the MAA filing (Talavera) to be one step ahead of the negative comments I've read about such as:

"There will be no MAA filing before year end"
"no peer review paper"

Although the price has been stopped quite a few times below that $10 area, it continues to stay right below it without crashing; makes me think that the momentum up is just stalling for now.

Yes, there is a negative divergence currently with RSI/price..the reading can easily shift to very strong over +70 to over +80 on a quick volume/price push up!

[Hosai]

Can't definitely say there wouldn't be any other kind of trial but if there ever was hopefully it would be post approval.
The idea that the EMA would not at the very least give conditional approval (the benefits are greater than the risks) would be kind of absurd when they have approved Lecanumab which even in the sub-group approved had a weaker ADAS COG & CDR SB score vs placebo than Blarcamesine and worse risks in terms of safety (outside of the small risk of death from drug Lecanumab has been approved despite it not being clear yet why it seems to shrink the brain).
To say otherwise I would suggest someone has some kind of financial incentive in it taking a lot longer for patients to try Blarcamesine rather than having patients interests at heart.

The variant finding was very low p value - 0.0001 but doesn't necessarily mean much yet due to the sheer number of genes and variants looked at as it could be argued they may have been bound to stumble on one with that level of significance (sigma wt sub-group which showed improvement was obv pre-specified though). However the OLE looking positive (from title) is great news and clearly was seen as significant enough for Dr Sabbagh to do a 15 minutes presentation on it at the AP/PD summit.

[williamssc]

I noticed neither Mayo or Peter wasted their intellect on SAVA..