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I am reminded of a comment by Carl Sagan " Extraordinary claims require extraordinary evidence".
Anavex is challenging the entire Alzheimer's disease paradigm.
So yes, the FDA will be looking much more carefully at Anavex's data and trials before granting approval.
Submitting an article for peer review is the first step in a long process. When and if an article gets published is not under Anavex's control.
As far as the NDA, it will be for Rett. Missling has said repeatedly that Rett will be first.
The NDA will be filed when it is ready.
As far as I can find there are no fees for meetings with the FDA. There are fees for filing an NDA which as far as we know Anavex has not yet done.
Even so the NDA filing fee is waved for an NDA for an orphan drug. 2-73 has orphan drug designation for Rett so no NDA filing fee.
FY 2023 and FY 2024 User Fee Rates
Fee Category Fee Rates for FY 2023 Fee Rates for FY 2024
Application
Requiring clinical data $3,242,026 $4,048,695
Not requiring clinical data $1,621,013 $2,024,348
Program $393,933 $416,734
Designated Orphan Drug or Indication:
An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.
It's also pretty hard to classify Anavex as a genomics company.
Yes they do a lot of genetic information gathering but so far they are not using it in any trial for patient selection nor is Anavex editing genes in any way.
Still, the publicity is good.
Those are not mutually exclusive statements.
Pursuing AA aggressively means convincing the FDA to accept AA as opposed to conventional approval path. That doesn't say how fast Anavex will file the NDA seeking AA.
Anavex has stated it wants Rett first for quite a while.
Rett has the lowest risk and the fastest path to approval.
Bitch bitch bitch. Anavex is doing just fine. Once Rett is approved the floodgates will open.
I recall posters saying that starting new trials now for different indications is a signal that 2-73 doesn't work for Rett or AD and the company is trying to salvage something from a failed drug.
The MOA has to be proven. Rett will do that nicely. At that point starting trials for different indications will be viewed as a positive rather than a negative.
Oh and the company will have assurances of an income stream which will mean that $150MM will be no longer needed as a safety net incase the FDA doesn't like 2-73 for some reason.
Hope for the best and plan for the worst.
Hope you are right.
Missling has made it clear that AD will happen after Rett. Therefore he is in no hurry to move AD forward in a public way. That would create more pressure to file an AD NDA.
That doesn't mean that they aren't busy getting prepared for FDA meetings on Rett and AD. The effort should be on the Rett NDA application with attention to what portions of the NDA can be written so that they can be directly used in the AD NDA.
I wonder if the FDA is willing to tell Anavex that if the two NDA applications overlap that it will not grant AD before Rett. If there were any delays on the Rett NDA and the AD NDA was in the system Anavex could lose the voucher.
Larry, Do not put words in my mouth.
Dr. Hagerman said she wanted to take 2-73 for her aging. Since she was running an initial P2 trial she was keenly aware that the drug was not on the market.
So she was expressing future intentions. That is obvious to anyone that wants to see.
2 years later she is discussing Fragile X and the drugs that are in trials for Fragile X. That did not include 2-73 BECAUSE IT IS NOT IN TRIALS at the time.
Again, that is obvious to anyone that wants to see.
So she doesn't mention Anvex, so what.
You don't suppose that has something to do with the fact that there have been no trials of 2-73 for Fragile X do you?
Dr. Hagerman made her remarks were made Dec 16 2020.
As I recall her presentation she said that 2-73 should be approved.
The company has said that it doesn't want to become involved with compassionate use out side of trials, OLEs.
Not a successful spin job.
Dr. Randi Hagerman has already said that she thinks 2-73 will be effective in Fragile X. She said that after running a Rett trial. See her words below.
This is a relatively unique medication that can actually improve the calcium dis-regulation, the mitochondrial function, the oxidative stress and the neural connections. These problems can be seen in variety of other neural developmental disorders and also neurodegenerative disorders.
