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The company has not announced the letter of intent that I am aware of. I would not be surprised if Missling never announces the letter of intent.
You can post whatever opinion you want. Expecting everyone to agree with it is unrealistic. This is an anonymous message board which lends itself to people behaving more poorly than they would in a face to face situation.
If a little name calling is a bit too much for you then ...
Actually they did. The EMA approved 2-73 for the centralized approval path which is a necessary first step in the overall approval process.
If that was not approved it would be game over for AD in the EU.
How about a little subtlety.
The Rett trial was not the clear success that was hoped. Everyone can agree with that I think.
It also wasn't stopped for futility which is a clear failure. Although that didn't stop Adulhelm from going forward after two trials were stopped for futility and it was still approved. So there's that.
There was some evidence of efficacy in the trial. That level of efficacy did not rise above the placebo effect sufficiently to meet the P<0.05 requirement.
There is also the anecdotal examples of reduced seizures in Rett girls. The trial did have a seizure log as a measure. Whether the seizure logs support that as a real result could have an impact on what the FDA thinks about the overall trial results.
So, whether the Rett trial results in approval or not is still up in the air. That decision will be made by the FDA. If the FDA says go ahead and submit an NDA the trial was was a success. If the FDA says run another trial to clarify the situation the trial was not a failure nor a success. If the FDA says don't bother with an NDA the trial was a failure.
What can be said is that endpoints were not met with P<0.05.
There are other factors that are involved that are not included in your analysis. There is unmet need which may mitigate the only one P3 trial issue. There is also the very low SOC which may have the AD results viewed more favorably than your analysis considers. There is the relative safety of 2-73 to be considered. One can argue that a safe but ineffective drug still doesn't get approved. However given that the approved MABS have marginal efficacy and significant safety issues, it is hard to predict where 2-73 will come out in that evaluation by the EMA.
Then there is the financial burden issues of AD. The EU seems to consider that with the rejection on the MABS for a cost benefit ratio consideration. 2-73 looks to be considerably cheaper that treatment with the MABS.
The points you make are legit. I'm suggesting there may be other considerations that are not included in your analysis.
We shall see what the EMA decides in due course.
Pivot is not word used by Anavex. It is a description used by posters on the MB.
The initiation of the 3-71 trial is a normal development of the drug pipeline. Nothing more and nothing less.
The company can do more than one thing at a time and develop more than one drug at a time.
You know the only thing that has changed is the Rett trial. That was expected to be a clear success and it wasn't. Whether it was a clear fail will be decided by the FDA. We don't have the answer to that yet.
AD is still moving forward and a new trial for 3-71 has be initiated.
It may not be WGT and it still looks pretty good to me.
It is not a 7 month wait after filing. It is a 7 month wait after notification of an intent to file. A significant difference. The actual filling occurs after the 7 month notification of intent to file. There are some circumstances that can shorten that time but it seems that most cases require the 7 month wait to actually file the MAA.
Thank you for bringing that data to the board.
Investor, Please go snipe at someone else. I have no desire to play your silly games.
I think you read too much into the 3-71 trial. That is the normal progression of developing a pipeline.
Doc, so far the regulatory agencies have yet to express an opinion on 2-73 in any trial. So we don't know how convinced or not they are.
We have your opinion, informed as it is. The agencies will see a lot more data ,in much greater detail, than any of us has seen.
We shall see what they have to say.
My reply was to someone else who made the claim that the Blackrock Anavex shares were only index funds.
Sometime ago I posted a Blackrock discretionary fund that owned Anavex. I'm sure you can find more if you are interested.
Seems to me it has worked out pretty well.
Money in the bank. Approval process started for AD in the EU. Rett is still alive, if delayed. Schizophrenia trial initiated.
Not nearly as fast as people want.
Well pogue you may be right, but I don't share your view.
Rett was a setback. It is not lethal. The FDA might accept what Anavex has now or it might require an additional trial. Either way my view is Rett isn't dead.
AD is still in the pipeline and making forward progress. Not at the rate many would like but still forward progress.
