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I think you are wrong.
You have a problem with them persevering for the last 15 years and getting paid for it?
Please explain what program you are referring to that would get it approved much faster?
There is AA, Rare disease to choose from.
Standard approval time frame is 9 to 10 months. AA is about 6 months.
Nonsense. The company has to file with the FDA first. Then and only then will the FDA look at the application. The FDA will consider that other countries have approved but will still look at the data. As I understand it, the FDA will consider the data provided as having been vetted, it will still require the data to demonstrate efficacy.
I am not suggesting that the data will not demonstrate efficacy. I am suggesting the FDA won't feel the pressure you suggest.
What a disingenuous post that ignores reality.
NWBO is a cash strapped company and has been for a long time.
NWBO chose to file in the country that has granted compassionate use for its treatment and has the most experience with the treatment. So yeah, they filed where they felt the likelihood of approval is the highest. That approval allows the company a revenue stream, a legitimization of its treatment MOA, and access to more funding at less than usurious rates. Approval in the UK would also match the production capacity with the demand as the company ramps up production capacity with EDEN.
Then application to the FDA makes sense, until then there is no point in getting FDA approval for a treatment that can't meet the demand. That would be business malpractice to get FDA approval
before the company has the resources to meet the expected demand.
But you knew all those things.
Indeed there was a lot of undue influence. Much of which came from the AD advocacy groups. The generous explanation is that they wanted something for AD patients even if it was minimally effective, it was better than nothing. The less generous explanation is those advocacy groups were supported by large donations from the companies trying to get their drugs approved so it was in the self interest of the advocacy groups to advocate for approval.
All in all, I see that as a political decision to satisfy the advocacy groups. The FDA had to know that the costs and minimal benefits would not see the drug be widely used. In fact the first one was withdrawn from the market place due to non acceptance in the market.
So the FDA threw a bone to the AD advocacy groups that had no meat on on it.
Somehow you seem to be focused on one poster that has an unrelenting positive view of Anavex. And yet you don't seem to have that same focus on the poster that has an unrelenting negative view of Anavex. Why is that?
It's like you think that one poster can actually make a difference on what the stock does or can have a significant influence on other posters.
I suggest you check your assumptions.
There was also genetic data to be sent to labs and evaluated. Gene expression and gene variants were also part of the other measures. Those things take time both to get back from the labs and to evaluate.
Most trials just use the standard measures, that are scale data, which is easily processed.
Yes it is.
The decision is based on the belief that Anavex will ultimately succeed. How ever it also provides enough time for an exit strategy if things look bad during that time frame. It will be at a loss of course, but as you have posted, sometime you make money and some times you lose money.
I still have the fundamental evaluation that Anavex has multiple shots on goal and it only needs to score once for there to be money to be made.
Some might call that WGT. Others might call that enlightened optimism. Either way, I have allocated money based on my evaluations of the situation.
All of my investments discussed on this board are out of my high risk trading account. If that account gets wiped completely out it would be really annoying. It would not affect my life style at all. If I make money in this account, it is all discretionary spending money.
Good luck to all that follow Anavex.
Sold a few shares and rolled that money into Jan 26 $10 options. My modeling shows that above a $14.73 SP the profit on the options is higher.
The article reaches people to create awareness of Anavex. That is a good thing. It doesn't have to be analysis by the best in the world to be helpful. If it was a slam job by AF would that make you happier?
My state's DMV is 90% funded by DL and vehicle registration fees. Does that mean that it is coopted by the driving public?
The FDA charges a user fee for services i.e. the costs of evaluating a drug application. The fee is paid up front. It is not contingent on approval.
It's not like BP can take their business elsewhere if they don't like the service or results from the FDA.
The FDA is the gateway to the US market which is one of the largest and most lucrative drug consuming markets in the world.
IMHO the argument that the FDA is corrupt because it charges user fees that make up 70% of its budget is bogus.
https://medicalxpress.com/news/2024-09-immune-cells-linked-blood-vessel.html
September 19, 2024
Editors' notes
Immune cells linked to blood vessel damage and neurodegeneration
by Bridget Kuehn, Cornell University
BAMs mediate the deleterious cerebrovascular effects of ApoE4 through NOX-derived ROS. Credit: Nature Neuroscience (2024). DOI: 10.1038/s41593-024-01757-6
A new study helps explain why having ApoE4—the gene variant most closely linked to Alzheimer's disease—increases the risk of neurodegeneration and white matter damage.
Researchers at Weill Cornell Medicine discovered that immune cells in the brain called border-associated macrophages (BAMs) are a source of ApoE4 protein and contribute to damaging blood vessels and brain tissue.
