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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.
That argument is just wrong.
Number of BlackRock funds worldwide in July 31, investment style and fund type
Published by Statista Research Department, Sep 1, 2023
As of July 31, 2023, the allocation between actively managed and index funds operated by BlackRock was fairly even. Of the 1,098 funds operated by the world's largest asset manager, 590 were actively managed while 501 were index funds. Not surprisingly, the majority of mutual funds were actively managed, while only a handful of BlackRock's exchange traded funds were actively managed.
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.
Many of my fellow investors here consider my FUDster-IDing efforts very noble and needed.
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.
NOW you tell me.
Selling covered calls would be a better idea on this one.
My wife bought a grumpy cat mug that says "Good Morning.... No such thing."
Indeed lots of options to burn and many of mine got burned today. OUCH! 💥
No. Means no.
Yes I did feel the need to point out the assumption you made in your post.
Of course there is a possibility that there will be questions that arise at the scheduled clock stops, just as there is a possibility that there will be none.
How big an impact those questions will have, if any, on the total timeline is an unknown.
I doubt that many MAAs will go straight through without ever touching the walls within the CHMP offices.[/quote
Actually the average length of time for the EMA review process of New Active Substances averaged 436 days in 2018.
With the Accelerated Assessment option the average was 230 days.
So based on your logic every company in business is above board and never does less than an A-Plus job.
Got it.
You do realize that those clock stops are not mandatory right?
The clock only stops if the MAA has questions that it wants to be addressed.
Mrplmr, your posts are a one trick pony.
The presentation is available from the Anavex website. https://www.anavex.com/investor-material Listed at the top of webcasts.
Perhaps that is not a corporate presentation but just a J.P.P Morgan presentation.
Either way, the link is available from the Anavex website.
He types better than he speaks. WTF?
Companies typically hire specialist firms to do most of the NDA. That would be supervised by the excellent former FDA staff that Missling has hired.
For example. https://www.thefdagroup.com/blog/505b2
Application fee for orphan drugs is waived. So no charge for Rett. AD will have to pay.