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George....sports application poses a great area of protective use for 2-73 and the SigmaR-1 property. TBI and CTE has been identified in the NFL as a long term danger for the players. Having played football and rugby in college when the shoulder was the point of contact and the unforgiveness of artificial turf wasn't a factor, there was significantly less brain injury. What is even more worrisome is the worldwide growth of soccer and youth soccer. "Headers" are taught and used at all levels and although individually infrequent in a game, they could be injurious over a life time of playing.
Certainly there is no wide spread alarm in sports/combat area of life, but it is there and will be an area for Anevex to address once the current disease focus has matured.
I'm listening.....hope the music is beautiful next week!!
Steady....you are right, the course of treatment is a factor, as I mention that the comparison is difficult because of the severity of the condition and the treatment schedule. Although, oncology varies quite a bit also.
Falconer....agree with your discussion of sleep application, but a drugs use/cost depends a great deal on whether it is considered the SOC in its application. As a sleep aid, 2-73 would be one of many while in Alzheimer's, Parkinson's, ALS or MS it may occupy the position of SOC. However, what might keep it there is its additional effect on sleep and the overall health of the body.
While we wait the pricing discussion continues...probably one of our top 3 topics. Much too complicated for our board: applications/number of diseases; insurance; length of treatment; competition/patent protection plus a number of other factors that our MBA is aware of. Below is a recent couple of posts that contains Merck's discussion of "Keytruda's", one of the worlds leading oncology drugs, pricing. Correlation may be discussed, but 2-73 and "Keytruda" may ultimately have similar wide use in number of diseases and patients.
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"A drugs worth question keeps poping up like a bobber on a sunny warm lake. The problem with AVXL 2-73 is its probable wide application in the CNS world. The comparable example is Merck's Keytruda which has the proven multiple applications alone and in combinations in the Oncology world. Here is that discussion again from last Feb.
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Worth....as the science starts to prove itself and topic of our discussion seems to gravitate towards what's all worth? .....to us - "worth the wait" - to those who suffer...."priceless". What will transpire will depend on a number of factors, how the science applies, how broad is the application (# of diseases), worldwide dist our drugs and competition. What is the assured will be benefit to "millions' and we will receive both the joy of helping others and monetary reward.
From a Jantuary post as to what Merck faces with "Keytruda".
"Steady.....the questions of what Anavex 2-73 might cost has been a constant topic on the board for some years. As discussed, it is very complicated due to the possibly large number of CNS diseases it might be effective in and the varying severity of those diseases. How would you differentiate price per dose between the sure death sentence of late Alzheimers and the dose for early Rett Syndrome. We've also dicussed the possible parallel between Merck's Keytruda and its many applications in oncology. Although, effective cancer treatments come at a premium, an effective drug for Alzheimers, Parkinson's, ALS and MS would push a drug's cost in that direction. Long term prophylactic use lies between critical disease use and an over the counter drug cost. But, then how do you justify the former with the latter?
From Keytuda's website:
"figuring out what you might pay out of pocket for a prescription medicine can be confusing. What you pay will depend on many factors, including your insurance situation and if there are financial support options available to you. At Merck, we believe that you should be better able to understand what you can expect to pay out of your own pocket for your prescription medicine.
The list price for each indicated dose of KEYTRUDA when given every 3 weeks is $9,869.94. The list price for each indicated dose of KEYTRUDA when given every 6 weeks is $19,739.88.* The total cost of KEYTRUDA over the course of treatment is the same, whether given every 3 weeks or every 6 weeks. Most people will not pay the list price, although it may have an impact on your out-of-pocket costs. The amount you pay will depend on many factors, including your insurance situation. The information below will help you better estimate what you may pay for your prescription medicine based on your insurance situation and also cover financial assistance that may be available to you.† For the actual out-of-pocket cost of your treatment, talk to your insurance provider, who knows the details of your plan if you have insurance, or contact your oncologist’s office for help."
BB.....the Brothers getten us altogether!!
Tradeherpete....here is another article/study that has positive results supporting 2-73's MOA.
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https://www.biospace.com/article/ucr-scientists-discover-potential-cause-of-alzheimer-s-disease-suggest-that-current-medications-might-hold-a-solution/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=190307643&_hsenc=p2ANqtz--J9cZPfplczkF1yJXcB5zkPpJtXXSi5gT5MSBuNDV52buRGYTBteqCsDqhO_1fRfOBXLYg5c5tXZDEpGvJTkPjh-UL7Q&utm_content=190307643&utm_source=hs_email
While the Biotech road has been rocky the last couple of days, our news continues to be positive while our competitors BIIB and SAVA face an uphill road with bad news. Here is the latest discussion of SAVA's plight.
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https://www.fool.com/investing/2021/12/02/should-investors-worry-about-the-federal-investiga/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
We of course believe that next year will be a very important one for AVXL....well get ready for M&A if we are successful!.
