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SEARING TRUTH in their face. To all - Please consider sharing this Fierce biotech editorial far and wide - with anyone who might have an interest in Alz like family, friends and even your family physicians. Most people would not have exposure to this information on a new medication and knowing of the issues might help them make a more informed decision in a dismal situation.
At least his action will draw more attention to the issues at hand.
Agree!
I feel for the patients and families that may not know how to research a new drug. They are desperate for help for this disease. It would be interesting to ask the reps as they push it when it comes on the market about the panels recommendations and why it was ignored. The doctors prescribing it probably can’t imagine this is possible. It is very worrisome.
The FDA may not enjoy the scrutiny their decision may bring to their doorstep. Especially if there is a problem with side effects. Not sure if this has been posted.
https://www.statnews.com/2021/06/08/fda-expert-panel-resigns-alzheimers-approval/
Pre split here too, remember the excitement at Nasdaq listing. Even then it was obvious the current AD drugs were not working. I have watched a lot of people suffer with this miserable disease.
Godspeed AVXL !!
The Major Leagues ( BIBBI, LILLY, etc ) consider Anavex a farm team at best and would like to keep them on the farm except to maybe skim the cream of the crop. But it is spring training and everyone is getting a look at the bench. This is a complex game and a long season, we, the fans can only watch.
ICYMI;
Alzheimer's Association Denies Conflict in Aducanumab Support
March 8, 2021
The Alzheimer's Association is denying accusations by two researchers in the field and a watchdog group that its repeated endorsement of aducanumab, a drug under US Food and Drug Administration (FDA) review for the treatment of Alzheimer's disease (AD), has been unduly influenced by financial support from the two companies seeking approval, Biogen and Eisai.
In response to a request from Medscape Medical News, the Alzheimer's Association disclosed that it has received at least $1.4 million from Biogen and Eisai since fiscal year 2018 (FY18).
Mike Greicius, MD, MPH, associate professor of neurology at Stanford University's Wu Tsai Neurosciences Institute, Stanford, California, who has received research support from the Alzheimer's Association and is at the center of a dispute with the organization's affiliated journal, Alzheimer's and Dementia, says the association did not disclose financial backing from the two companies in an October letter to the FDA supporting the drug's approval or in a January 29 note to supporters and staff when the FDA delayed the approval decision.
Greicius is one of three authors of an opinion piece on aducanumab in Alzheimer's and Dementia. That article concluded that the drug is not effective and should not receive FDA approval.
Leslie Norins, MD, PhD, CEO of Alzheimer's Germ Quest, a Naples, Florida–based company that funds research into a potentially infectious cause for AD, has also said that the association has failed to properly and fully disclose these potential conflicts.
Accusations about the Alzheimer's Association's lack of disclosure are the latest development in a string of controversies and setbacks surrounding aducanumab — including the Alzheimer's and Dementia journal dustup.
"Baseless, Entirely False" Speculation
Greicius was one of three authors recently disciplined for what editor-in-chief Ara Khachaturian, MD, said was a failure to disclose a potentially relevant conflict. However, Griecius believes the journal retaliated because the Alzheimer's Association did not like the article's conclusion.
Maria Carillo, PhD, the Alzheimer's Association's chief science officer, told Medscape Medical News that the journal is editorially independent and that she would not comment on Khachaturian's action. Carillo also said she has not had any communication with Khachaturian about the article.
Alzheimer's Association spokesperson Kate Meyer told Medscape Medical News that "speculation that the association had any role in actions by the journal is just that, speculation, baseless and entirely false."
Meyer noted that one of Greicius' coauthors, David Knopman, MD, told Stat that he did "not believe the Alzheimer's Association has engaged in retaliation in this matter."
When asked by Medscape Medical News to weigh in, Knopman and coauthor David T. Jones, MD, said in a joint statement, "The comments attributed to us as reported in Stat are accurate."
Page 2 of 4
Greicius said he, Knopman, and Jones decided to write the opinion piece about aducanumab because they were concerned that Biogen was promoting it primarily through press releases and investors, not in scientific venues, where it would be vetted on the basis of evidence.