I can't speak for others here, but I can say that I have learned from those here that have a core position and also have trading positions. I have found that to be a successful combination.
YMMV
There have been multiple opportunities to make significant money on Anavex in the last three years. If you haven't taken advantage of those, that's on you not Anavex.
If you start with with ten patients and then have twenty that is 100% growth, i.e. growing fast.
Blackrock does a lot more than just index funds. It has a number of different portfolios that it creates and manages.
For example.
https://www.fidelity.com/managed-accounts/portfolio-advisory-service/blackrock-investment-management
I'm sure their research staff is not any better than what we learn from a message board and reading PRs and SEC filings. Lol.
A normal person would ignore him.
Sell half your shares and force the issue.
20,655,976 shares @ $6.60 = $136,329,441 short position.
Seems likely that there is some effort to protect that amount of money.
At 5% interest on that money they are receiving $568,039 a month in interest.
In answer to your question as to what is standing in the way of filing NDAs for various indications.
PDD Too small of a trial. Only one trial.
PD No trial at all for PD.
AD Filing process started in EU.
Adult Rett Small trial. I suspect the FDA would rather have a filing for pediatric and adult in one NDA.
Pediatric Rett Awaiting guidance from the FDA on the current trial. See adult Rett response above.
My guess is that the US and AU filings for AD are waiting on pediatric Rett guidance from the FDA before a decision on those filings is made.
You flatter yourself.
Very nice up day. + 9.09%
A moderator only has to follow the Ihub rules when deleting posts. If you disagree on a deletion you can always ask for a review by admin.
Aside from that there is no requirement for a mod to have a position on the stock one way or another and a mod can be just as much of a **** as any other poster.
Don't have you blocked. Only one person blocked and that is on another board.
She was not a morning person.
Link to that please?
I can predict with 100% certainty that you will continue to be a condescending PITA.
Predictions are hard, especially about the future.
Please explain how publicly dissing the CEO in the Wall Street Journal will help the share price? If anything that cause any potential shareholder to reconsider buying.
Why do you think the Mayo has any skills that are not already on the board? The guy does a very good job as an information gatherer and analyst. The board already has access to all the information that it feels it needs.
Good question.
My sense is that your #2 item is correct. A good peer review will establish the MOA and the legitimacy of the approach to CNS.
I doubt that the company would be making so much of the peer review paper unless they thought it was going to be a positive for the company.
Actually several PRs have mentioned that decisions were made based on discussions with the FDA.
So, swing and a miss on this one.
Avxl hasn't tanked. It hasn't soared as expected.
Avxl is in a holding pattern until there is clear results from an agency, either pass or fail.
It remains to be seen what Missling's strategy is moving forward. I suspect he is waiting for guidance from the FDA on Rett to decide what to do vis a vis AD. Obviously Anavex has started the process with the EGA. The timing on that process doesn't preclude Rett obtaining a voucher.
If the FDA says it wants an new Rett trial my guess is that Missling will go full out on AD.
In the mean time the company is moving ahead on schizophrenia and hopefully announcing other trials soon.
As a friend of mine pointed out one time, it is important not to make a decision until it is necessary to make that decision.
The peer review paper is largely out of their control. The process can take months or a year. Once the paper is accepted for publishing it is up to the publisher as to when it will be published. The publisher can hold the paper for a theme edition for example or choose to get in the next edition as important information.
So I suggest decoupling the paper from the rest of the events as you think about the company. Yes having a paper published on Monday with great results would be most desirable. But as we have seen with the Rett results, the paper may not be the very positive outcome we hope for.
Overall the fate of the company is determined by approval for an indication. That approval is determined by the trial results and the agencies opinion on those results.
Basically we investors are along for the ride. The choices are simple. Stay or go.
Ok. After drawing the line in the sand and it is crossed then what?
It's probably more accurate to say that most people on this board regret that this board is treated as an info war.
There is a small group that relish the info war much to the annoyance of the rest of us.
Alas, they were, along with other items that didn't happen.