rayovac812
18分前
The peer review gives us confidence as investors, everyone including doubters need to consider that.
That is certainly one aspect of assurance. The most favorable early on, is the restoration of brain loss volume to levels of healthy individuals. That was all the assurance I needed with a high level of certainty, that news beyond would be good news. Of course it is the collective data that puts it all together, but that one there meant the news after the blanks get filled in, was going to be all good. It enabled what I think will be a correct early call.
dia76ca
22分前
ChatGPT ranks safety of Kisunla , Leqembi , and Blarcamesine .
Kisunla :
(ARIA): In clinical trials, 25% of patients experienced ARIA-H microhemorrhage, 24% had ARIA-E, and 15% had ARIA-H superficial siderosis.
Infusion-Related : 9% of patients reported reactions, with 43% of these being moderate or severe. 13% of patients discontinued treatment, primarily due to infusion-related reactions.
Leqembi :
(ARIA): 20% of patients experienced ARIA, with 15% developing ARIA-H (brain bleeds) and 11% ARIA-E (brain swelling).
Infusion-Related : Approximately 28% of patients had reactions, with 43% of these being moderate or severe.
Blarcamesine :
25% of patients experienced dizziness in early trials, with a reduced frequency of 9.6% in subsequent studies after adjusting titration schedule.
Most adverse events were mild or moderate.
Blarcamesine has the most favorable safety profile, with mild side effects. Leqembi and Kisunla have incidences of ARIA and infusion-related reactions.
georgejjl
39分前
From the latest press release:
"...some participants are on oral blarcamesine once daily for over 9 years. Importantly, no severe or life-threatening adverse events were attributed to blarcamesine...."
https://www.anavex.com/post/anavex-life-sciences-announces-positive-up-to-4-years-oral-blarcamesine-results-from-phase-iib-iii-o
Below is on of a few participants with Alzheimer's disease who have been taking an oral blarcamesine capsule each and every day for 9 years.
*****************************************************************
An Australian TV news interview of Ern Heaven and his wife. Ern had Alzheimer's for over 2 years and was declining when he joined the Anavex phase 2a trial of Anavex 2-73. Over a period of a year on the drug, he first stabilized, and then improved. No other drug has ever helped an Alzheimer's patient improve.
According to the 1 year trial results, 6 patients out of the initial 32 had "strong" reactions and showed improvements in one or more tests.
Good luck and GOD bless,
catdaddy
54分前
Grok did pretty well here, Lakeshore!
"Oh, how delightful for you—blessed by Augustinians, Jesuits, and the occasional stroke of serendipity, no less! It’s truly a tragedy that the rest of us mere mortals haven’t been granted such a refined education in the art of distillation and grand planning. I’m sure we’re all just wallowing in our unmentored misery, clutching our juvenile angst like a security blanket while you ascend to loftier planes of existence. And how generous of you to offer us a spot in your queue—on your schedule, naturally. I’ll just be over here, trembling with anticipation for your next masterful move, while my so-called peers scribble their scorecards. Do carry on; the stage is yours."
tschussmann1
1時間前
Hoskuld, I have copied below the beginning of today's email from George Friedman: Geopolitical Futures. I am not a Trump fan, nor I suspect is he, but what he writes explains what is happening. Change is coming: the prior system has not been in the US interests for a while, though it was during the Cold War era. Trump is accelerating the change, as did Covid before. The entirety of George's writing is worth a read.
"There are two analytic principles worth repeating before delving into the raft of tariffs the Trump administration issued last week. The first is that we have entered into an unanchored world order, a state in which one geopolitical era transitions to the next. All things that were certain in the past have become uncertain – the storm before the calm that I applied to U.S. politics.
The second is the distinction between geopolitical imperatives and geopolitical engineering. Geopolitical imperatives force nations to act in certain (and predictable) ways. Geopolitical engineering is how nations manage their geopolitical imperatives, a process that requires balancing a nation’s domestic politics between those who welcome the new reality and those who oppose it. The outcome is predictable, even if the process by which it emerges is less so, apart from the outcome dictated by geopolitical reality.
With that in mind, the current geopolitical reality is this: The world order that had been in place throughout the 20th century has eroded, and a new era is being engineered. We are in a period in which the norms of the past century are no longer relevant. It is an infrequent and unsettling time, but throughout human history, this has been a normal abnormality."
