Anavex Life Sciences Corporation (AVXL) 옵션

No urn is good Ern and A2-73!

The EMA and Rapporteurs can't know what they may not have been told.

So yes I clicked up the following website. https://deathsandfunerals.com.au/
I put in 2017 to present date. I put in Ern Heaven, Then I started over with Ernest Heaven and then one more Margaret Heaven.
The Sort that comes up shows all slight variations of the names you put into the sort. So it takes quite a while to get through a single sort of all the possibilities.

I got ZERO hits on any of the above three names. And yes I let it run on ALL of the AU States. It looks like both Ern and Margaret Heaven are still with us.
There is one other video but for some reason it would not come up. It started with the TV reporter and showed not only bits on Ern but also other of the Strong Responders. Perhaps someone should ask Dr Stephen MacFarlane how many survivors of the Anavex test back in 2015?

John k9uwa

william, that AI response is not accurate. Here, right from the EMA website:

"The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application."

Here is the link: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step

I’m not sure what to think of these guideline passages. To think the rapporteurs would ignore subsequent germane information strikes me as indifferent willful ignorance. It is hard to reconcile that with the responsibility of their task. If people started dying from a delayed reaction of blarcamesine they could not consider it as it was not in the submitted data package. Ironically it is what occurred with the mabs. Perhaps they are more rigid in the process than I think , we will see. As always thanks

Should that include a thorough review of the current administration's likely trading with insider knowledge?

Nice post. As mostly everyone thought. All trading activity should be audited and investigated in this security for past 7 years. In fact all trading companies should go through periodic trading audits Only way to keep the system honest. imo

Boom

gOeCK on Stock Twits-
“ Considering our route and the activities. If e act applies for Anavex CM is a real genius.
"Congressman Roy said: "Waiting for a pencil-pusher in Washington to green-light medications that are already approved in other trusted countries is the epitome of the bureaucratic nightmare that has plagued our healthcare system. This bill would cut through a wall of red tape that separates Americans from getting the care that they need, which means prioritizing their healthcare freedom."
Senator Cruz said: "Washington bureaucracy and regulations far too often interfere with the healthcare decisions of patients and their doctors. The RESULT Act will facilitate access to life-saving drugs, devices, and medical treatments that are already proven safe and effective in other trusted countries, empowering patients to access the medications they need to improve their health. I'm proud to be advancing it, and call upon my colleagues to expeditious take it up and pass it."

Happy Holy Week Tred. 

“Since the Sponsor is currently in regulatory submission stage of oral blarcamesine for Alzheimer's disease these documents need to stay proprietary and confidential. Market Authorization Application (MAA) was submitted to EMA in November 2024 and the full submission was accepted in December 2024 by EMA. Submissions to other jurisdictions are following.”

https://www.sciencedirect.com/science/article/pii/S2274580725000809?dgcid=raven_sd_aip_email

I am very encouraged by this strong rebuttal by Dr. Sabbagh. You cannot let your detractors dictate the narrative. I love the push back from him.

Maybe things are changing!

MUST READ Rebuttal letter from Dr Sabbagh

https://www.sciencedirect.com/science/article/pii/S2274580725000809?dgcid=raven_sd_aip_email

Thanks Scott Wanstedt on FB!

My question would be....was the highlighted portion the AI answer
or what appears editorial the entire post?

Doubting AI put quotes around "working days"

I wish they were engaged enough to know the proper name of our marvelous drug!

I take it then NONE of your posts are used to educate a major model?
Add suggested user skills and I guess you don't benefit from AI development.

“ Blacamazine Potential: May be used prophylactically due to its easy administration.”

This is what they have been going for all along imo. This is the iceberg that we have been seeing the tip of. This is “the front end is taking a bit of time but the back end will be swift” (paraphrased) and the infamous ,”when you see what we did you will understand why we did it the way we did” line.

Building out a CNS behemouth in real time and……in plain sight. Love it!

Happy Holy Week to all!

Tred

I'm not here often

Who is Ern Heaven?

Thanks in advance

Reading this document: Joint HMA/EMA multistakeholder workshop report on submission predictability and
this one: Frequency and Variation of Clock-Stop During EMA Assessment for Oncology Products – Implication on JCA Timelines

I can only add things up when the EMA approval process is defined by calendar days, regardless of terms used like "Active Days" and "Working Days".

