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Ihid.....welcome to the fight. The offense has more weapons and more being added daily. Great minds are providing effective tools and we are getting them earlier in the "struggle". Cancer free in a 15 year battle. Prayers for your defense, mind and body!
Talon
Short Squeeze....this expression has come up frequently of late and may have been a part of the movement of our competitors SAVA, ANVS and CRTS at times. This article explains the mechanics of the process and some other typical market moves which confound us ordinary investors.
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https://www.investors.com/how-to-invest/investors-corner/short-squeeze/?src=A00220
Nidan....you are up on frequency.."Loud and Clear"! Looks like your knowledge/analysis is being uploaded and when completed...."Cleared for takeoff". Glad you're back.
Talon
Tradeherpete.....The rocket scientists are busy helping old amyloid plaque drugs find revival.
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https://www.biospace.com/article/roche-s-alzheimer-s-drug-finally-gets-fda-nod/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=169539858&_hsenc=p2ANqtz-_sf9KVJ5-bvPxndUhubi9rtCwRS0SVHQTPtPiaZk8NEYc5HrgsUMr-Qlth3c-YTG4aLefNvpRKzqdQddrEULAhTyYlkg&utm_content=169539858&utm_source=hs_email
God bless and keep you.......pray you are in caring and competent hands.
Talon
Happy Monday....Washington is a mess economically....the whole stockmarket is in the "red". And wouldn't you believe....China's Evergrande is leading the gainers at nearly 18% after falling perceptively in the last week!!!
Let's be a little kinder torward those who post here....there has been a lot of outside influences (Covid, the movement of the economy, government/regulatory turn over, other company hype) which has caused our share price movement. Not much the Anavex management can influence. Know all of us would like to be in the seat next to Chris and whisper in his ear as the events cross his desk. But consider this....our company has two drugs in multiple trials. they are doing very well and there are a number of other diseases which beckon us forward. If you stated with the company when it was a "penny stock", you have seen 1000s of % appreciation and if you only started your investment this year, you have experienced more than 300% increase. If the effacey outcome lives up to expectation, the world will be measurably healthier and your accounts will be far outreaching your spending plan.
So give your friends like George who bring an immense amount of information to the board a bit of credit and be happy with what God has provided us.
Thanks and a good weekend to you all.
Talon
Biogen and Eisai are doubling down on the Alzheimer's door for amyloid pathology that the FDA has opened. Don't believe that the scientific and buying public is too excited about this move. Let's see if the FDA has become more cautious.
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"Eisai Initiates Rolling Submission Of Regulatory Application For Accelerated Approval Of Partnered Early Alzheimer's Antibody Treatment Candidate
Eisai Co., Ltd. ESALY +1.5% and Biogen Inc. BIIB +0.9% announced that Eisai has initiated a rolling submission to the Food and Drug Administration of a biologics license application for lecanemab, Eisai's investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease.
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology.
Biogen shares were edging down 0.22% to $286 in premarket trading."
Great news "B".....an electronic crash instead of a mortal crash....still flying after dropping below the deck on the go around. Will copy you tomorrow afternoon. AVXL still airborne!
Talon
SAVA must have a good IR desk or a strong contact at Yahoo because the article that was quoted was for a time on Yahoo's front page and they now list SAVA in their "Top Gainers" with nearly 9M shares sold.
Talk about making a market out of thin air!!
SAVA is up another $7 on what has been acknowledged as a shaky analysis of a small (50) P2. On top of that, it has been an open label trial, but the analysts and the press have played the stock up over 900% on speculation. As someone has said, it is a good stock to speculate or short.
The slow but steady rise of AVXL has been a bit frustrating when you look at SAVA, but the over 300% appreciation this year is performance that over 95% of stockholders would gladly accept.
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https://finance.yahoo.com/news/opportunity-brewing-cassava-stock-says-163955185.html
Anavex the Company plan to increase their scope of drug development of 2-73 and 3-71 to include now unregistered clinical trials for:
1. Fragile X
2. An unnamed Orphan drug
3. Parkinson's Disease
4. Prophylactic Alzheimer's Prevention
5. Frontotemporal Dementia
And a number of possible associated CNS diseases.
The $150M is from stock sales which will be sold from "time to time" according to the following statement from Anavex:
"
USE OF PROCEEDS
Except as described in any applicable prospectus supplement or in any free writing prospectuses we have authorized for use in connection with a specific offering, we intend to use the net proceeds from the sale of the securities under this prospectus for working capital and other general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses and technologies, although we have no present commitments or agreements to enter into any material acquisitions or investments. We have not determined the amount of net proceeds to be used specifically for such purposes. As a result, management will retain broad discretion over the allocation of net proceeds. We will set forth in the applicable prospectus supplement our intended use for the net proceeds received from the sale of any securities."
The "smoke and mirrors" of our close competition according to MF. One thing is for certain; that closest competition is not going to accelerate past us on the way to NDA for Alzheimer's with the FDA.
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https://finance.yahoo.com/m/bc5d0aa9-c8a5-3058-9cec-64dd64fc3519/why-shares-of-cassava.html
ANVS is up what we are today and Yahoo Finance has about 10 law firm notices soliciting "class action" suits.
