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Rett and Fragile X are enough to make this company even if AD were to fail.
The company has multiple shots on goal. Rett is a high probability. AD looks pretty good. Then there is PDD and PD coming up. Fragile X seems to be a high probability shot and then whatever else the company wants to try 2-73 for.
That doesn't mention 3-71. We don't know a lot about how it will do in humans other than it had a successful P1.
How did you arrive that that short average cost basis?
I have wondered what the cost basis was. But not enough to do a spreadsheet and look up historical prices.
I put a second layer of aluminum foil on my hat and the board makes more sense.
That and using ignore.
When POWER11 speaks, people start laughing.
How's that 11 million shares doing for you?
The only thing I would add to your analysis is that most of Missling's compensation is in the form of stock options, so that 6.75 million is somewhat missleading.
And yes, you did say total compensation, which does include stock options, so you were correct with that number.
Last time I checked expressing an opinion is not a crime. Even if it is unrelentingly optimistic.
You give George way to much credit for influencing other people, kinda like you do for yourself.
If one has evaluated the evidence and come to the conclusion that the company has a viable drug then holding shares till the approval is not a problem.
The share price till now and then is interesting but not critical.
All depends on how you view the available evidence.
YMMV
TTJ Have you compared the AVXL short position to other developmental biotechs?
How does AVXL compare?
You should consider changing your alias to tootallJanus.
That's funny.😎
Two P3 trials is not a requirement. It is the norm. I posted a piece not too long ago that showed 42% of approvals were approved with one P3.
The FDA is flexible based on the strength of the effect and size of the P3.
Here is how the FDA views surrogate endpoints and their various uses.
https://www.fda.gov/drugs/development-resources/surrogate-endpoint-resources-drug-and-biologic-development#:~:text=A%20surrogate%20endpoint%20is%20a,to%20predict%20that%20clinical%20benefit.
It appears to me that the FDA is willing to look at new biomarkers, some without going through the formal process.
How this applies to surrogate biomarkers remains to be seen.
Anavex maybe waiting to see what the FDA has to say about Rett & AD to incorporate that into the next trial designs.
Given the state of flux concerning biomarkers knowing what the FDA is thinking might make a significant difference in the trial design.
That is my guess.
I would much rather have a meeting with the FDA on Rett and get their pulse on that.
I get that AD is the much bigger market. Rett will generate significant cash flow and will do so sooner. Rett approval will also give Missling much better leverage in negotiating a partnership deal for AD.
One important step at a time.
Drat. I liked school. I must not have learned anything since I didn't suffer. LOL
I get your macro economic angst.
There is always someone who correctly predicts a market crash. The problem is with so many people predicting a crash at different times someone will get it right. That person never gets it right a second time. It's like winning the mega millions lottery. Someone wins, but it is random. Even though the odds are so bad against anyone one person winning they sell many many millions of tickets so sooner or later someone wins.
AVXL is not a random lottery ticket. Most here have invested after doing considerable information gathering and evaluating the odds of success. The odds of success look pretty good to me.
If the overall market does crater AVXL will still do quite well, maybe not as well as it would do in a strong market but then in a down market it will be one of the few stocks that has a strong gain potential. After all, medical stocks do comparatively better in a recession.
Not only no, but HELL NO. We have already seen the high $20s.
Kinda like your 11 million shares?
And you probably still have your hearing in your right ear.
Damn, and here I am up over 100% in AVXL.
I'll stick around for the 3rd act. Seems that AVXL has a lot of good things on the table. We will see what the FDA has to say about it.
The only thing going down is the quality of your arguments.
I will give you props for the Monkey's song. Probably the best I have heard from Dolenz. Good tune. One I had not heard before.
My bad. I saw 10-11-12 and mistook that for the date... Actual date of that post was ...
That is an 11 year old post. Who cares.
Rett does have Fast Track which allows for rolling review of an NDA section by section.
That means that Anavex COULD have already submitted some sections of the NDA to the FDA.
Whether Anavex has done that is unknown. An NDA can be as much as 100,000 pages of information. So that is a lot of work to produce.
There are some sections of an NDA that can be worked on before final trial data is available. Where Anavex is in the NDA process is an unknown.
Missling is playing his cards very close to the vest. I suppose that is part of his "surprise the market" plan.
We stockholders are just along for the ride at this point.
You seem to ignore that Pediatric Rett approval will generate a significant revenue stream. At that point Anavex will transition from start up to revenue generating and profitability.
AVXL will one of the few places that in the down/collapsing market you predict that will have a share price up side.