The first document includes these paragraphs, where the bold one implies that Anavex should have submitted all data to be evaluated by the CHMP Rapporteurs and team of experts. There is no room for interjecting new exciting information say such as the Collagen Gene responder correlations or OLE data and results that may not originally have been submitted. An incomplete data submission will likely lead to rejection. Let's hope the submission was complete and sufficient!

The LoQ at day 120 should be responded within 3 months and the LoOI should be responded to within 1 month. Applicants may request an additional period of up to 3-month at day 120 and 1-month for providing their responses. The request should be duly justified by using the existing form and it will be reviewed and agreed by the CHMP. The CHMP is applying the strict principles on clock-stop as outlined in the CHMP guidance from 20091. Hence, when preparing the MAA, applicants should plan to have a maximum of a 3-month clock-stop at day 120- and a 1-month clock-stop at day 180.

Applicants should avoid the submission of an initial MAA with interim data knowing it may not be sufficient to reach a positive opinion, with the expectation to complement with full data following prolonged clock-stops. If an intended submission date is not met, a discussion should be initiated with EMA to assure the availability of assessment teams and explore the need for an adjustment of the submission date if warranted.

Ern Heaven is alive and well and taking blarcamesine each and every day.

GOD bless,

Yes and I think Ern may be in a super position of dead and a live.

I am fairly certain that you meant to post about Large Language Models LLM rather than LMM.

AI is only as good as the information available to the AI software.

Ern Heaven is still alive well.

GOD bless,

Oh so you also get messages and calls from hedge funds all the time offering you a dollar or two for writing stuff here.

Amazing way of Ern’ing or Urn’ ing beer money, although my mom says I shouldn’t spend the money on stupid stuff and instead save it for college or more MAGA hats.

While no official, verifiable announcement by Anavex has been found regarding the personal status of this trial patient, several independent investor and discussion posts consistently state that “Ern Heaven is confirmed to be deceased.”

Wow. It looks like Georgie needs to step up his game!

On Monday, 07 April 2025, Anavex Life Sciences (NASDAQ: AVXL) presented at the 24th Annual Needham Virtual Healthcare Conference. The company showcased its advancements in oral small molecules for neurological disorders, particularly Alzheimer's disease. The conference highlighted Anavex's regulatory progress, financial health, and strategic plans, balancing optimism with the challenges of entering competitive markets.

https://wsw.com/webcast/needham146/register.aspx?conf=needham146&page=avxl&url=https://wsw.com/webcast/needham146/avxl/2275487

Good luck and GOD bless,

As could be expected an LMM is only as good or bad as the information available and highly dependent on the prompt.

"Please thoroughly investigate whether “Ern Heaven”, once an Anavex trial Alzheimer’s patient who appeared to improve, is still alive or may be dead. Include references used."

"Below is a summary of what we know about “Ern Heaven” and the available information regarding his current status, based on published investor posts, discussion forum posts, and publicly available press releases from Anavex Life Sciences and related news sources.




Background




“Ern Heaven” was mentioned several years ago in online discussion forums and videos in connection with Anavex Life Sciences’ early clinical trials for Alzheimer’s disease using their lead compound (blarcamesine, also known as ANAVEX®2-73). In these early trials a handful of patients were reported to show stabilization or even improvements in some clinical measures. “Ern Heaven” was one of the individuals whose case was discussed in such forums, and his improvement was noted in various informal accounts and investor/commentary posts.




Investigation of His Current Status











Overall Assessment




Based on the available discussion threads on investor websites and online forums (with numerous mentions by community members claiming that “Ern Heaven is confirmed to be deceased”) and in the absence of any official update contradicting these claims, the balance of publicly available evidence seems to lean toward the conclusion that “Ern Heaven” is no longer living. However, because clinical trial subject details are generally kept confidential and because public company releases focus on aggregate data rather than patient-level outcomes, independent confirmation (for example, in a peer-reviewed study or an official obituary) is not available.