The study, published in Nature Neuroscience, may help scientists identify new approaches to preventing or treating Alzheimer's disease in people who carry the ApoE4 gene and other forms of age-related brain disease.
The APOE gene encodes apolipoprotein E (ApoE), which has many roles in the brain. It also has several common variants (ApoE2, ApoE3 and ApoE4), of which ApoE4 increases the risk for Alzheimer's disease up to 12-fold. ApoE4 also increases the risk of damage to the white matter that underlies vascular dementia, the second-most common cause of cognitive impairment after Alzheimer's disease. However, how ApoE4 produces these damaging effects on the brain is not completely clear.
"Our study points to border-associated macrophages as a critical mediator of these deleterious effects and helps us understand how ApoE4 may contribute to damaging blood vessels and brain white matter in patients with Alzheimer's disease or other forms of age-related brain disease," said the study's co-senior author, Laibaik Park, associate professor of research in neuroscience at the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine.
"We previously showed in another model that the amyloid beta protein that builds up in the brains of patients with Alzheimer's disease interacts with a protein receptor on BAMs," said Antoine Anfray, instructor in neuroscience at the Brain and Mind Research Institute, and first author of the study. This triggers a chain reaction that damages blood vessels, preventing them from clearing amyloid, which leads to degeneration of brain tissue.
In their latest study, the researchers show that pre-clinical models genetically engineered to express the human ApoE4 variant developed impaired blood vessels and tissue damage in their brains, while those with the more benign ApoE3 remain healthy. They found that BAMs with the ApoE4 variant produce inflammatory oxygen free radicals, which damage the blood vessels. As a result, blood flow needed to remove waste and repair damage to the brain tissue is limited.
Surprisingly, when the animal models with the ApoE4 variant had their BAMs removed, they didn't experience this damaging cascade. The study also showed that the BAMs are not only the mediators of the damage induced by ApoE4, but also the source of ApoE4 causing the damage. Accordingly, reducing ApoE4 expression in BAMs eliminated the harmful vascular effects.
"These findings show BAMs are both the source and the target of the ApoE4 necessary for damage to blood vessels," said study senior author Dr. Costantino Iadecola, director and chair of the Brain and Mind Research Institute and the Anne Parrish Titzell Professor of Neurology at Weill Cornell Medicine.
The investigators further confirmed that ApoE4 and BAMs transferred to animal models which didn't have the ApoE4 variant developed blood vessel and tissue damage. Alternatively, transplanting BAMs from animals with the ApoE3 variant to animals with the ApoE4 variant reversed the damage.
The findings may help explain why some patients are more likely to experience harmful swelling and bleeding in the brain when treated with amyloid-removing antibody drugs like Lecanemab, a complication most frequent in patients with ApoE4. This complication, termed amyloid related imaging abnormality (ARIA), requires the treatment to be stopped, limiting its benefits in slowing the progression of early-stage Alzheimer's disease.
Understanding how blood vessels are more vulnerable in some patients may help scientists develop ways to prevent this adverse effect by suppressing ApoE4 production by BAMs. Iadecola and Park are working on developing such interventions, but they caution that more work is needed before the findings can be applied in the clinic.
For now, they are looking for ways to block the receptors that mediate ApoE4-related blood vessel damage to reduce or prevent the genetic variant's harmful effects on the amyloid-beta clearance pathway.
"We now know that ApoE4 from border-associated macrophages increases blood vessel damage, but the next step would be to actually find a way to target the macrophages to enhance amyloid and tau clearance," Iadecola said. "Can genetically switching the ApoE4 to the ApoE3 genetic variant remove amyloid build up better? That will be proof-of-concept."
I haven't made up my mind about the Jan 26 options yet. They sure look attractive to me. If AVXL can't hit $10 by Jan 26 we are in deep doo doo anyway. So to me that leverage looks pretty good. The problem is I already have a bit more allocated to AVXL than I should so putting more money into it is an issue.
That is just silly. Even conditional approval gets NWBO a revenue stream. It would not impact EDEN development or the increase in treatment utilization that comes with EDEN.
No way on God's green earth that NWBO "test all time lows...".
Nice try but no cigar.
First of all, NICE doesn't matter in the near term after approval. There is more than enough money running around the world to keep NWBO and the manual process busy.
What you seem to overlook is that once DCVax-l is approved it has a world wide population to treat. Most of those people won't have enough money to afford the treatment out of pocket, however there are more than enough people with the money to be able to pay for the treatment themselves. Consider how many high end cars there are in the world. Those are people with enough disposable income that they can spend $100K+ on a car. If the choice comes between a fancy car and getting treated for a life ending disease, those people will find the money for treatment.