They approached Khachaturian about writing an opinion piece, and he agreed, said Greicius. The article was accepted in early October. On October 27, Jones allegedly tweeted a screen shot of an uncorrected galley proof.
Carillo, who saw the tweet, said she tweeted at Jones (whom she knows) to remove the tweet because the article was embargoed. Jones quickly deleted his tweet. A day later, he tweeted to someone who was asking to see more of the article, "Apparently it is embargoed. This was news to me as I thought it was not."
As it turns out, the article was not embargoed, as Carillo acknowledged, saying her terminology was incorrect. She said she had merely wanted to alert Jones that a galley proof should not be made public.
The article was published November 2, but not before Khachaturian determined that Knopman had a "relevant conflict of interest" that he had not disclosed in the manuscript ? namely, his membership on the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. Knopman agreed to add the language, which now appears in the article.
Knopman also did not disclose that he is a member of the Alzheimer's Association's Medical and Scientific Advisory Committee (MSAC). When asked by Medscape Medical News whether he should have mentioned the MSAC membership, he declined to comment.
"Incredibly Costly, Resource-Devouring"
Khachaturian said the lack of disclosure about the MSAC position was not important. He noted that the journal publishes "the names of all MSAC members on the journal's masthead, every month."
Sometime after the article's publication on December 28, Khachaturian wrote to the three authors, informing them that tweeting the galley proof was a copyright breach and an "ethical violation."
In addition, he wrote that Knopman's failure to disclose his FDA advisory committee membership, which he had been forced to recuse for the aducanumab meeting, was another ethical breach.
Khachaturian wrote that such breaches "cannot be ignored" and told the authors that any new submission during the next 2 years must be accompanied by a certification from their institutions that they made proper disclosures. The email was also sent to Carillo, the authors' department chairs, and other academic superiors.
Greicius was infuriated. He emailed Khachaturian, saying that Jones' tweet "strikes me more as a simple misunderstanding rather than an ethical breach 'that cannot be ignored.' " He called the editor's action a "heavy-handed sanction."
The journal must have been pressured by the Alzheimer's Association "to punish us for the opinion piece that ran directly counter to the Alzheimer's Association's letter of support to the FDA," wrote Greicius.
Knopman and Jones, however, told Medscape that the association had "acted within their obligations."
Khachaturian defended his action, telling Medscape, "the editors have a responsibility to protect the integrity of the journal as a reputable forum." The journal sought advice from "colleagues in academic publishing, our publisher (Wiley), and the Council on Publication Ethics (COPE)" before taking action.
Ten journal editors found that the authors erred in distributing an uncorrected galley proof, he said.
"We ultimately took a path that we believed addressed this serious matter while enabling the authors to continue to publish important future articles in the journal," Khachaturian said.
Knopman and Jones said they "look forward to furthering Mayo Clinic's strong working relationship with the Alzheimer's Association."
Page 3 of 4
However, Greicius said he is not likely to submit to the journal again and that he knows he may have damaged his ability to receive future funding. He said he's not against the organization. "I'm very grateful for their public advocacy efforts," he said.
However, he believes the association is "kind of shooting themselves in the foot and hampering the progress they set the stage for by pushing so aggressively to get this, in my view, useless medication ? incredibly costly, resource-devouring medication — approved."
Call for Candor
Neither Knopman or Jones addressed the issue of whether the Alzheimer's Association might have a conflict regarding its support of aducanumab.
Carillo says the association has been forthcoming about the financial support it has received from Biogen, Eisai, and other drug and device makers. "Anybody can find it at any time" on the association's website, Carillo said.
That's not an acceptable answer, said Greicius, who noted that when he submits a paper, he discloses his ownership of shares in SBGneuro.
"It's with the paper. You don't have to go to my personal website and try and figure out where my conflicts are listed," said Greicius. "It has to be with the text that people are reading so that they can understand it in that context."