They’ve carried out studies in Alzheimer’s and in Parkinson’s Disease looking at cognition in Parkinson’s disease. It improved cognition in both Alzheimer’s and Parkinson’s disease.
I do a lot of research also in Fragile X syndrome and this medication can improve the Fragile X symptoms in the mouse model of Fragile X so I’m very excited about this medication causing improvements not just in Rett Syndrome but in other neuro-developmental disorders and neurodegenerative disorders.
This medication can be a boon. I think in general for aging and certainly for aging syndromes like Parkinson’s Disease and Alzheimer’s and I can’t wait to start it on other neuro-developmental disorders like Fragile X Syndrome.
I am very excited about this medication and also as I age I would definitely like to take Anavex myself.
I’m excited that this is a break through medication and for not just Rett Syndrome but other disorders of aging and also neuro-degeneration.
Maybe I am naïve but I don't think the shorts are worried about Anavex and any impending news. I do not know what techniques they have available to protect themselves from a sudden price rise but it seems to me that they have such techniques available to them.
We saw some of what could happen with Game Stop. The first thing that was noticeable was that the hedges were able to lay hands of large sums of money in an attempt to wait out the share price spike. We have also seen days in Anavex where there was huge volumes traded out of the blue for no particular discernable reason.
The volumes of those days would allow the approximately 18 million shares shorted to get lost in the mix of trading.
My admittedly crude calculations value the present short position at close to $250,000,000 so they have a lot of room before they get hurt.
My guess is that if there is a short squeeze they will wait for the peak and short some more and try to work the SP back down over a period of days or weeks. These guys have big bank to work with.
Bottom line for me is that if there is a short squeeze it will be quick spike followed by a decline in the SP. Personally I'd love to see the shorts get burned, I just don't think it will happen.
George, you are stating the obvious.
It is a safe bet that most of the major pharmas are watching Anavex and trying to figure out how they can make money, be that partnering or purchasing. Some of the BP are watching Anavex just to understand if and how much of a threat it may be to their portfolio.
It is also a safe bet that they are low balling Missling which is why he has stated that no partnership till approval which is when he will have much more leverage in the partnership negotiations.
You need to look at 1 month chart. Sava is about $1 above where it was before the University report on possible fraud was released.
SAVA is up from a huge negative hit to basically where it was before the short attack.
Falconer, I have always appreciated your posts/writing.
I will quibble with this statement.
On this message board we have a wonderful diversity of readers, all of whom are here to learn.
Thank you Mayo for that analysis of the paper. Those results are much stronger than the Anavex PR would suggest.
While murine data frequently doesn't translate into human data, these results are very hopeful for the coming human trials.
If the human results are even 1/2 as good as the murine results then 3-71 will be a massively successful drug.
Missling's negotiations problems just got a lot more complicated. Partners for 2-73 will be wanting to have 3-71 as part of the deal because 3-71 could well replace 2-73 in a few years. Missling can control some of that by getting 2-73 approved for PD, PDD and some other indications and only trialing 3-71 for AD so both drugs can be on the market simultaneously for different indications.
Missling now has to wait to see what the FDA wants to do vis a vis AD approval. If no additional trial is required he can move forward with 3-71 P2/3. If an additional 2-73 is required I would expect him to hold off on the 3-71 P2/3. Having both of those drugs approved close to the same time is not a good business strategy.
Could MIssling blow off AD for 2-73 if the FDA wants a big long trial? Just take approval for Rett and go forward with PD, PDD, Fragile X and start pushing 3-71 for AD? That would be making a risky bet that a P2/3 for 3-71 would lead to AD approval. Very interesting possibilities coming up.
In the meantime, Rett is the most important item on the schedule.
If Dr. Randi Hagerman wants to take 2-73 for herself as soon as it is on the market, she will be really excited about taking 3-71, as am I.
Given Missling's reluctance to discuss any meetings with the FDA, I'd say we won't hear anything until an NDA is filed.