Then there are the folks that can raise the money one way or another. Just like we are seeing with the go fund me guy in the UK.
NWBO will have the time it takes to get NICE approval, which will not take nearly as long as you suggest.
Once EDEN is approved and there is much larger capacity having NICE approval will be important. Till then, not so much.
Please go short and tell us how that works out ...very soon.
This batch was in-the-money short term calls.
I do have some long term calls. Jan 17 25 and am looking at the Jan 16 26 calls.
I'm about breakeven on the long term calls historically.
The 2026 calls look attractive to me.
Closed out my Friday $5 options by exercise.
The FDA has nothing to do with determining prices for drugs.
That doesn't seem right to me.
That is always the question, how do macro economics affect the micro economics.
AVXL exists in a bubble right now.
The SP is controlled by the big players.
This is a news driven stock, till that changes, the players control.
Link doesn't work for me. Says page doesn't exist.
MM can see your bid on LVL III just as soon as you place it. Making your bid public had nothing to do with it.
It looks like your bid size is big enough that the MMs are seeing that as a floor. You might want to consider breaking your bid into smaller sizes.
I have gotten fills that way.
That was a 1 share trade at that price. Sorry to pop your bubble.
Nasdaq AH trades
Let's review:
There are a little over 19 million short shares. That represents approximately $105 million at the current share price.
Every $1 the SP goes up represents a $19 million decrease in potential profit for the short position.
The exposure on a short position is unlimited.
Since we don't know what the selling basis is for the short position we don't know exactly at what SP the shorts go negative on their investment.
There has been discussion that suggests that the shorts from a much higher SP have already closed out those positions and the break even SP for the shorts is closer to the the present share price. If that is true then a couple of Dollar upward move will cost the shorts $19 million or more. That is a pretty big liability.
So what you are suggesting is that there is no effort being made to protect that quite large Dollar amount in the short position.
Yeah, I don't buy that.
That is not a conspiracy. That is standard business practice. Some of which is illegal if the number of SEC enforcement actions is a guide.
We agree.
Add to that list. Don't play soccer or football.
Seems pretty clear about the purpose. Size is reasonable considering that it has to be inpatient.
It's a P2 trial. Its purpose is to determine dose in part A and then seek a signal in part B. That info will be used to design a larger P3 if the signal warrants.
It doesn't need to be a big n.
On a longer time scale you are right. Lack of execution and the Rett trial failure are responsible. On the short term, the SP is manipulated.
Typically Anavex follows XBI with a beta of 1.5 to 2.
Today XBI -0.72% and AVXL -5.70%.
As well you should.
Manipulation can go both ways.
Shorts are working hard today to keep AVXL from being up today. A 9K sh trade posted 4¢ under the bid to move the SP from green to red.
Turns out that was a swing and a miss.
The solution I learned from some of the people on this board is to have a core position so you don't have to worry about FOMO and to have a smaller trading block of shares. That way you can make some money while waiting for the big move.
Selling covered calls is one technique that seems to work pretty well. Another is swing trading over a few days to a week.
I have had moderate success with short term calls.
I was taking a bit longer view. AD plaques were first identified in the early 1900s. Tau was not identified until the early 1980s.
Early on I don't think that Tau tangles were recognized. I haven't researched that but I don't recall seeing any discussion of Tau until the relatively recent times.
The EU has just nixed the Mabs. It has almost no treatments available for AD. Anavex will be lower cost and will not require MRIs and infusions. MRI is not readily available in all EU countries.
My guess is that when the CHMP saw the data on AD from Anavex they thought it was a solution to their problem, if the full submission passes muster. So, they encouraged Anavex to apply.
As far a the Rett miss goes, it was close. The random factors broke the wrong way. A p=.05 still means that 5% of the trials will have the wrong conclusion.
Somehow I don't really care about the "smart money biotech investors".
Your argument is the "appeal to authority" argument. While an interesting technique, it has little bearing on the outcome of the trials and MAA / NDA filings. Those are the things that will determine the success or failure of Anavex.
Betting on the CEO is one option in choosing which company to invest in. It is not the only option.
Continue on complaining about MIssling. It's not like that is going to make any difference. You did see the outcome of the voting at the AGM, right? Missling apparently enjoys the support of the vast majority of shareholders voting.
Good luck with your Sisyphean quest.
But, but, but, Those companies had really good CEOs. I don't understand. 😉