The SEC definition is at odds with clinical trial outcome statistics.

“Trial success is not material because that is the presumed outcome. Most companies would PR a trial success since that is a positive piece of news.”

If the SEC was right about their definition it would be really easy to be a biotech investor and the returns would be poor.

Missling, who some believe is truthful, has stated several times that an MAA filing will PR’ed as indeed pretty much all companies would.

Missling perhaps?

Yes I normally phrase it as approval from existing clinical trial results.

If provides solid support to existing claims and / or new ones, then yes chances can be updated/adjusted.

No-one appears to have asked your chances of EMA approval for A2-73 in AD, where are you in the spectrum of Doc's 1% and the 83%+ of some?

Well the good doctor talks to a slide that suggests that A2-73 could be used together with Mabs for their combined potentially beneficial effect.

It does make sense to remove the amassed neurotoxic effect of built up beta amyloid plaque, while A2-73 starts to prevent new forming by restoring autophagy.

Lol! That was one hell of short squeeze Georgejll - are you happy?

I guess I should be keeping better tab on where Leo might be at any one time.

Yes but as opposed to the Paris one and $AVXL, I’m not aware of the one in Montreal having recently burned down.

I saw the Notre Dame before it burned down just as I have seen $AVXL before its meltdown, but significant progress has been made on rebuilding Notre Dame.

Yes and still down 31.50% from max over the last 12 months.

Remember they were smart enough to sell again?

Yes it makes sense that it would fall out that way.

You probably missed the context, but its fine and not at all unusual around here.

What shares? I thought no one believes I own any $AVXL shares.

Maybe you are asking for an ignorant friend?

As it happens a lead plaintiff was appointed 13 July 2024 as per docket 31 in the Blum vs. Anavex case and as also recorded against the Downing v. Anavex case!

How about a board with the CEO’s uni buddies approving compensation schemes and rewards for non-performance and one missed catalyst declaration after the other?

I’m confident your comment is idiotic.

Yes the original move by Anavex lawyers to attempt a pre-agreed motion to dismiss on no further plaintiffs joining did not work out.

We will need to see if the 3rd complaint will be consolidated into the Blum vs. Anavex case, then with 3 potential movants for lead plaintiff unless a later motion to dismiss is granted before certification.

Personally I believe a lead plaintiff will be appointed and the case certified, which if it happens can still result in a settlement or dismissal.

I can’t call that yet, but some lawyer here and others seem convinced of a dismissal even with prejudice. Likely the same folks that are 83% - 100% sure A2-73 will be approved based on current clinical trials.

Just read the July complaint filing on Recap and it relates to Blum & Downing vs. Anavex case. It may well be too late to file in Blum case, but may be regarded a so-called interveener case and slip through as another potential lead plaintiff motion based on an extended class period. Hard to say though since the Blum vs. Anavex amended complaint is not yet on Recap to read.

Kaufmann is not exFDA, but yah true one the exFDA dudes is gone and we have no idea what the other one is doing.

Kaufmann did fail to fulfil the Anavex strategic goal of rare disease approval and revenue as the top priority, instead of AD. With the Excellence fail, Anavex is now back to hoping for an AD approval before one in a rare disease.

Could be lining up to let Kaufmann go...but I still see Kaufmann on Anavex.com as part of the Management Team.

Well there is new case just filed 15 July and an earler one from May accepted as related to Blum vs. Anavex.

The Blum vs. Anavex case has an amended complaint filed 12 July, which now awaits reviews, motion to deny and in turn the court's opinion. What new Jully 15th complaint is about and whether is will be deemed related to Blum vs. Anavex, I don't know until perhaps someone Recaps the complaint so we can read without PACER access.

This won't go away for a while even if in the end it all turns our "bullshit" as per your lawyer technical term. It will be distracting though and not helpful to Anavex.

Why do you and others here care so much about who has sold or owns $AVXL as if belonging to some policing organisation with an objective of controlling who somehow qualifies for ownership?

Personally I don’t care who owns how much or not, not my business to know like some inspector Clouseau.

You are at risk of reading too much into the EMA PR from Anavex. So you agree with my assessment of the Rett situation?

I choose to believe it is Sunday with the same conviction as some believe TGD is infallible.

I really don’t care what you believe or not Catdaddy, but wishing you and the cats a lovely Sunday.

Of course irrefutable readouts matters even when not correlated to market reactions. Your statement is simply emotional rather than one of a rational biotech investor.

What works well for me, and should for any biotech investor, is well designed trials with readouts that are complete, positive and irrefutable per protocol and if changed done in a clear manner supported by relevant regulators and made public well before readout instead of post hoc.

Some seem to believe that it is too much to ask of a pet biotech company with a revered TGD.

and everything else from Set Theory to Statistics and decent message board behavior.

That's because Anavex don't have an approved drug or hard information that they soon will have to move the company closer to revenue, so marketing is all they've got just now - and it works beautifully on retail biotech 'investors'.

Anavex have so far run all too small n and too short trials both in Rett & AD with designs that have provided unreliable, but indicative results that A2-73 may well have merit. All of them with long running OLE and compassionate use access to A2-73, which is likely a positive but won't take the place of hard controlled trial outcomes (despite a KOL having apparently told Missling so).

The U.S. adult Rett trial was so small that it could not have provided any other but false input to the design of the EXCELLENCE trial. The AVATAR trial was also too small, too short and with too few sample points. Then at last moment using a nonsensical AUC outcome measure, most likely done because the placebo response was so high that the trial otherwise would have shown a clear fail.

The EXCELLENCE trial was not only too small and too short, but also designed with 2:1 drug/placebo arms, which it seems amplified what Anavex should already have learned - that is a high placebo response is likely especially in a short Rett trial with subjective scoring outcome measures. Anavex did not learn or were unwilling or unable to execute a well-designed trial.

Now finally Anavex will likely be forced to run an appropriately designed Rett trial, unless by some regulatory miracle their already planned next Rett trial ends up being unnecessary.

We are also eagerly awaiting another potential regulatory miracle in Europe from the P2b/3 AD trial, which has a non-zero chance of approval (<50% imo others feel even less).

The modus operandi of Missling is penny-wise and pound-foolish!

Hopefully A2-73 will be effective for Asperger’s.

Just remember that when you get on your bike for those long excursions - sell your $AVXL position first. No good to be long while on those rides other than the hair do and goatee.

They would likely both miss.

I was having tapas while counting my chickens and I did have an organic local brewery beer.

By not having AD yet!

Maybe just enough for a larger cardboard box in prime position at a better underpass?

Yes and ask Hoskuld why he disappeared for a while.

And you are as certain about all this as you were about Excellence?