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More and more research coming our way.
https://flip.it/fzE7mW ER stress and UPR in Alzheimer’s disease: mechanisms, pathogenesis, treatments
1950 welcome. Personally I do not believe when Rett is approved that you’ll see a lot of off label use. First off I believe the pricing will be out of whack for 99% of the people out there. If Dr. Missling holds true with his pricing for the Rett indication I suspect at 150,000 to 250,000 will price most people out of using this for Alzheimer’s off label.
Blackrock Vanguard and geode capital all increased their position this pass quarter. Blackrock is now up to 5.354 million shares Vanguard is up to 3.986 million shares and geode capital is up to 1.312 million shares
The answer is he is not interested in playing Wall Street games. He does not need to raise money and everything he says no matter how positive they beat the stock up. Call it accumulation. He does know where the stock is going and that is much higher. When that is maybe on p3 Alzheimer’s data. Maybe on partnership signing. Maybe when Wall Street gets their fill. Then they will run it.
Did anyone else see another potential revenue stream when Dr. Missling stated that they were putting together a diagnostic test to evaluate what patients have the wild type gene versus the non-wild type. That to me goes perfectly hand-in-hand with the precision medicine concept. if you are a 60 year old and want to get ahead of the curve to see if you can handle the 30 mg dose with max efficacy vs the non wild type who will need all 50mg. Or if you are a 40 year old who is looking at 273 as preventative having this test completed might be great to see what dose you will need. .
Enough product completed in manufacturing for Rett rollout??? Did I hear that right?
He was never part of Anavex. Never an employee.
Maybe just maybe he is getting his advice from the FDA and not the message board. He knows much more than we do and where we stand with all trials. I have faith in what he is doing and what he’s accomplished to date. Time will tell whether or not we have the goods but all indications are we do. If we have to wait for a partnership or approval for the stock to move then so be it. I’ve waited seven years I’ll wait another six months to 12 months.
Casavva
Phase 3 Program - Over 400 Patients Are Now Enrolled in Our Phase 3 Clinical Studies.
Open-label Study – Results of an Interim Analysis on the First 100 Patients Who Have Completed at Least 12 Months of Open-label Treatment with Simufilam Follow:
Drug Appears Safe and Well Tolerated.
Overall ADAS-Cog11 Scores Improved an Average of 1.5 Points (S.D. ± 6.6; P<0.05)
63% of the 100 Patients Showed an Improvement in ADAS-Cog11 Scores, and This Group of Patients Improved an Average of 5.6 Points (S.D. ± 3.8).
An Additional 21% of the 100 Patients Declined Less Than 5 Points on ADAS-Cog11, and This Group of Patients Declined an Average of 2.7 Points (S.D. ± 1.4).
Cognition Maintenance Study - Completion of Patient Enrollment is Expected Q4 2022.
Financial Results - Net Loss for Q2 2022 Was $19.3 Million, or $0.48 Per Share.
Cash Position - $197.2 Million of Cash and Cash Equivalents at June 30, 2022.
I never said that they will be purchasing $20 shares for the billion dollars. I said 1 billion down and buying Say 10M shares at $20. The $1b has nothing to do with the shares. The $1B is for the rights to market the drug.
Personally I think we are being held down due to partnership discussions with multiple parties not one. They all want a deal at cheaper levels. I believe all of this clears up with in a few months certainly after Alzheimer state is released. I believe a partnership could look something like $1 billion upfront ,purchasing our shares at say $20 per share and the stock will immediately rocket to $50 to 100
Bs. They will have all they need when they partner. Minimum $1B up front.
I would think that even the Aussie’s would want to see p3 before approval. Then if good it will be a race to see who approves first. I think it’s Australia then USA.
Not sure if this was mentioned but a few more new hires:
https://www.linkedin.com/in/janusz-debowski/ Dir. Analytical Development
https://www.linkedin.com/in/timahargreaves/
Time to get loud is when they actually give us the phase 3 results for Alzheimer’s not before. I believe that’s when the world will know what we have and they will be quietly shouting from the rooftops in true Anavex fashion. I do not believe we will have TV interviews and such but more subdued shouting like conferences, KOL’s talking, a true investor day, etc. and the hiring will be in hyper drive. That is all that they need. Oh yeah a big partnership with a billion $$$ up front.