You tell me the logic....SAVA up $7.40 today on 9M shares traded, yesterday it was 22M. And the last 4 articles Yahoo Finance is carrying are "class action" suit calls from various law firms. I guess any publicity is good publicity!
Plex.....SAVA is talking as fast as it can to the FDA and its share holders. With its current plans it will be way behind AVXL.
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https://www.fiercebiotech.com/biotech/cassava-drops-interim-alzheimer-s-data-plenty-caveats?mkt_tok=Mjk0LU1RRi0wNTYAAAF_rXJQQQijAIPDCQK7tm_fF2iSBWPHSamicSlAXWSMFfrOfqvYEgsGp4Oq39yaeMoBUPfKAgP1OhyRwf4WXwiQp9ccgJDGRlvD4tqjzi492aVPfAyk&mrkid=6254940
Red Shoulder.....think we are talking about a "scope" issue, meaning how is a company of around 30 employees going to manage manufacturing. quality control, transportation/distribution, marketing/sales, advertising, finance, government liaison and a myriad of other things. And conduct the 2-73 and 3-71 clinical trials work load that is keeping them fully occupied right now.. Internal expansion will take money and the time that everyone is clamoring about. Formulating the right partnership would speed our drugs to market, timely help patients and put money into the shareholders' pocket sooner. A successful example is Merck and their drug Keytruda which has partnered with numerous other successful drug companies.
Red Shoulder.....good analysis of the market's apparent faulty DD of the Alzheimer's leading biotechs. It comes as a failure to look at the science and clinical history of the three companies. It will soon sort out DD shortfalls when the clinical data is presented by AVXL.
On another drug development issue; the question of partnering or going it alone on 2-73. The accompanying article on Novavax is pertinent to that question. Novavax is working on vaccines and has a very promising COVID19 candidate for which the Govt has paid them $1.6B to develop under "Warp Speed". Although far more well financed and a bigger biotech in size, it is finding it hard to bring its COVID19 vaccine to market despite that significant funding. Setting up the manufacturing/distribution infrastructure in the US has been a problem while handling supply issues in the UK, Europe, India and Japan. While the vaccine issues are far more pressing than what Anavex faces with Rett, the bigger market for Parkinson's and Alzheimer's are going to entail the same demands on Anavex when 2-73 is approved.
Thus 2-73's success will require us to line-up some very qualified partners to insure that success penetrates the market when our science is recognized by the needful public.
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https://www.investors.com/news/technology/nvax-stock-buy-now/?src=A00220
More studies on "brain plaque". Still the question has not been answered, "cause or result". When the 2-73 P3 is completed, then then answer will be clearer for the world. Don't think Biogen is going to get $56,000 per application of Aducanumab.
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https://www.biospace.com/article/alzheimer-s-space-remains-hot-as-researchers-identify-achilles-heel-of-amyloid-beta-peptides/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=159415522&_hsenc=p2ANqtz-9BrnD6KB-RSSIQsIv8xN8GX2qKP0OgSYrv8d9tAPoH-SZESWertxCXQm1XItszoMTFyLjMtl2IaczjIQwqp-4uJmevVg&utm_content=159415522&utm_source=hs_email
The law firms are gathering the class action suits around SAVA.....a turbulent time for the stock.
Power ....to you and the NYFD for their love and duty toward their fellow man some 20 years ago.
May AVXL climb the mountain in support of those many who are facing the medical threats to their life today.
Power....the brave in this world run towards its dangers!
"Have you heard from Nidan"....no Power, hope he's on a fishing trip to Tahati without internet service. That's where I'd like to be during all this COVID mess. It defeats the candidness of this board, but maybe we we should indicate a contract person in our personal data in order to track us if "we go deep and run silent". Hope you are well, Nidan.
Bless you and have a rewarding week Power.
Talon
SAVA above $50 and ANVS above $35, does it spell manipulation with all the negative revelations about the Alzheimer's drugs of these two companies. Too many corporate investors thinking that if Biogen and lilly can do it, we can ride these weak horses a while longer. AVXL will in time unseat them!!
Tred....having carried those un-named devices for a number of years, I am glad that the threat was enough to deter having to use them. However, companies like Biogen and Lilly sometime live in the world of profit and not necessarily truth. The FDA is supposed to demand the proof of truth to the public good before allowing profit...or at least that's what the Agency was designed to do. Yet to see what they, the Congress and the public sector will ultimately do with the Alzheimer's/Dementia candidates. If merit in the way of efficacy and safety are given priority, it will restore some faith in the FDA and this sector of the economy. We can only hope.
Talon
Power....my service was for the honorable citizens, like you, of this Great Country. Thanks for the salute to the military and the first responders. There will always be an America as long as there are patriots as yourself who think of others before themselves. There are so many on this board who prize the gift of health to those in need as a goal which is of equal purpose to their investment. I salute you and our fellow members. May God look kindly on our efforts and the effectiveness of our medicine.