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https://www.fiercepharma.com/pharma/m-a-large-biotech-pharma-companies-will-have-1-7t-firepower-for-dealmaking-2022?oly_enc_id=6344A1822112C6Z
Lilly is very much encouraged by the FDA's treatment of Biogen's Aducanumab....accelerated trial outcome thru biomarkers. To bad that they will face 2-73 efficacy in the coming months.
"That opportunity, of course, is the FDA cracking open a window for accelerated approvals of Alzheimer's treatments based on biomarker data before true efficacy is revealed in clinical studies. Matthews has now shifted back to the Alzheimer’s portfolio to work toward launching donanemab."
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https://www.fiercebiotech.com/biotech/what-it-takes-as-lilly-s-alzheimer-s-drug-approaches-fda-drug-launch-leader-feels-amplified?oly_enc_id=6344A1822112C6Z
DOW down nearly 600 pts, SAVA nearly $4.....a not so good Tuesday.
"Stock losses accelerate as investors consider Omicron impact, Powell tapering remarks"
Think "Keytruda".
Climbing up the "Mountainside" with Anavex next week!
Xena.....you are the leader in DD....thankyou!
Talon
Bio, good to hear from you again....Happy Thanksgiving.
Talon
Agree strongly with you, Jimmy.
Talon
Al Sandrock the chief scientist at Biogen retired just as the controversy over Aduhelm's approval and safety has taken place. He led the Biogen lab when the 2-73 MTA for MS evaluation took place. I wrote a post at the time that the question was not about 2-73's ability to remyelinate the nerve bundles of MS patients, which was Biogen's ultimate goal for its MS research. But rather the competition was between 2-73 and Aducanumab/Aduhelm in the Alzheimer's drug quest and Biogen chose not to offer Missling an adequate amount to partner with us. Although Dr. Sandrock probably saw the data and potential of 2-73, the Biogen CEO, Michel Vounatsos and Board likely overrode his scientific arguments in order to maintain Biogen's MS drugs which provided 70% of revenues at the time. Sandrock's retirement more than likely came with a "I told you so!" note to Vounatsos!
We will ultimate see 2-73's safe application to many diseases to include MS.
See the great poster, "polarbear77's" 12/07/17 post #133249 for some thorough early DD that covers this.
Yahoo Finance reports AVXL @ $18.45 AH.
Old....Amen!
All the Alzheimer's stocks took a hit today. With all the talk of a possible take over, here is the recent example of a contested Merck/Acceleron take over.
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https://www.fiercepharma.com/pharma/merck-collects-enough-acceleron-shares-for-11-5b-merger-despite-loud-activist-investor?oly_enc_id=6344A1822112C6Z
It is rare that a drug struggles with public acceptance rather than regulatory acceptance which is the case of Biogen's Aduliem. Considering the medical establishments in Europe and the US resistance to Biogen's Alzheimer's drug, we are likely to be in the lead for FDA's New Alzheimer's Drug race with SAVA and ANVS trailing us. Our footing needs to be sure over the next 7 to 8 months in order to break the tape first though..
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https://www.investors.com/news/technology/biogen-stock-skids-after-alzheimers-drug-aduhelm-faces-a-setback-in-europe/?src=A00220
The death of a patient recently a recieptant of Biogen's Aduheim for Alzheimer's has the company concerned over this ARIA. It come at the same time Alan Sandrock, Biogens Chief Drug Scientist, has retired from the company. Sandrock was the Biogen supervisor of the 2-73 MTA of a few years ago.
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https://www.fiercepharma.com/pharma/biogen-s-aduhelm-could-be-linked-to-alzheimer-s-patient-s-death-analyst-says?oly_enc_id=6344A1822112C6Z
As I read the posts from day to day...and I read most every one...they generally fall into two categories, 1) comments on the clinical research of our drugs and 2) comments on the business practices of our small biotech. I think most of us would agree that our drugs have shown nothing but positive affects in both animal and human trials. As you have stated many times, there have not been other than safe and positive results. On the other hand, there is much discussion on how the small staff and our CEO conduct business and keep the financial world interested in our stock. We have have a lively daily discussion of both.
But what INHO is, is that we would all want to see is our drugs heal and help those who are suffering, from little girls to elderly grandparents. In that regard, I salute each one of you for your shared concern and look forward to the future. AVXL will succeed!
Agree wholehearted with you Falconer. The digram of our drugs and planned clinical trials has a orange bordered arrow indicating a P2/3 for Fragile X, thus is consequently in the planning phase. Our former FDA managers may be working a trial architecture with the FDA that will enable "Blanket Trial" expansion into other autism spectrum diseases. This is especially true of those which have uncontrollable body movements/spasms (like Rett, Frail X, Infantile Spasms, and Angelman's).
With the FDA's help the "plaque" side of the house is getting more than their fair share of press.
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https://www.investors.com/research/ibd-stock-of-the-day/eli-lill-stock-froth-surrounds-alzheimers-names-including-rivals-biogen-cassava/?src=A00220
Nidan....corporate hype certainly takes a second row seat to feedback from actual users. That's why the videos from "down under" were so effective....need a few more of them via Aussie TV. My prayers for your brother and your family.