Michael Carome, MD, director of Public Citizen's Health Research Group, told Medscape Medical News he believes the Alzheimer's Association is "biased because they get funding from industry.
"Too often there are patient advocacy groups that take significant funding from industry groups, and that money either consciously or subconsciously influences the positions they take," Carome added.
Through multiple press releases, Norins has called on the association to be more candid.
"The standard is not whether it's mentioned somewhere else in the world but whether you reveal right at that moment that there is a potential conflict of interest," said Norins. "I totally reject this tap dance the association is doing," he said, referring to the claim that the Alzheimer's Association is transparent because sponsored support is listed on its website.
Alzheimer's Germ Quest accepts no outside support. It is entirely funded by Norins, who was previously a medical publisher. He is also the publisher of MCI911.org, a website that aggregates news about mild cognitive impairment and offers tips for prevention through exercise, nutrition, and supplements.
Although it's true the Alzheimer's Association does not hide its industry backing, it is not easy to clearly delineate and aggregate the support. Many companies have given money to the association, although it appears that Biogen and Eisai have been among the largest, if not the largest, donors over the past few years.
The association discloses on its website the total support that it has received over the past 5 years from drug, biotech, and device makers. The information is on a landing page about its corporate partners.
Industry Support
Since fiscal 2016, about 1% of the association's $300 or so million in annual revenue has been supplied by industry. The organization also lists corporate donors in broad categories of dollar amounts in its annual report.
Individual drug company contributions for fiscal year 2020 are featured on a separate web page, but contributions for other years are no longer publicly available.
Data provided by the Alzheimer's Association show that in FY19, Biogen and Eisai were the number one and three contributors among drug company donors, pledging $380,380 and $361,250, respectively.
Page 4 of 4
Data available on the association website show that in FY20, Eisai pledged $250,000 and Biogen pledged $200,000. In comparison, Eli Lilly and Genentech gave slightly higher amounts — just over $300,000 — and Merck pledged $855,000. Merck discontinued trials of its verubecestat for Alzheimer's in 2018 and does not currently have any Alzheimer's therapies in its pipeline.
Both Biogen and Eisai are "platinum sponsors" of the upcoming 2021 Alzheimer's Association International Conference, which requires a $200,000 donation. Biogen was also a platinum sponsor in 2018, 2019, and 2020. Eisai was a platinum sponsor in 2019 and 2020.
Acadia Pharmaceuticals, Eli Lilly, and Grifols are gold sponsors, contributing $100,000, and AbbVie, Boehringer Ingelheim, and Janssen/Johnson & Johnson paid $50,000 each and are silver sponsors.
Meyer provided the sponsorship amounts to Medscape Medical News upon request. The sponsorship dollar amounts are not listed on the Alzheimer's Association's website but are included in the overall annual report, which gives figures the organization makes public, Meyer said.
In 2020, the association launched a new conference ? Neuroscience Next ? which was held virtually in November. Biogen was a gold sponsor, donating $25,000, according to Meyer. No other companies were listed as sponsors.
Biogen is also a "sustainer" of the association's political action committee (PAC), Alzheimer's Impact Movement. For that role, companies contribute $25,000 annually.
A Rocky Road
The Alzheimer's Association also reports that just two other drugmakers, Amgen and Lundbeck, were sustainers in FY20. The PAC contributions are not included in the overall donation tally to the Alzheimer's Association, because that PAC is separate, and the disclosure rules are different for PACs, said Meyer.
Aducanumab has had a rocky road to get to where it is now — it is in a holding pattern awaiting final word from the FDA. As reported by Medscape Medical News, the agency postponed the approval date by 3 months — from March to June – on January 29.
The FDA granted aducanumab priority review in August, in part because it would be the first-ever disease-modifying treatment for AD.
The agency worked closely with Biogen to ensure a smoother course — a collaboration that has drawn criticism, in particular from Public Citizen. In December, the group asked the Department of Health and Human Services' Office of the Inspector General (IG) to investigate. The IG acknowledged the letter but did not say whether it would proceed.