References




• Anavex Life Sciences press releases and investor updates (for example, the GlobeNewswire release on April 05, 2025, detailing long-term trial results) 


• Investor discussion posts on platforms such as InvestorsHub and Seeking Alpha where users discuss “Ern Heaven” and comment on his status (e.g. BIOChecker4’s post stating he is “confirmed to be deceased”)  , 


• Alzforum’s summary of blarcamesine and related clinical trial data 




Conclusion




While no official, verifiable announcement by Anavex has been found regarding the personal status of this trial patient, several independent investor and discussion posts consistently state that “Ern Heaven is confirmed to be deceased.” In the absence of any contradictory official update, this appears to be the consensus in the online community.


Please note: Information gathered from online forums and investor discussions represents informal sources; without an official confirmation from a reliable public record (such as an obituary or direct company statement), there is some degree of uncertainty."

"Anavex Life Sciences at Needham Conference: Strategic Insights on Neurological Innovations"

Investing.com
https://www.investing.com/news/transcripts/anavex-life-sciences-at-needham-conference-strategic-insights-on-neurological-innovations-93CH-3972316

On Monday, 07 April 2025, Anavex Life Sciences (NASDAQ: AVXL) presented at the 24th Annual Needham Virtual Healthcare Conference. The company showcased its advancements in oral small molecules for neurological disorders, particularly Alzheimer's disease. The conference highlighted Anavex's regulatory progress, financial health, and strategic plans, balancing optimism with the challenges of entering competitive markets.

Key Takeaways
- Anavex is progressing with regulatory submissions for blacamazine in Australia and Europe.
- The company boasts a strong financial position with $120.8 million in cash and no debt.
- Promising clinical trial data shows blacamazine's potential in reducing brain atrophy in Alzheimer's patients.
- Upcoming milestones include Phase 2 trial data for ANAVEX3-71 in schizophrenia and new studies in Parkinson's disease.
- Anavex aims to expand its CNS indications and explore disease prevention applications.

Financial Results
- Cash Position: $120.8 million as of the last quarter
- Debt: None
- Operational Expenditures: $30.8 million last year
- Cash Runway: Approximately four years based on current cash and expenditure
- Funding Sources: Includes non-dilutive funding from the Michael J. Fox Foundation

Operational Updates
- Regulatory Submissions: Blacamazine submissions accepted by the EMA, with further discussions planned for other regions.
- Clinical Trials: Data from the Phase 2/3 Alzheimer's study and ANAVEX3-71 schizophrenia trial expected soon.
- New Studies: Planned initiation of studies in Parkinson's disease, Fragile X syndrome, and another rare disease.
- Rett Syndrome: Real-world evidence supports long-term benefits of blacamazine.

Future Outlook
- Blacamazine Potential: May be used prophylactically due to its easy administration.
- CNS Indication Expansion: Exploring new applications and disease prevention.
- Publications: Additional research expected on blacamazine, ANAVEX2-73, and ANAVEX3-71.

Full transcript - 24th Annual Needham Virtual Healthcare Conference: (see link above for full transcript)

Hmmm - did you read the last paragraph?
In general also a reminder that a LMM has no idea or understanding of any topic and can be made to serve different answers even by a very slight change to the phrasing of a prompt.
So far AI is but a tool handy for doing stuff, but only as good or accurate as its user's skills.

The following confirms that there are more participants from the Phase 2a trial than just Ern Heaven that are still taking blarcamesine daily after 9 years.

“…some participants are on oral blarcamesine once daily for over 9 years….”

Notice that Ern Heaven's wife is Margaret Heaven (see the news story below at about 1:42 minutes into the video).



Good luck and GOD bless,

The Margaret identified by name and picture in the video and the Margaret identified by name and picture in the obituary are the same person. What’s more, the obituary refers to her husband, Ern, who is listed as “dec”, meaning deceased. Whether Ern has an obituary or not, he is the same Ern who was married to Margaret. Ern died sometime before his wife. That is an established fact.

Knowingly telling a lie about a dead man in order to promote the stock for selfish purposes is disrespectful and shameful.

And I’ll say again, the video of Ern proves nothing. Ern could have had a spontaneous if short-term recovery. My father had AD and briefly experienced something similar. We were surprised and hopeful that the change would be permanent but it was not to be. We also don’t know if Ern was receiving some sort of supportive care and/or another medication that may have been helpful.