If you could please explain this because that chart makes no sense to me. Thanks
As long as the company does not need to raise $$$ they don’t really care about the pps. They know what they have and their targets will be hit when the big news comes. So whether it’s 8 or 18 now means nothing. It just feels better at 18.
123 Tom how do you account for a coordinated short attack with charts? It seems to me that charting goes out the window when you have this kind of bullshit going on within a stock.
AF He is at it again. A tag team approach.
$ACAD said tonight that its marketing application for trofinetide in Rhett Syndrome has been submitted to the FDA.
acadia.com/media/news-rel…
Which is a good reminder that $AVXL promise to do same has... not happened. Failed studies are tough to submit to the FDA.
Everybody should remember that these girls are typically not communicating many of them are out of it and especially at this age many of them don’t last. Now I’m not saying that’s because of 273 but 273 certainly is giving this girl a personality and seems to be responding much better to communication. That in itself is a miracle
Wow She is on 2-73
https://stocktwits.com/kspar1/message/472123440
New hire.
Michelle Robinson Moran
On LinkedIn. Sr. VP level
I totally believe that they will get the data out in Q3 and with the hiring of marketing and sales people per the open positions on their website I believe we will start a major marketing push in q4 to tell the world what we have.
I have a feeling that these guys are going to get this Alzheimer’s trial data out in Q3 not Q4. All they need is top line data and not the full data set. I think that is very doable knowing that the trial ended in June. Three months is plenty of time for top line data. And they might be trying to get it done at the one or two Alzheimer’s conferences that will be coming up in the coming months
How do you know that they are not covered calls?
140k block went off just now.
She is in her mid-70s I believe. I think we could find some new blood with similar qualifications. Not to rag on old people since I am one myself
Who gives a f. Let George do his thing. He provides more value with the 50% of his posts that gets us some great data. The other 50% take with a grain of salt but he adds value.
And I wouldn’t be surprised that after accelerated approval by the fda the phase 4 will be in the United States.
NEW JOB POSTING
Director/Senior Director, Global Pharmacovigilance
About the job
Summary of Position
Anavex Life Sciences Corp. is seeking a talented and highly motivated pharmacovigilance director/Sr. director to join our team. This position will have full responsibility for Drug Safety activities for assigned projects in clinical trials. This includes meeting internal and external sponsor requirements according to time, quality, scope, and budget parameters. The Pharmacovigilance director is the primary point of contact for Drug Safety on a project, for internal project team members, sponsors, investigators, and vendors. This role encompasses the coordination of a variety of Drug Safety activities such as the collection, detection, assessment, monitoring, and prevention of adverse events and effects with pharmaceutical products. The role requires a careful and precision-based mindset that looks ahead to predict and prevent safety problems before they occur in clinical trials and other pharmaceutical related projects.
Key Responsibilities
Act as the both the Global Pharmacovigilance director and key contact point for regulatory authorities on PV related issues
Build GPV leadership team to set up, select and onboard PV vendor/CRO and maintain an efficient PV system in compliance with national regulations
Track and report any regulatory authorities or business changes impacting pharmacovigilance and support the development and implementation of procedures
Serve as a key liaison between the Global Clinical Team and third-party vendors for the management of adverse event reports from company sponsored clinical studies.
Lead safety operations activities related to clinical trials, and closely interact with Research & Development stakeholders to ensure an appropriate safety monitoring of clinical trials subjects
Work in collaboration Global Clinical Operations to maintain the pharmacovigilance section of the Trial Master File/Sponsor Oversight Files to ensure sections related to clinical safety are accurate and up to date
Lead the creation and review of important PV documents such as DSUR, IB updates, Annual Safety reports
Drive and support activities related to company sponsored clinical trials to provide required pharmacovigilance contributions such the drafting of Safety Management Plan (SMP), and the review of protocols, inform consent forms (ICF), and other clinical documents as required
Lead Global Pharmacovigilance and work with Global Clinical Operations, Regulatory Affairs, and Clinical Research Organization to ensure a timely submission of pharmacovigilance reports (SUSARs, DSURs, REMS, and other safety communications, etc.) to regulatory authorities and IRBs/ECs
Represent pharmacovigilance at a variety of business meetings, including project team meeting, vendor evaluation meetings, vendor oversight meetings, and other ad hoc meetings as assigned. Support audit/regulatory inspections and work closely with GPV leadership in the implementation and management of CAPAs following the audits/inspections
Ensure direct reports training records are up to date, including SOPs and yearly Pharmacovigilance refresher training
Responsible for receipt, timely forwarding, collection, and follow-up of individual case safety reports (ICSRs) as well as monthly reconciliation activities including maintenance of local site file/trackers when required
Provide the needed support in the scheduling compilation and timely submissions of Periodic Adverse Drug Experience Reports (PADERS) and other aggregate safety reports to the FDA and EMA
Have oversight of other programs like non-interventional studies, safety studies and local registries and websites
Provide relevant information as needed for the compilation of the Pharmacovigilance Master File (PSMF)
Support the development and maintenance of Safety Data Exchange Agreements
Represent the US site in discussion of safety operation issues at global functional team meetings
Help in generating and tracking KPIs in monitoring site/regional compliance.