On November 6, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended against approval, citing a lack of effectiveness. Only 1 of 11 members voted in favor; eight voted no, and two were uncertain.
Carillo, the Alzheimer's Association chief science officer, said that despite the panel's doubts, the organization was encouraged by the FDA staff's positive review of the data. The association supports approval as long as Biogen is also required to conduct a phase 4 postmarketing study, she said.
"We as an organization have to weigh the crushing realities that individuals and their families face when living with Alzheimer's," said Carillo. She noted that the association believes the publicly released data tilt in favor of the drug's effectiveness. Given the lack of a therapy that would even slow progression, "for us, approval is justified," she added.
Carrillo would not say whether the Alzheimer's Association had sought the counsel of its medical and scientific advisory group.
Flimsy Evidence?
Another advocacy group, US Against Alzheimer's, has also endorsed aducanumab. It also receives funding from Biogen and Eisai, although the companies are only listed as "donors" in the organization's most recent annual report.
US Against Alzheimer's had revenue of $8.4 million in 2019; $8.1 million came from contributions and grants from foundations, individuals, corporations, and drugmakers.
The FDA should be commended for its work with Biogen, said US Against Alzheimer's CEO George Vradenburg and neurologist Jeffrey Cummings, MD — a Biogen consultant — in a February 8 opinion piece in Stat.
"This partnership was not only appropriate but is expected by the FDA as defined in its recommended best practices for communication," they write.
Aducanumab may not be a breakthrough, but it could represent incremental improvement, which in itself is important, they note.
Carome disagreed. Noting that his mother died after 10 years of living with Alzheimer's, he said, "I understand the desperation and the desire to find treatments that really work." But, he added, if aducanumab is approved with what he characterized as "flimsy evidence," it could potentially bankrupt Medicare, given that the drug is projected to cost $50,000 a year.
Barron's reports that Wall Street analysts estimate that aducanumab could generate $10 billion a year in sales.
Giving aducanumab a green light "could ultimately delay finding treatments that actually do work and give false hope to millions of patients and their families," said Carome.
All The Best Anavex Team !!!
Sure, he did not make any comments on results but he has over 1000 followers and likely in the field or closely related neuro fields.
George Perry? @geoperry Oct 14
Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease Patients;
Dr Perry mentioned Anaxex results in a tweet 2 days ago.
Good exposure from a leader in the clinical field.
Never know what may happen.... or what doors may open.
From Bioworld: "Rodin lands $27M financing to advance #alzheimers program but without exclusive $BIIB deal, said to be terminated by mutual accord"
Maybe cash is being reserved for other deals???
The apple would be some investigative reporter at the WSJ
Maybe you could give 60 Minutes a heads up?
Like your sound reasoning and keeping focused on what the data has shown so far. For the patients I wish it had been a clear reversal. However, I am cautious in regard to;
It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive more than impressive.
31 weeks is not enough time to confirm a true stabilization of disease given that the symptoms of Alzheimer's disease worsen over time, although the rate at which the disease progresses varies. Life expectancy varies for each person with Alzheimer’s disease . The average life expectancy after diagnosis is eight to 10 years. In some cases, however, it can be as short as three years or as long as 20 years.
All the possibilities of efficacy in other indications will hopefully lift this and many patients up. Not to mention the pipeline.
It is so hard to wait when the clock is ticking for a loved one.
Long $AVXL
I have learned a lot from your post, thanks.
With approval for any indication, I believe there would be immediate off-label use, and not just for ALZ. However, the FDA would likely view any effects as anecdotal observations without more trial data. Approval in other markets would probably be helpful as well. Drug approval is an arduous process.
IMO all of these pre-clinical findings are very exciting. FTD would be a great avenue to a FAST TRACK approval, ther is absolutely nothing to treat it with now. This class of compounds may change the whole neuro field in a way that is unimaginable. So many diseases with only paltry treatments....