Investor2014
2時間前
I also asked, especially for Guzzi of course, to evaluate my post replied to:
This post is markedly more measured, informed, and constructive than the previous one. It acknowledges uncertainty, emphasizes the importance of data transparency, and reflects a sound understanding of the regulatory review process. Let’s evaluate it section by section:
🧠 “Fortunately Anavex haven't as far as we know failed with EMA yet. Hope they don't and pass clock stop one.”
✅ Accurate and measured.
Correct: Anavex has not failed with the EMA — the MAA was accepted in December 2024.
Clock Stop One is indeed a critical stage where the EMA may issue a List of Questions (LoQ), and the sponsor must respond to continue the review.
The phrase “hope they pass” reflects the uncertainty inherent in biotech, without making exaggerated claims.
📊 “The key here remains that we have not seen the data and detailed analysis methods as applied by Anavex to the data.”
✅ Very fair and important.
One of the biggest concerns among analysts and investors is that Anavex has released topline claims without publishing full peer-reviewed data.
This limits the ability for independent validation and rigorous scrutiny of trial design, statistical methods, and data handling protocols.
🔍 “Understand too, that nor have the peer reviewers, who review the consistency of what is written in the article.”
✅ Correct and insightful.
Peer reviewers assess whether the study methods and conclusions align, but they do not have access to raw data unless specifically requested.
This highlights that publication ? full validation in the way that regulatory review does.
🧾 “The regulatory agency have all the data available and will request as needed that which may not be included, so that they can see if the results claimed can be replicated.”
✅ Spot-on explanation.
The EMA and FDA receive full clinical study reports (CSRs), statistical analysis plans (SAPs), and often raw datasets.
Their role is to replicate or audit the conclusions, often requesting sensitivity analyses, subgroup breakdowns, or alternative statistical models to confirm robustness.
This level of scrutiny is far beyond a journal article.
💡 “This is important to understand for biotech investors.”
✅ Completely true.
Biotech investors often overweight press releases and headlines without understanding that:
Regulatory agencies dig much deeper.
Lack of full data transparency can amplify uncertainty and risk.
Even a statistically significant result might not meet the regulatory threshold for clinical relevance or risk-benefit ratio.
⚖️ Overall Assessment
Element Assessment
Tone ✅ Balanced, rational, constructive
Scientific understanding ✅ Reflects correct trial/regulatory norms
Investor value ✅ Educational, encourages due diligence
Bias ⚖️ Mild optimism, but not promotional
Usefulness ✅ High — especially for newer biotech investors
🧭 Summary
This is a thoughtful and valuable post. It doesn’t speculate recklessly on outcomes but instead educates on:
The importance of full data access
The limits of public-facing summaries
The rigor of regulatory review versus publication
The realities biotech investors must consider
If you're evaluating sentiment or gathering viewpoints for due diligence, this post belongs in the “informed caution” category, as opposed to the emotional or speculative extremes that can dominate biotech discussion boards.
Investor2014
2時間前
I asked ChatGPT to evaluate your post, I suppose you might be partially happy with its findings:
This post about **Anavex Life Sciences (AVXL)** and its Alzheimer's drug candidate **blarcamesine (ANAVEX®2-73)** is clearly an **opinion piece** — highly **skeptical**, even **cynical**, with a **short bias**. It raises some **valid points** but also makes **sweeping conclusions** that may not be fully supported by the available data or the regulatory process. Let's break it down analytically and objectively:
---
## 🔍 **Key Claim-by-Claim Analysis**
---
### 🧠 “*‘Significantly improved clinical decline’ — That’s ‘Missling speak’ for early stage patients got worse more slowly*.”
- **Accuracy**: ✔️ Technically accurate. In Alzheimer’s trials, “slowing of clinical decline” **does not mean reversal or improvement**, but rather a **statistically significant reduction in the rate of worsening**. This is the **standard measure** used by all major Alzheimer’s trials, including those for Leqembi and Aduhelm.
- **Framing**: The phrase “Missling speak” is **derisive**. While Anavex’s CEO Christopher Missling is known for optimistic language, **“slowed decline” is standard regulatory and scientific terminology**.
---
### 🚫 “*Blarcamesine is not the miracle drug that will change medicine forever… Its utility is limited to early stage AD patients who are extremely difficult to diagnose*.”
- **Partially Fair**: Blarcamesine has shown **potential efficacy in early-stage Alzheimer's**, which is **the same patient population targeted by Leqembi and donanemab**.
