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The pre-clinical work by Dr Nilsson ref PRE-084 in 2015 appears to be a precursor to the current study of 2-73 described by the second article. That she would be involved now seems to be a distinct possibility since she is noted directly below that article.
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https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
Dr. Angela Nilsson is linked to Sigma-1 and Annex 2-73 on the MJFF website and could possibly conducting the short biological study of 2-73 in Parkinson's patients prior to P3 clinical trials.
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https://www.michaeljfox.org/researcher/m-angela-cenci-nilsson-md-phd
https://www.michaeljfox.org/grant/neurorestorative-effects-sigma-1-receptor-agonist-model-parkinsons-disease
Pharma is down today across the board....any apparent reason?
Have to watch my computer with its automatic spelling feature...trialing vs trailing! Should post in the morning when I'm fully awake!
You know is was talking about Anavex....to late at night.
What an amazing company Anaxex is, to have as many CNS diseases being trailed or planned across the globe... Australia...U.S./Canada...England ...EU. It has so many leading edge scientific balls in the air with such a relatively small but experienced staff. It's obviously inward looking as the extreme medical and business activity demands. The company's self absorption rubs some of us investors the wrong way as it attempts to get 2-73 and 3-71 to a needy world suffering from terrible scourges. Now I know that we are on the side of our brothers and sisters who have Alzheimer's Parkinson's, Rett Syndrome, Anglemans, Schizophrenia, Frontal Lobe Dementia and many other disorders, but it is going to require patience....so much for tonight's pep talk!
Trofinetide with its serious side effects will be a second option to Anavex 2-73 when approved and that will be sooner than you suppose. Nuplazid has some very serious Box Warnings and would appreciate proof of its sales record.
We may be second by a few months, but like Biogen/Eisai's drugs we will have a more effective drug with none of the debilitating side effects. The diarrhea and vomiting can be serious for young Rett girls...then there is the 17% dropout statistic.
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Most participants in the trofinetide group (92.5%) had a treatment-emergent adverse event, most commonly mild to moderate diarrhea or vomiting. Adverse events led to study withdrawal in 17.2% of the trofinetide-treated participants. In both groups, 3.2% of participants had serious treatment-emergent adverse events. There were no fatalities.
Nidan, we can't underestimate the role of large institutional investors putting their thumbs on the scales of pharma competition. I'm concerned about Blackrock(Larry Fink) who along with Vanguard is at the top of institutional investors. Blackrock is the 2nd largest holder of Biogen ( 14.3 mil shares, $3.6B and 9.9% of shares). It is also in the top 3 of holders of Lilly, Pfizer and Merck as well as other large Pharmas. Blackrock has a lot more invested in our competitors than in Anavex and I wouldn't put it past Fink to tip the scales. Here is a 2021 article on the subject of large institutional investors efforts in controlling the market.
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https://www.trtworld.com/magazine/who-owns-the-world-s-largest-pharmaceutical-companies-42983
Believe this could be happening presently as a precursor to the Parkinson's P2/3 trial.
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https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
You want proof of FDA and big Pharmas push for an revenue successful Alzheimers drug then look at "Fierce Pharmas" list of top 10 drug launches for 2023. Not only are they pushing Biogen/Eisai's Leqembi but also Lilly's Donanemab which has been fighting an up hill battle with the FDA until Leqembi lowered the bar. You can see why Dr Missling is carefully getting 2-73's data in line. What a shout/pushback from big Pharma (Biogen, Eisai and Lilly) will go up if/when the FDA approves the better data of Anavex. Standby for some fireworks!
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https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2023?utm_source=nwnurture&utm_medium=email&utm_campaign=ls-fp-nw-nurture-email1-trending&oly_enc_id=6344A1822112C6Z
Plex...since 2016, the same as you my friend.
Basparkes....2-73 will be the "Keytruda" of the CNS world!
Biogen's Aduhelm and Leqembi seem not be the Alzheimer's bockbusting drugs that they and the FDA hoped for. Anavex 2-73 is in the wings and should clear the low bar that has been set with ease!
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https://www.biospace.com/article/biogen-expects-modest-leqembi-revenue-as-aduhelm-takes-another-hit-/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=246195522&_hsenc=p2ANqtz-8iZgxVgG2rraKxToR3ALdJC8ACDTGmL5RBLsNIlClNYoe8HcnVVxBFoyIGIqw0mHUhJU8IgVxqvzkHo3YkCAPuGM_yfQ&utm_content=246195522&utm_source=hs_email
Tough sledding for our competitor (Lilly) with their amyloid drug.
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https://www.biospace.com/article/innovative-trial-design-may-have-cost-lilly-s-donanemab-accelerated-approval-/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=242813879&_hsenc=p2ANqtz--U7wSCsdH30mg4q-SJTz8kjCydpb9vh3UzMJT4tOz0WV8h2ijG8sruuNqZqs1jQQv39o0SVRbxAERT2yiZJj4fNEF34g&utm_content=242813879&utm_source=hs_email
This article talks around our MOA of the "small molecule" working across blood /brain barrier.