This company has so much potential it is impossible to articulate. Missling and the team are busy on many fronts,other than following SEC requirement etc I doubt they are paying much attention to the daily pps changes. If the anavex drugs continue to show benefit there is no stopping this company. We are here for the roller coaster and it is exciting.
Still no abstract posted......intrigue.
Are any board members attending?
Thank you for a very balanced overview. I, like others, am very new to investing and bought in to AVXL when it was in the 50 to 80 cent range. It is clearly a unique approach to this devastating disease and while none of us want to lose $ most of all I hope this early data holds strong and the drugs work! Never having been in a stock that was manipulated and shorted I was taken to school for holding long. Waiting for data has made this a very poignant stock lesson. I have also learned that every turn of events ( or lack of ) is sensationalized on the board. Reading in between the lines of every PR or move Missling makes has created so many rumors. I greatly appreciate the experience and opinion of other who can help make sense of the timeline, events and technical developments. I have been around clinical and pharm research for years but never considered investing until the last couple of years. JMHO but I suspect Anavex and BP are not strangers and this company is being watched closely. Only the company knows what negations have and are ongoing but this seems to be moving along nicely. If significant benefit is demonstrated with upcoming data releases patients and stock holders will have a lot to smile about.
Godspeed $AVXL !!!
Reasoning and common sense very helpful in all walks of life / good post / thanks
I agree, logic suggest there would be a limited improvement in the PLUS component since we know what the typical impact is of donepezil alone. Correct me if I am wrong but it slows progression in some, delays institutional placement but can't reverse the damage/ or on going damage because it is only affecting acetylcholine concentration, not the underlying cause (which is not truly understood). There are many examples of drugs having a synergistic effect and there may be some positive effect of a PLUS regime in some patients but the study is probably too small and brief to sort it out. IMO AVXL is focusing on establishing efficacy, safety and ultimately approval. Clearly a successful treatment is needed early in development of the disease, just look at the PET images of AD brains and it seems donepezil is like applying a bandage to a cut, damage often significant before any treatment attempt. I thought it would be much more difficult to get approval if Anavex 2-73 has to ride the shoulders of donepezil, JMO. Thanks for your thoughts.
Sounds positive and intentionally thought provoking without spelling everything out prior to the conference.
- identified lowest dose for theraputic effect
- saw some change across all doses
- no additional improvement in the plus arm so the patent is a non issue
- focusing on safety profile which will be a big question for a drug people will theoretically take for years ( takes the premature cure talk out of focus )
- ethically if you see benefit / how could one not offer continuation when there is nothing else out there?.
Akin to the concept of withholding insulin to a diabetic in its early days....
Looking forward to the presentation for more info ! JMO / Godspeed $AVXL
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Nice summary and for more info those interested can use google (or Google scholar if they really want in depth original articles) and search Mediterranean diet and alzheimer's.
For a lighter weight summary on one study check this
http://medicalxpress.com/news/2015-03-mind-diet-significantly-alzheimer-disease.html
Maybe you could ask for equal time....
Have her watch this ??
It seems a clearer picture of the company in how it functions and its structure would address a lot of the guessing. The Blue Book Update:
About Us for:
Hybrid Coating Technologies
Daly City, California 94015
(650) 491-3449 (310) 799-8499
Request a FREE Quote
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Company Information
Year Established:
2010
Labor Affiliation
Not Provided
LEED Experience:
Not Provided
BIM Experience:
Not Provided
Number of Employees:
10
The last 10Q showed 3 employees. Surely updating investors on such progress and employee roles would not infringe on any NDAs etc and would settle some of the jitters. ( it would for me) long HCTI! GLTA
My condolences, prayers for your family.
Fear not, for I am with you; be not dismayed, for I am your God; I will strengthen you; I will help you, I will uphold you with my righteous right hand.
Isaiah 41:10
Thanks for the post, will be saving that one!
No offense taken :)
I only stated statistics and gave an example of a very successful Pharma deal. I made no projections. The Alz numbers I gave are just US data not world wide and since only data on a small number of patients has been reported the outcome is impossible to predict. Also, indications are often expanded on drug use when efficacy deems it appropriate and experience with a compound grows. In medicine there is daily use of medications outside of the initial indications.