No drug regulator is going to make a judgment based on one guy in a video. Likewise, investors should to view the video with interest but also a healthy dose of skepticism.

I believe the EMA will ask Anavex to conduct large Phase 3 trials because the data presented at the conference a week ago were hardly confirmatory.

My reading of the data is that there was some evidence of a slowing of cognitive decline (not a reversal of cognitive decline) in a subset of early stage AD patients, but that was about it. In my opinion, the data will not support a broad approval, or perhaps any approval, by the EMA.

Real important stuff discussed today on the board bashers fudsters and shorters, not to mention a video that I've seen a hundred times and talk all over the board about a guy thousands and thousands of miles away that is probably dead or maybe he's not what is the difference.... boy you talk about useless word salads

No Ern Heaven death reported.

https://deathsandfunerals.com.au/

couldn't we just ask chat or one of those other supes about Ern?

Hmm per my ChatGPT question: Does the EMA Timeline use calendar days
ChatGPT said:

Yes, the EMA timelines are based on calendar days, not business days, unless otherwise stated.

This applies to most regulatory procedures, including:

Marketing Authorisation Applications (MAA): The standard evaluation timeline (e.g. 210 days) is in calendar days.

Scientific Advice, Orphan Designation, and Variations also follow calendar day timelines.

Clock stops (when the applicant responds to questions) are also typically in calendar days.

So, when you're planning submissions or tracking milestones, always count weekends and holidays unless EMA specifically says "working days."

https://deathsandfunerals.com.au/

Update on a daily chart.

https://investorshub.advfn.com/uimage/uploads/2025/4/11/wlqtsScreen_Shot_2025-04-11_at_3.03.05_PM.png

I'm not sure you have a point. Maybe that there aren't hedge funds involved in the super high number of shares short?

Per ChatGPT.
📅 What Are "Working Days" in EMA Timelines?
🔹 Definition of a Working Day:
In EMA context, a working day is:
Monday through Friday, excluding EU public holidays and EMA closure days.
Weekends (Saturday/Sunday) are not counted.

➡️ So when the EMA says it takes 210 "active" or "working" days, this does not include:
Clock stops (the time the company spends preparing responses)
Weekends
Holidays

This means a "210-day" process in EMA terms can take 12–18 calendar months depending on the length of the clock stops and complexity of the review.

The bashers, FUDsters, and shorters began to paint the tape for AVXL stock at 3:25 today.

GOD bless,

I just write what a hedge fund tells me Take a breath, boi. Feet on the ground.

Ah I thought that is what I said. After Anavex has sent all requested information then the clock starts again. They then have 60 days to CS2. during that 60 days the Rapporteurs will meet with CHMP And yes it is possible if CHMP had additional questions they will ask. The 30 days they make decision. Total of 210 days. Only PLUS to the 210 days being length of time it takes Anavex to get requested into during CS1. Maybe with some luck there won't be any delay at CS1. If by chance
ZERO delays ruling would come down around July 25th.

yes another 100K plus MOC

John k9uwa

So what is the correct interpretation for working days?

However maybe Ern Heaven has an unlisted number so that he is not interrupted while playing golf or out jogging? We know that many have been benefiting safely from blarcamesine for over four years and some (Australians!) for over nine years! Aussies are a tough breed!

You weren't. Just another classic frrol post, leaping before looking and refusing to admit error.

How you were wrong is a good question.

You are "correcting" him by just repeating what he wrote about clock management.

Yes. If there's any future update on the company's MAA progress it would most likely come from mentions during quarterly CC's between now and end of year, during Q&A. Any proactive update depends on Missling.

And how was I wrong on working days?

Would you care to post the correct answer or just say I'm wrong?

Others might want to see your wisdom.

The clock restarts once the company submits its response to the RFI/LOQ. Biotech, not fantasy. Your "working days" claim was also incorrect, I think you're seeing that now. Folks should not be misled.

I don't believe you are correct.

The clock starts again when the company relies to the RFI given to the company at the beginning of the clock stop. As I understand it, it is then that the CHMP evaluates the responses while the clock is running. There is a second clock stop later if there are additional questions.