Excuses continue with Biogen's Aducanumab/Aduhelm. The $Bs planned after its rollout will not happen once 2-73 is approved for Alzheimer's. By the way....would you buy a used car from Vounatsos. I know that is not very nice, but after what Biogen did to get approved, it is warranted.
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https://www.fiercepharma.com/pharma/amid-rocky-aduhelm-launch-biogen-ceo-says-there-s-too-much-confusion-misinformation-and?mkt_tok=Mjk0LU1RRi0wNTYAAAF_a3MRDKyi5SevHpmIdGcO8T23567698JeVGHoeS0iZEkf2wjXqL-8tOR1ytIX9FkyLTgKJA8qxFexWbuctOi9Vxs8ePMuEdw83Uc0AkQHI0KXiolo&mrkid=6254940
Amen, Tred
Lilly is trying to surf the same wave as Biogen. They are pushing their once discarded drug down the same amyloid beta/tau path. Very telling for all their work is the statement that they will find out if "Will these Alzheimer's drugs evan work?". The last paragraph of the article is very interesting.
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https://www.fiercebiotech.com/biotech/lilly-s-alzheimer-s-moment-has-arrived-after-biogen-plows-through-fda-gates?mkt_tok=Mjk0LU1RRi0wNTYAAAF_ZVBiN4HZdl35SaCLUVqt4j1vkjd0_SlKdKRsbUj87Bvn5dqVySqvdOd4ZEyDGPvMkpoEbqvU8PCIMjg-TmzHjvZ8JfDjFGEdUPiB6pSEq2isYzRP&mrkid=6254940
Interesting to gage the future. On one side is the public interest in a free society....keep the citizens safe and reduce health costs. That should be the federal/state government goals. On the other side is the profit of the drug and health care industry. There is room for both. Our concern is the greed of some in both the government and industry to put profit above public interest when promoting breakthrough drugs and medical techniques. We hope for the egalitarian approach to drug discovery when it comes to 2-73 and its treatment potential, especially prophylactic, for the CNS world. I believe that we as investors and proponents of beneficial human (possible animal) health are on the side of long term success. I salute your courage, fortitude and dependability.
Falconer.....you have enumerated several Autism diseases that 2-73 may be effective in. This is the status that the "Blanket Trial" is designed for. It would be an ongoing trial in which the Autism family of diseases would be investigated. The knowledge/data from one disease would possibly be revalent in others and speed up the development process and scope of the drug. As a side line, Janet Woodcock pioneered this trial concept during her tenure as the head of CDER.
Congress is jumping into the middle of the Alzheimer's and amyloid plaque controversy. The disruption of the process will go on thru the nomination and the Congressional certification of the new Commissioner. And the outcome of the process will be a much closer review of future Alzheimer's drug candidates. Dr. Missling is not anything but conservative in his approach to bringing 2-73 to NDA which is a great plus except for its time frame. IMHO the advantage of Anavex in the Alzheimer's race will be the data management of the Rett and PDD. The wait for us may also fall on the long side due to COVID which is turning out to be more complex in both its medical and political nature.
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https://www.fiercepharma.com/pharma/first-biogen-now-fda-congressional-democrats-request-agency-records-over-approval-for?mkt_tok=Mjk0LU1RRi0wNTYAAAF_R1niVrb-YvhrWUXKho1mIppA-IDm4ydfTLFXWoYG0Sa0Mq7KHVOI2P13WUliH1IyUmSVR7nWOkWkje4wGyCraltk3cqYJBvWW6rDJaNe4mbQKULO&mrkid=6254940
The pricing factors for medicine are complex. They include severity of the medical condition, patient density, manufacturing, ingredient cost/availability and competing drugs to name a few. What is certain is that the politicians and public are more attuned to the rising cost of pharmaceuticals. I'm not aware of the cost concerns in the FDA's and other national drug agencies' approval decisions, but keeping dosage cost down is a growing factor in the pharmaceutical world's marketing. Here is where Anavex has a leg up because of the large CNS disease populations, the multi-use of the drugs and the possibility of prophylactic use. Short term investors certainly want to front load their investment, but we longs want a more realistic, universal and beneficial approach to cost.
Steady....but you don't expect the Rett cost to set a precedent with the health care system?
How are you going to charge one patient $500K for the dosage you are charging another patient $10/day and vice versa? That would be not logical even with a difference in sevarity.
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 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 it's self 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."
Amen Steady!
More SAVA "plummeting" at $70 with CRTX @ $102 now taking its place as the Alzheimer's leader.
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https://www.investors.com/news/technology/sava-stock-plummets-on-claims-of-data-manipulation-in-alzheimers-testing/?src=A00220
The press says Cassava has plummeted, but since the stock was about $3 a year ago, it has hardly plummeted at this point. This came about after SAVA's CEO brought out interim data...that should give Missling some thought about doing the same. Much back and forth to come , but the market is not throwing SAVA out with the bathwater yet. Same has characterized ANVS after the bad news at AAIC 2021.
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https://www.investors.com/news/technology/sava-stock-plummets-on-claims-of-data-manipulation-in-alzheimers-testing/?src=A00220