I'm a few minutes late reporting but I picked up some Jan 2025 options today. Probably pick up some more Friday or next week.
It turns out that most of the world is not black and white but shades of grey.
Anavex has its warts. That doesn't stop a careful evaluation of the science. Many think that Anavex has a viable drug in 2-73. If they choose to express that as "I believe" that's fine with me.
Milestones are targets set in advance. Progress is completed trials. Progress is what will make us investors money not milestones.
Anavex PR'd a murine study for it 3-71 drug candidate. What would you have them do, just sit on that and pretend it didn't happen?
That is a piece of useful and positive information.
We shall see what Missling decides to do for a 3-71 P2 trial. Your guess is as good as mine.
You might consider that Anavex gets Rett approved and has a significant revenue stream. 2-73 gets approved for AD and Anavex partners and now has very big revenue stream. At that point it can develop 3-71 and not need a partner and can go it alone if it chooses. 3-71 will take 5 years to get to approval at least. So Anavex will have plenty of time to reap the rewards of 2-73.
It all depends on what MIssling and the BOD's vision of the future is for the company.
Anavex has other molecules to develop.
Promoting and reporting are two different things.
Putting out a PR for a high quality peer reviewed paper of a drug candidate is not promoting.
There were no hyped up claims made about 3-71. The PR quotes the paper's authors for the claims being made.
It also made clear that only a P1 trial has been conducted in humans.
Missling has made it clear no partnership until approval for AD.
Are there conversations going on? Missling has said that there have been multiple companies reach out to Anavex so it seems clear to me that conversations are going on. Missling has positioned Anavex to be able to SIGN a deal on its terms when it wants to.
Any buy out would be a hostile takeover and Missling has positioned strong defenses to prevent that. Missling knows what Anavex has and the potential the company has to become a big player. I think he wants to see that develop. That is his path to becoming a Billionaire.
Accelerated approval process was designed for dealing with trials of the type you suggest i.e. trials that require very long time frames to reach results.. The issue is figuring out which biomarkers are representative of increased longevity and then getting the FDA to accept them.
Mostly this paper suggests that Anavex is not just a one trick pony. Rat data is a long way from demonstrating efficacy in humans. It is suggestive for sure.
Having a successful P1 for 3-71 is a necessary but not sufficient step towards demonstrating efficacy.
I look forward to seeing what Anavex does for a P2 trial.
Not a chance. 3-71 will have to go through a P2 trial to demonstrate dosing effectiveness for a specific disease, likely to be AD. It will be tested in people that have been diagnosed with AD to show effectiveness.
Only then would Anavex even begin to consider a trial for prophylactic use. Even then it would probably not be tested until some of the new AD diagnostic tests become available that will detect AD pathology before a person shows any symptoms.
Such a trial would require a large number of subjects and be multiple years long. Anavex has better options in choosing trials to get 3-71 on the market.
Once 3-71 is on the market conducting a prophylactic trial makes sense. The same goes for 2-73 and generalized aging use.
Accelerated approval takes the usual 10 months after the NDA filing is accepted.
Perhaps you are thinking of Fast Track or Priority Review designations.
Latest Short interest data.
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
10/13/2023 17,806,100 724,390 24.58082
09/29/2023 17,965,522 886,663 20.261951
09/15/2023 17,087,678 1,098,054 15.561783
08/31/2023 16,878,865 621,130 27.174448
08/15/2023 16,721,112 1,075,407 15.5486
We see what the short interest numbers are. There are still about 17,806,000 shares short out there. The new short interest data came out this afternoon. That number is a settlement date of 10/13. That number is down aprox. 160,000 shares so it would appear that the shorts are greedy and experienced.
At $5/share, only the greediest or least experienced shorts are still in their positions with a ticking clock.
Several points. The FDA may well have looked at the data Anavex showed them and said, submit the full NDA and we will decide after we have the complete package to examine. We like what we see so far, but we want to see all of it before we decide. Nothing material about that.