That is correct. The last voucher sold for $102,000,000. Missling could choose to keep it and use it for the AD NDA.
Nah. That post was in response to a direct question.
When Anavex files an NDA for Rett I'll be all smiles and working on other things.
Sheesh Cat.
The man makes a reasoned argument. You may not agree with it so provide your own argument to show why you think it's wrong.
It turns out that there are multiple ways to see the same information. Some are more valid than others, but until the results are in no one knows what the final result will be.
I am reminded of a Buffalo Springfield song. There is a particular line in the song...
Headache and dizziness have been reported in the 2a trial as has lethargy in the Rett girls. Nausea was reported in the P1 trial at high doses.
Anavex hasn't provided detailed information on the other trials concerning exactly what TAEs occurred.
Not saying this is a problem. So far the safety profile of 2-73 is very good for a CNS drug.
I'm showing what Anavex has reported so far.
I'm pretty sure EBZ will latch on to that and say that is why some people are having issues with dizziness. 👺
Yogi Berra states: "It is difficult to make predictions, especially about the future."
Who freaking knows? Given the way the share price has responded with good news in the past, I have no clue.
I would think it would, but I have been wrong on that more often than right.
A peer review paper has more credibility than a PR about trial results from the company.
My opinion has been that a Rett approval will confirm the novel MOA of 2-73 and cause many people to finally take Anavex and 2-73 seriously.
We won't know if that really is the case until it happens.
I'm going to play devil's advocate on this issue.
I agree that slowing the brain volume reduction appears to be a good thing.
However, an alternative explanation is that 2-73 is causing moderate swelling of the brain resulting is slowing the expected
AD brain volume loss. Do I think that is the case? Not likely, but as a scientist you have to look for all possible explanations for the data.
The FDA will consider that as a possibility. Until there is evidence eliminating that possibility, it is on the table.
AFAIK Anavex has not looked at brain volume in other trials such as PDD or Rett. If there is no evidence of brain swelling in those trials then the possibility can be eliminated.
Science is a slow process because you have to eliminate alternative explanations before coming to a conclusion.
Physicist Richard Feynman once said, “The first principle is that you must not fool yourself, and you are the easiest person to fool.” One way we fool ourselves is by imagining we know more than we do; we think we are experts.
Check the FDA procedures. 6 months for Fast Track / Priority review. 10 months for regular review. Rett has Fast Track designation. AD does not.
The FDA is resource limited. They have to work hard to make the given timelines. They are not going to attempt to shorten them for Anavex.
BP would scream if they did that and rightly so.
FDA timelines....
File an NDA. 2 months for the FDA to decide to accept it.
Once accepted, 10 months typically to decide to approve.
That's year right there.
It is likely that the AD NDA will not be filed until Rett NDA is filed. That will be before EOY I hope.
So add some months to that year for Rett to get filed.
AD could be shortened up a bit if the company files for priority review which, if the FDA granted that, would shorten the 10 months to 6 months.
Missling has said he wants that $100,000,000 value for the pediatric Rett voucher. That means that pediatric Rett has to be APPROVED before AD is approved.
How Missling will choose to manage the timelines for the two NDA's is unknown.
No idea. I have learned not to try and predict PR's from Anavex.
I bought Jan 19 2024 options and am still a bit nervous about them if that tells you anything.
We all get our turn in the barrel.
All this discussion about AD. AD is a minimum of a year off if not a year and half.
Rett data is coming up and hopefully the NDA before EOY. Rett is far more important at this point in time.
Trial results are all that matter. The rest is entertainment.
This is a very entertaining board.
As a MOD I would suggest that if you wouldn't say something to someone's face don't post it on the board. This is not pointed at you but to the board in general.
Maybe Chicken Little lived in Tunguska.
I agree with your points. The question is really about how the FDA will view the biomarkers that are not recognized surrogate biomarkers.
The data presents a strong case in totality. The FDA does have some flexibility in what it chooses to consider but it does take into account precedent.
We will just have to wait and see how the FDA decides to act.
I can only find one accepted surrogate endpoint for Alzheimer's, that is reduction in A beta plaque.
Anavex does have several biomarkers that it is tracking in the AD trial but so far those are not accepted surrogate biomarkers.
How the FDA will evaluate those biomarkers is an open question. For example, Anavex has data showing activation of genetic pathways as a result of taking 2-73.
What the FDA will make of that data is unknown. Likely they will look at that and say it is interesting, do you have any proof that it results in clinical improvement?
Anavex is on the bleeding edge of AD research and drug development.