I just hope for the patients this is a Winner! I have family members with the disease and I found the company looking for new treatment on the horizon. The prospect is exciting and the investment is secondary.
Disease prevalence puts this in a new category.
Any thing close to 4X improvement over SOC is going to be mind boggling
Totally agree !!!
It seems you both are aware of the havoc these herbicides and GMO seed are creating.
Based on what I have read.... it is highly likely such compounds are playing a major roll in colony collapse in the honey bee population around the world. Just one example.
Here is some GREAT news:
http://www.rsc.org/chemistryworld/2015/10/monsanto-2600-job-cuts
Sorry for those who will lose a job but IMO this is monster company.
UNLIKE AVXL which has the potential to be positive on all levels. I have immediate family members with this disease, it is tragic in every way and they suffer daily.
Godspeed to AVXL!
They have us strapped in....
Nice set up for a RUN to the Moon ??
Bring it on !!!!!!
This is what I was trying to say:
http://www.investopedia.com/terms/c/capitalgainstreatment.asp
Hope that profit has us all figuring it out !!!
I was told If you own it over a year profit is taxed as Capital Gaines but less than a year as regular income. Your shares should have an order number that you can identify when you purchased and sold.
Betting on next Tue or Wed for news - but I hope it is this week!
HCTI record :
PR/News events
5 were on a Tuesday
7/14/15 by the EPA- award
4/7/15 1 by HCTI 1st mention of F500 deal
3 were in Sept to Nov 2014 and were teasers from a NY radio show
1 on a Wednesday
8/12/15 update F500
1 on thursday
X- EPA Chief Board appt
Monday would be a first
Got curious and looked back at all public news and SEC releases for HCTI that I could find and they go back to 8/19/14 ....
1) of 14 SEC filings 2 were on a Tuesday / 6 on a Wednesday / 4 on a Thursday / 2 on a Friday
2) of PR/News events 5 were on a Tuesday ( 7/14/15 by the EPA- award, on 4/7/15 1 by HCTI & 3 were in Sept to Nov 2014 and were teasers from a NY radio show) / 1 on a Wednesday ( 8/12/15 update F500) / 1 on thursday (X- EPA Chief Board appt )
This may not be enough data to mean anything but if History repeats itself - news will come in the middle of a week.
All The Best!
Wow, Dollar land would be an incredible place to be!!! Easy to see how the award would affect a co like SW but HCTI would be a true fairy tale .... the best part is we are all in the story. Life Is Good!
Clearly a wonderful time in your life!
This is the first sub penny I have ever invested in, so right now I feel blessed to have chosen this one. I have watched the board and am learning from you all. It seems everyone feels .10 is very likely in the near future. Would anyone care to speculate on EOY, 6 months from now, 1 year? I don't really know what is possible because everyone(until now) I ever heard talk about OTC had a very negative long term view. Thanks in advance !
There are more investors out here....
I missed this so in case others did as well:
NEW YORK, Aug. 12, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property (IP) protection until at least 2035. ANAVEX2-73 is the subject of an ongoing Phase 2a clinical trial for the treatment of Alzheimer’s disease.
The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.
“This patent is a valuable addition to our IP portfolio and covers innovations we have made in our development efforts for ANAVEX 2-73 and beyond,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We have filed numerous patent applications to cover promising compositions and therapies, including those pertaining to ANAVEX 2-73, in keeping with our commitment to a comprehensive IP protection strategy.”
Additional U.S. patent applications filed for pharmaceutical composition of matter for ANAVEX 2-73 will, if granted, provide further patent protection until at least 2035. An additional patent application on file for ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil, if granted, will provide protection for composition of matter until at least 2033.
The USPTO issues a Notice of Allowance after it determines that a patent should be granted for a claimed invention that is novel in comparison to all known technology in existence. Based on the timing of this Notice of Allowance, Anavex expects the patent to be issued by the end of 2015.