Talon
Here is a little more info on Biogen's presentation on Aduhelm at the CTAD. They presented a few more of the caveats on the drug that the experts have noted before, i.e. the questionable data and the brain swelling adverse effect(to include a recent patient death).
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https://www.biospace.com/article/aduhelm-lowers-tau-protein-in-addition-to-amyloid-plaque-biogen-data-shows/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=182080732&_hsenc=p2ANqtz---Mwc5Aae_mmjkllzMxWLl8MF4o9p-i9u4x6U4oXT16uQexO82z4Rq6NGOyLcq2BntuGpS9zxQdXBQ6fIh9nK04U-Ecg&utm_content=182080732&utm_source=hs_email
Biogen and Easai are at work bolstering Aduhelm at the CTAD. We'll see how the Alzheimer's world thinks of their drug's defense.
"Eisai Co., Ltd. (PNK: ESALY) and Biogen, Inc. (NASDAQ: BIIB) announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the Aduhelm Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer's disease. Reductions in plasma p-tau181 were also correlated with a lowering of amyloid beta plaque.
The pre-specified analysis of plasma samples was conducted by an independent lab, drawing from the two pivotal Aduhelm Phase 3 EMERGE and ENGAGE trials. The findings were presented today at the Clinical Trials on Alzheimer's Disease conference.
Biogen shares were up 3.26% at $275.27 in premarket trading."
Yahoo Finance shows a $.78 climb to $22.12 after hours while SAVA lost 11% today, but took back $.90 after hours.
Nidan....your are preceptive about what Janet Woodcock, the acting FDA Commissioner, has to bring to the table. The FDA having approved the latest Alzheimer's drug will have to respond to the world's question of it's credibility. Rather than go into a defense of Aducanumab, more likely she will talk about the other drugs such as AVXL's and SAVA's being the pharmaceuticals in the US's broader approach to the disease. Whether she mentions us specifically, she will have to point to all the efforts the FDA is pursuing to meet 2025 Alzheimer's goals.
Alzheimer's study from Cambridge University on the front page of Fox News today. Doesn't say whether it was a peer reviewed study, but describes the tau and amyloid plaque effect in the brain. Does say that "science" does not know what causes Alzheimer's , but that tau/amyloid plaque are detrimental to the brain's processes. Not definitive findings, but you can bet Biogen will point to it as underpinning Aducanumab's validity. It does not appear to shine a light on the cause of Alzheimer's, but to verify the results of the disease and a general time frame for its progression.
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https://www.foxnews.com/health/alzheimers-study-reveals-how-disease-progresses-in-brain
Without solid trial data, AVXL runs the risk of being in the biotech sector with flawed companies like BIIB, SAVA, CRTX and ANVS. We need strong clinical results or we will be tarred with the same scrutiny that befalls the questionable news out of our competitors. Need to see strong Rett/PDD results soon.
The Alzheimer's market is a little "frothy" with SAVA up almost 10% on nothing new other that they might present at the Alzheimer's Conference and its 3rd Qtr report.
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https://finance.yahoo.com/news/cassava-sciences-sava-post-q3-153203047.html
Who knows what will happen today in the market....maybe Halloween two days late...AVIS is up 100%/$165 just on earnings report. They are biting on anything...lets get our lure in the water.
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https://finance.yahoo.com/news/avis-stock-goes-wild-162955610.html
This is what Yahoo Finance carries as its last article on CTRX, yet the stock in in the green and up nearly $.50. So how do we interpret the market this morning?
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https://finance.yahoo.com/news/cortexyme-investor-alert-kaplan-fox-222300899.html
Flotsam as well as surfers travel on the big waves. SAVA, CRTX, BIIB and ANVS are up on the same wave with no good news at their backs. Such is the market.
We are fighting the "flench" affect.....with the BIIB, SAVA, CRTX and ANVS bad news, the buying public is hesitant to accept the good news/performance of AVXL. As said many times, it will take trial progress and the biotech sector response to such in order for the sp to climb significantly higher. Were we a bigger company with inroads to the press, IMHO we would see quicker movement. We will have to accept slower sp movement to remain a small but independent company. Common Sense!
Falconer....you are right, the competition is making all the wrong moves with Biogen and Lilly chasing after the "flat earth" theory of amyloid plaque, SAVA and ANVS facing taxing investor legal action, CRTX down over $100 since Aug 8th and now Novartis finally throwing in the towel on AVXS-201.....we are "rounding the turn" with quite a lead. Missling is not even using the whip! The data in 2022 will keep us in the lead and the roar of the crowd is in the final stretch.
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https://www.fiercebiotech.com/biotech/novartis-dumps-rett-gene-therapy-caught-up-zolgensma-scandal-cull-pipeline-prospects?oly_enc_id=6344A1822112C6Z
Lilly is using Biogen's Aducanumab as its "poster child" and wants an accelerated path way to boot. The FDA is rueing its Biogen approval decision more each day.
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https://finance.yahoo.com/news/1-lilly-raises-2021-outlook-105041604.html