Ensure appropriate filing and archiving of Pharmacovigilance related documents is performed
Requirements
Registered Nurse (BSN, MSN), relevant Master with previous PV experience, Pharmacists (RPh or PharmD), or Medical Doctor (MD, DO)
5 to 10 years’ related experience in a biotechnology or pharmaceutical company or CRO environment
5 to 8 years’ experience in Pharmacovigilance and quality assurance - tactical, operational and strategic capacities is preferred
Strong experience in the conduct and management of clinical trials, especially phase II and phase III clinical trials (CNS experience preferred but not mandatory)
Personnel management and supervisory experience is required
Excellent verbal and written communication skills, proof reading and organization skills
Comprehensive and working knowledge of Microsoft Outlook, Microsoft WORD, Excel and PowerPoint. Electronic document management experience a plus
Ability to handle sensitive material in a confidential manner
Strong attention to detail and follow-up skills
Maintain a high level of diplomacy, discretion, maturity and sound judgement
Must be flexible and willing to take on significant administrative responsibilities
Must take initiative and have ability to work independently and as a team member, and helping wherever needed
Must be able to create contingency plans to deal with possible challenges and roadblocks
Remote position; intermittently required to work on-site in New York City; occasional travel.
Apology accepted. I wrote my reply before you wrote your apology.
The difference is he has 10 years to fork over his $500,000 and he’ll end up doing a cashless exchange which actually cost him nothing basically. So let me splain to you this doesn’t show up as an insider purchase on any website that tracks insider buys and sells. It shows up as an option‘s grant. How’s that for splain’in. Try less hostility next time please.
Why would you expect that. No insiders have bought a share since Missling did his 215 share purchases years and years ago. If they ever did in any serious amount the stock would be driven much higher by retail which piss off the institution’s. And the doc certainly does not want that to happen. They are still loading up.
Unless of course you are thinking dr Missling getting his 500k options grant for the Alzheimer’s trial being completed. That certainly is not a insider purchase.
I see on the Anavex website where you can apply for a job in the drop-down box there are now 14 positions and I’m just wondering if anybody remembers what that look like a couple of months ago. I don’t think it was quite 14 and I’m not sure if some of the ones that were on there have been taken off because they filled those positions. I see they have the vice president of marketing and a director of sales position available I don’t remember seeing the director of sales position there before.
This does not suggest good news in the a.m. It suggests that their options have been granted and now they all have a lot more shares and they did yesterday. Hopefully there is news tomorrow but I would not equate that to this. As a matter fact I would venture to guess news is several weeks out because who wants to make it look like they filled their pockets and then released earth shattering news that’s gonna drive the stock up.
The big guys continue to add.
https://fintel.io/so/us/avxl
How about top line data early August.
https://aaic.alz.org/overview.asp
Am I mistaken here but did they change the pipeline chart just to say phase 3 for the Alzheimer’s trial. I wonder if they have approval from the FDA now that Alzheimer’s will be considered pivotal and should be considered a phase 3. Not a potentially pivotal p2/3.
It seems to me that maybe they couldn’t get the crowd they wanted so they decided to go to Plan B and do this video. I know I remember seeing another biotech or large Pharma I can’t remember which that scheduled an RD day today as well. I wonder if there was just too many conflicts and they decided to put it out this way instead of having a formal meeting with questions and answers.
Where is my call in number for the r & d day ? Where is my PR? Where is the “more information closer to the 21st”? Maybe 8:00am PR to capture a larger number of eyeballs for a huge announcement? Holy cow Missling missing!! Wtf??!!