- **However**: That doesn’t equate to it being **“useless for the majority”** — rather, **most Alzheimer’s drugs are focused on early intervention**, and the **difficulty of diagnosis is a known, systemic challenge**, not unique to Anavex.
---
### 💊 “*No pharma company is going to partner with Anavex based on the reported data.*”
- **Speculative**: There’s **no way to definitively know** this. Partnership decisions depend on:
- **Regulatory feedback** (e.g., if the EMA grants approval, the calculus changes dramatically).
- **Mechanism of action** — blarcamesine targets **sigma-1**, not amyloid, making it a **diversification** bet.
- **Long-term safety profile**, oral administration, and **pipeline overlap** with neurodegenerative targets.
> Some big pharma **have partnered on weaker data** — if the market need is high and differentiation exists.
---
### 📉 “*Likelihood of EMA approval is extremely low… regulators want large, years-long Phase 3 trials.*”
- **Overstated**: EMA **already accepted the MAA** in December 2024. That doesn’t guarantee approval, but it means they believe the dossier was **sufficiently complete for evaluation**.
- The EMA may **reject**, **conditionally approve**, or **request more data** — all are realistic outcomes. But claiming an “extremely low” chance **ignores the possibility** that:
- The EMA may approve it **with post-marketing obligations (Phase IV)**.
- The **safety profile** (no ARIA) may be seen favorably given recent **Kisunla rejection**.
---
### 🩺 “*Shorts can rest easy.*”
- **Highly biased**: This is a subjective investment opinion, not a data-driven insight.
- **Biotech is volatile**: Shorting a company with an active EMA filing and a novel MoA always carries **binary risk**. If EMA approves, this position could be punished severely.
---
### 💰 “*Missling will continue in his role… collect more millions… while the stock languishes.*”
- **Fair criticism of governance?** Maybe — some investors have concerns about Anavex’s **communication style**, **lack of partnerships**, and **trial design opacity**.
- But this is **heavily emotional language**, not objective analysis. It appeals to frustration common in retail-heavy biotech stories.
---
## ⚖️ **Overall Value and Correctness**
| Element | Assessment |
|-------------------------------|--------------------------------------------|
| **Facts about trial terminology** | ✔️ Generally accurate |
| **Criticism of trial scope** | ⚠️ Partially valid, but exaggerated |
| **Partnership assertions** | ❌ Speculative and unverifiable |
| **Regulatory outlook** | ⚠️ One-sided, lacks nuance |
| **Tone and objectivity** | ❌ Highly biased, rhetorical, dismissive |
---
## 🧭 **Balanced Conclusion**
- **This post is not factually wrong**, but it's **heavily biased**, pessimistic, and uses **emotionally charged language** rather than nuanced analysis.
- There is **a reasonable bear case** to be made about Anavex (limited dataset, single pivotal trial, small company infrastructure), but also **a reasonable bull case** (novel MoA, strong safety profile, oral drug, MAA under review).
- Ultimately, **the EMA’s decision — and potentially the FDA’s — will determine the outcome**, and both sides are making educated bets.
Would you like a side-by-side risk/benefit matrix or a model of different approval scenarios for Anavex?
BIOChecker4
2時間前
“significantly improved clinical decline”
That’s “Missling speak” for early stage patients got worse more slowly.
Based on the reported data from Saturday, Blarcamesine is not the miracle drug that will change medicine forever as the WGTers believe. Its utility is limited to early stage AD patients who are extremely difficult to diagnose. It clearly does nothing for the vast majority of AD patients. By the way, no pharma company is going to partner with Anavex based on the reported data.
I think the likelihood of EMA approval is extremely low. Regulators are going to want large, years-long Phase 3 trials and unequivocal data showing a much bigger benefit in a much wider group of AD patients before any possible approval.
Shorting AVXL has always been an easy decision. After reviewing the data from Saturday’s presentation, I think shorts can rest easy.
Here’s the scenario I see coming: Sometime this year or early next year, the EMA turns down Blarcamesine and tells the company to go do large phase 3 trials. The stock will tank, but hopeful (dare I stay delusional) retail investors will side with Missling, blame the cabal (as usual), and just accept that a few more years of Phase 3 trials and dilution will be needed in order to finally achieve the riches they dream of. Retail will pour dry powder into the stock and brag about what a great deal they’re getting. (Sound familiar?) While the stock languishes in the $2s, Missling will continue in his role as a one-man band and collect more millions in salary, benefits, and cheap stock options.
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WolfofMia
48分前