Let's assume the FDA has told the company it is likely to require an additional trial. Likely is not definitive and therefore not material. Again, until the FDA takes an official action there is nothing material.
So if the company does get advised that an additional trial is likely to be required. The company announces that and the share price gets hammered by AF and his ilk. Not a good move.
Better to wait until Rett TLR and an NDA is filed before sharing that the FDA is likely to require an additional AD trial. Waiting on Rett will mitigate any share price drop from announcing that an additional trial might be required.
Thinking the stock will run up to $10 to $15 on the FDA requiring an additional trial seems pretty far fetched to me. The shorts will have a field day with that set back.
Rett is what will make this company a success or send it down to the $1 range if it fails.
"silence is STILL NOT and effective communication strategy".
PR'ing meeting endpoints is the material event. If the company has already Pr'd that they have met the endpoints then sharing the data set with a prospective hire who's expertise is data analysis would not be a material event. At the least that person would now be subject to insider trading rules and most likely the person would be required to sign an non disclosure agreement.
Got it. Thanks. I try to be even handed in getting both sides is the childish name calling wars.
I have no idea what data Anavex has received or when they received it about AD. Nor do I know what meetings Anavex has had with the FDA, when they had them, or what subjects were discussed. I pretty sure nobody else on the board does either.
I do know that Missling has said it is Rett first. So publishing AD data and then waiting till the Rett NDA is filed and accepted would create a wide window of time for the negative forces of the market to pick at Anavex and the AD data. Why create that opportunity for the negative forces? Yeah, they are picking at the company for not presenting the data now. It could be worse.
Rett is what will make the company successful. It will happen sooner than AD and according to the board experts Rett has a higher chance of success with the FDA.
I'm not any happier with the current share price than most people here. We wait for the NDA and FDA action. Those are the events that will determine the company's future. Unless MIssling can put out a steady stream of very positive news till the NDA is approved, my view is that at best those PRs will create a short term pop in the share price and then the share price will drop back down again.
My calculations, as rudimentary as they were, value the short position to be worth close to $250,000,000. You can be certain that there are people paid to protect that position. The shorts might well like to see short term pops in the share price to have more opportunities to short it back down and increase their profits. The short position is as large or close to as large as it has ever been and that is in the face of what appears to be very promising news in the next 6 months or less.
Be careful what you wish for. Unintended consequences do occur.
That is because that is not Anavex's decision. That will be decided by the FDA. Maybe in pre NDA filing meetings or maybe not until a full NDA is filed.
we still do not know if we will need additional trials or not, for Alz atleast.
Right now I'm ready for the first bite. 🙂
Not just RETT but the whole enchilada.
I'm seeing more posts deleted by Admin for personal attacks. It's looking like the rules for a PA are now back to about what they were prior to the great leap forward.
Admin, is that the case?
Looking for a little guidance as a mod.
So it's $140M. Sue me.
And how do you know there hasn't been a raise?
Missling has been pretty consistent about maintaining that cash stash.
Let's see how that would work.
Missling puts out a Pr saying the company is on track to release data by EOY. AF or someone like him immediately puts out a tweet or SA article saying the company needs that much time to try and find a way to massage the data to make it look good otherwise why has it taken so long to get the data out, result is a further SP drop.
Missling buys 10K shares. AF and the creeps put out a PR saying the company is desperate to support the SP because they have nothing and are trying to keep the company alive. They won't mention the $150 million in the bank. The SP drops.
Now we get to the really silly one, taking part of the $150 million in the bank and doing share buy back. If even there was a transparent effort to support the share price of a non revenues producing company a share buy back is it. Result, the share price drops after AF and SA write a scathing article about how stupid and transparent the buy back is and explain that the company is in such deep difficulty because the drug doesn't work that it has to do a buy back.
Missling is in a no win situation until the gets an NDA filed. The longer the time period between the Rett full data and the NDA is more opportunity for the shorts to work the SP back down from the full data.