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https://www.biospace.com/article/recent-alzheimer-s-and-als-approvals-a-catalyst-for-the-neurodegenerative-space-/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=242373419&_hsenc=p2ANqtz-9a2yUAK0RiK_VUQjYCiaIMEopiOpejDQ7izTj_5QVbDNebrAaKRqw7lU-EUpmm6caK63lyLmLNzAT6thE6n7jpOZGJRg&utm_content=242373419&utm_source=hs_email
Tred....thanks for the pep talk. Sometimes we need to step back and evaluate our situation objectively....small biotech with less than 50 employees, four major drugs, 6 and maybe more trials at various stages in Australia, America, Canada, UK, Spain, Belgium, five major national/regional Health Agencies. The scope of Anavex's worldwide business activity relative to its size is amazing. Also, the impact of the company's drugs on the damage of CNS diseases will be immense. What is our role as investors...patience and support. Pray for a capable and constructive partner to move the process along. If your motive is as an investor is only $ ROI, maybe there are other companies that you'd better invest in. If you want your company/investment to lessen the suffering in this world....Stand Strong
Nidan....anyone with a brain would give a negative evaluation to the amyloid plaque approach, but the history of the Biogin/Eisai drug and its early failures, known dangers and its planned cost, defies reality. The FDA must see that, and it's decision will either increase or diminish it's credibility.
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https://www.biospace.com/article/biogen-s-rocky-2022-finish-sees-further-aduhelm-lecanemab-scrunity/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=240226799&_hsenc=p2ANqtz--KyyXHjm2YqPUaFM_rR1MRzh1Qk1_8zY0Qz1SfoBEPpRsui9jaRbYkkUTpfARv8uwm_SfoJ0zCCb5ksO68gtx7yTOBfQ&utm_content=240226799&utm_source=hs_email
There is a lot of foxhole talk with our backs against the dirt and our rifle between our knees......then the western sky lights up and and the great battle against disease begins!
Tough day on WS....the Bio's are down SAVA nearly $3.
A Joyous Christmas to all my fellow board members..... and remember the real REASON for the season. I know we all pray for the gift of healing that our drugs hold for the many that suffer and may it come soon for the little girls with Rett Syndrome and those grandparents who deal with dementia. Look forward to a challenging and rewarding New Year with all of you.
Talon
Lacey....Thanks for reminding of the big picture of our drug including Rett Syndrome which will be reported out in early 2023 and Parkinson's work with MJFF (see below). Our multi faceted drug in CNS is like Merck's Keytuda is to Oncology with its possible applications in dozens of diseases. The future is more than bright!
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https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
MKikesc......I think people fail to digest what the article by Jessica Wong in Forbes is speaking to with reference to Anavex's precision medicine approach to the 2-73 Alzheimer's Trial.
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"The use of AI and machine learning is transforming digital marketing in the same way that biopharma is. Algorithms are driving some of the leading B2C and B2B marketing channels. Data analysis is allowing marketers to make data-driven predictions rather than relying on historic results to make recommendations.
As with biopharma, digital marketing and advertising use data-driven technology. A programmatic advertising campaign, for example, is an effective means of building brand awareness and delivering relevant messaging at the right time. Through AI and machine learning, marketers can build models and personas and optimize campaigns with a wide variety of targeting capabilities that allow them to reach and scale toward niche audiences.
Another example is branding. Audiences associate a brand with tangible and intangible factors. Consistent, authentic branding—including for biopharmaceutical companies—can help build audience trust and establish long-term customer relationships. For instance, the data companies gain from using AI and machine learning for research can strengthen a brand’s credibility.
Plus, by focusing on how these technologies are changing the research process, digital marketers have an opportunity to demystify drug development and remove barriers between patients and biopharmaceutical leaders.
With all that said, we are only at the beginning of implementing AI and ML in both biopharma and digital marketing. As these technologies penetrate both industries further, they will open opportunities for and change the approaches of scientists, manufacturers and communicators alike."
McMagyar.....AMEN!
Talon
Georgejji.....certainly what I thought when I read this!
Fitzy....so sorry to doubt your superior knowledge on the content of specific CV's. And so very sorry not to check into your CV as a professional drug analyst. You have taught me a lesson as to your skill as a contributor to this board!
David Goldberger...what is very significant is his European experience with the EU drug regulatory world.
Biovie....who is in their IR office to get this publicity for a P2 Trial!!!
See Stuart Varvey's article about half way down in the Fox News articles.
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https://www.foxnews.com/
Autophagy......you have articulated the motives and hope of many longs. Thank you.
