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No! They went to Australian instead. Anavex as far as I know have filed only one IND for the US Adult Rett super tiny study.
I just realised how much I missed your posts.
But why would any company be sponsoring unless they know their drug is a great success?
Just like the WGT contingent here believe anytime Anavex show up for anything - it just wouldn’t make sense, would it?
I wonder how cheap one could buy $AVXL in December with no MAA filing announced.
I had an afternoon nap and a WGT dream, so I woke up and bought a bit more $AVXL at $5.
Probably soon turn into a nightmare…
Exact!y! Remember that $AVXL can always be bought cheaper...it may well be that the longer we wait the cheaper it can be bought!
But other than that its all great!
I guess we will know before A2-73 gets that far if Prilenia’s Pridopidine doesn't land in the 17% bucket, then we could be in with a chance 😀.
I knew there would be a WGT explanation - comforting end to another schitti $AVXL trading day, thanks!
Hey Georgejjl, $AVXL really going close on or near the low of day again?
I’m not sure I want see whatever Missling have in his back pocket 🫣
The imaging trial has been played down before, but the whole PDD / PD affair is taking forever. I don’t see much purpose in an imaging trial, a sufficiently powered P3 PD/PDD trial would be more relevant.
Is there no WGT dry powder left to make this $AVXL thing great again?
I’m sure all the traveling and socialising can be quite straining even on good pay.
It’s always all fine because the longer we wait the sooner we’ll get rich.
Think we might still have to fight them on the beaches.
Looks like Bas and Georgejjl are firing their dry powder at $AVXL this morning in anticipation of a huge bomb being dropped on the shorts today.
So exciting - there is bound to be a WGT PR just before Missling starts dropping the big news in front of a gobsmacked room full of investors!!!
It means it won’t happen as some investors anticipate, but the company expects them to.
Maybe that will one day change, but not holding my breath.
I write that because of long exposure to some WGT sentiment here that still seems to see things as given.
Oh that's a revelation!
Anavex mentioned a confirmatory trial.
Gotta mean Missling has something new and exciting to announce to investors, as he always does at these presentations.
So you must have read this as it comes before what you are quoting:
“The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients.”
Does Anavex have a confirmatory P3 initiated or not, simple question to answer.
If not, then the FDA is unlikely to grant AA from P2 data.
Bla bla bla - I’m talking about this: https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-issues-complete-response-0
And Anavex did not have and still doesn’t have a confirmation P3 trial initiated as they originally said they would!
As I said the FDA sees that as requirement for accelerated approval. Eli had one and Anavex don’t, which helps to explain why Anavex have not and are not currently approaching the FDA with the P2b/3 AD trial data.
I am simply suggesting that the market that does know about Anavex has priced in what is know about the company and its pipeline activities.
The point is that the FDA responded to Eli’s P2 trial results with an accelerated approval only because a larger P3 was already underway and would readout within months.
The FDA, sensibly, now require a P3 initiated as a condition for AA because too many companies have failed even years later to run a confirmatory trial. This is explains the reluctance of Anavex to file an NDA based on the P2b/3 results.
It was very disappointing that Missling chose not to follow up on Anavex’s own ‘expectations’ of initiating a parallel confirmatory trial after the disappointing, but not unexpected, P2b/3 readout.
The baseline data we have seen suggests a pretty uniform group of mild AD patients.
“Maybe patients with the most serious disease dropped out early, or those with a particular unfavourable profile.”
So probably not a key reason for early dropouts.
I think what you write largely only applies to those of us who know about Anavex and seek confirmation that we have made a great investment choice.
For the market in general, I agree with Hoskuld that a peer reviewed paper is unlikely to represent a catalyst that will do much to the value of $AVXL. Market opinion is a function of information and lack of already assimilated into the price of $AVXL.
In any event the paper is clear and supports what we largely already know and have had indicated, then it’s a good thing. An MAA approval and then in turn revenue is what $AVXL needs.
So in other words as a biotech 'investor' you can't be bothered to do proper due dillingence on your investment choices because its too hard, takes time and effort - got it!
The EMA stats are not irrelevant, but their WGT application may well be. I have in fact explained how a few times. HInt! it isn't as simple as 77/99, which anyone who looks deeper into the data behind those numbers should realise.
Hopefully EMA grants approval in some form, in which case I would be pleased to be proclaimed wrong. I do doubt I will get any bravo and don't need or expect it in case the MAA fails to be approved.
I guess it must feel nice to draw such conclusions on a simple basis (77/99), All done with little risk of $AVXL landing in that 22% bucket.
Good luck! I am currently only interested in the MAA filing and its potential approval. If that happens the rest is also great.
If, and that's a big if, a peer reviewed paper spikes $AVXL it would be a good time to consider taking some profit.
If and when the MAA is filed and accepted, there is at least a year until we see approval or we fail sooner on a clock-stop.
Starting new trials in between is great, but for a few years added expense until perhaps we see revenue form those efforts and investment. Short of the MAA being approved, there is no short term events ( a year+) to sustainably make $AVXL more valuable.
Well that’s the risk with using leverage. It is vapour money you don’t have and the broker needs to make sure that it doesn’t become money they don’t have.
There is no benefit to the broker by thinking: ‘well the stock in is this account has potential and looks really WGT, so we will run a margin balance that we may never get back”. There is no time think on a falling stock, only hopefully just enough to act leaving the client with as little debt as possible.
I have never and will never use margin or invest in leveraged securities.
Did you once believe a PDD peer reviewed paper was coming?
Correct!
It is critical that the MAA is filed in Q4, not so much to increase the price of $AVXL but to prevent it falling like a rock.
MTM is simply a here and now value accounting for an asset without any consideration to potential future value.
Isn’t margin call accounting still MTM, what else could be done for a broker not being complicit in gambling on things like an 83% chance of EMA approval of A2-73?
More pertinent is that $AVXL is under $8!
As I mention context is important.
Research on the Efficient Market Hypothesis (EMH) presents mixed conclusions. Early proponents like Eugene Fama argue that markets are "efficient," meaning prices reflect all available information, and thus outperforming the market is nearly impossible. However, studies have identified anomalies, like momentum and overreaction, which suggest that markets are not perfectly efficient. Behavioral finance has also challenged EMH by highlighting irrational investor behavior. Despite these critiques, EMH holds up in many cases, particularly in its weak and semi-strong forms, though it is increasingly seen as context-dependent.
Those irrational overreactions and understanding context especially biotech investors must take into account, for example by pretty much automatically selling on any price spikes that are irrational lacking any concrete news driving them. When to sell of course is more difficult in the present context of anticipation with price declining over time because of the well established context of distrust in the company's execution.
As a lawyer you would probably agree that 10b5 Securities Class Action cases, that now as a rule must show that a disclosure event was causative and statistically significant compared to market and sector, relies heavily on EMH. Indeed the norm for event studies is a window of max 4 trading days, but with a norm of just one day to show that market reaction was related to news. A longer window would conflate a disclosure event by other market or company related developments.
What exactly do you believe is not currently baked into the price of $AVXL? My guess of course is your > 83% chance of EMA approval just based on the agencies' recommendation to file an MAA. Surely the market has had plenty time to factor that in, but certainly your interpretation of reality has not been reflected into price - that much I would agree.
The point at which $AVXL will be recognised, is upon an MAA filing that gets validated and makes it past the clock-stops. The market simply doesn't expect that to happen just now and are ignoring the analysts rolling 12 months forecasts that are all based on approval and revenue, but do not discuss chances of approval.
Any midday revision to this?