LSDD....thanks for providing your background as a long term investor. Your newness to the board and the present controversy over Anavex's TLD for Alzheimer's have us wary of recent comments/analysis by those who don't want the company sp to succeed. I know that all of us are concerned over the apparent shortcomings of the data. With two former FDA members who handled NDA's for many years within the company, my opinion is that Anavex is aware of how the data needs to be formulated. Given that the trial was multinational and there were complex CRO requirements in the midst of three years of COVID, it not surprising Anavex is struggling to galvanize those results timely. This board is rife with investors with technical backgrounds whose analysis's are very well meaning, but who are minus access to all the data. Like football spectators who have played the game, paid for their ticket and can see from an elevated position in the stands the receiver open down field....we don't have the arm of the 270 pound defensive end in our face as we look to get rid of the ball!
Have faith in our team and look for our drugs to alleviate suffering in millions of hopeful patients.
Looks like "LifescienceDD" has exited left....wonder why?
LifescienceDD...a bit of skepticism about your late advent to the board and your first three comments (1 Dr. Perry's voracity, (2 Trevelyan's defense and (3 The role of the doubter.
Additional questions are, (I Are you an investor? and (2 What is your background that underlays your analysis of this clinical trial of Anavex 2-73?
At this point, those who have been around as thoughtful investors are allowed to question motives when someone shows up at critical moment with detailed negative comments. Your well laid out arguments have a legal ring to them.....are you testing the water?
jav0033.....tone it down and watch your language, a comment on patience doesn't need to be profane and insult a Name which is precious to many of us!!
Tradeherpete....I was stationed in Hawaii for 6 years at CINCPAC and HQPACAF and many times stood on the Memorial over the Arizona and thought about the great sacrifice of those who lay below. As one of our brother's messages says....Freedom isn't free"...it is paid for by the courage and blood of many patriots then and now! Remember December 7th!
I concur with you Tradeherpete. We discussed the MTA ( which was about 2-73's ability to remyelinate nerves to treat MS) in 2018, Dr Lisak at Wayne State had provided preclinical evidence of 2-73 ability to remyelinate nurves. Since about 70% of Biogen's income at that time was from drugs that treated MS, it seemed like a good fit with Biogen. Unfortunately, the hang up was over Alzheimer's which Anavex's 2-73 and Biogen's Aducanumab were in competition to treat. As you mentioned it appeared that Biogen's offer for 2-73 or a buyout of Anavex was far too little for Chris Missling and the MTA was concuded with no agreement. As you pointed out Biogen's actions towards Anavex since that time have been aggressive bordering on hostile. The approval of 2-73 and/or lecanemab is "round 8 or 9 with Biogen and its friends in big Pharma trying to bury the little upstart Anavex. Will it happen...Biogen needs to rethink the outcome!!
So much for a hostile buyout and " candyland"
AVXL 2-73 got some press.....wouldn't you know that Biospace would give Anavex the "stumble" treatment while giving a questionable P2 most of the article. This is solid example of the establishment trying to paint our CTAD briefing in a negative way with a shove from AF....knew it was coming!
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https://www.biospace.com/article/ctad-taurx-touts-safety-and-efficacy-as-anavex-stumbles-over-potential-data-error/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=236662161&_hsenc=p2ANqtz-8ygicfe2bs-12eV1nwRdanwapckOjEjrF6FI1arfiYGdm1hc4mHa5eTw583drws97t7iPnK-2fWwoMvgVXeJigR_vM9g&utm_content=236662161&utm_source=hs_email
Power....after theFDA capitulation on Biogen's Aducanumab, Biogen and Eisai have figured they can use "brute force" to get Lecanemab approved. That with all the brain swelling and bleeding which has been documented in Clarity. On top of this is now the question of cognitive improvement. The consequence of all the bad evaluation of the Biogen drug has been that FDA will require additional scrutiny of all Alzheimer's drug candidates. even ours.
Partners may be lurking!
"Roche thins Alzheimer’s program after phase 3 failure, may seek ‘external partnerships’"
Fireman, Thank you and I am well and very happy for all those diligent members of the Anavex team for this outstanding trial and those still in progress. Hope you are well and maybe planning your financial independence. I presume the the high country fire season still has its exciting draw, but now you can choose the more manageable ones and not the "Dixie" types! My hat is off to you for your prowess in the market and on smoldering slopes.
Cheers and God Bless,
Talon
Tred.....meanwhile Eisai and Biogen are doing the "Manipulation Tango" at the CTAD.
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https://www.biospace.com/article/eisai-biogen-address-lecanemab-s-safety-concerns-at-ctad/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=236095705&_hsenc=p2ANqtz-_0qphM9xWjaLC9ekT0Kh7vFLpFyK43vFgMfAuW_A6kARmHAsOAMUKx7tLqP-s-9CrJr31qZ_aI0ZzMTmZ10D4OWk7taQ&utm_content=236095705&utm_source=hs_email