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I guess the longer we wait the sooner the OLE results will be released.
It is very clear that very few here understands that using AUC is nonsense with just 3 data sample points. There was only reason for it and that was an attempt at 'fixing' the failed Avatar trial, which was then confirmed by the failed Excellence trial.
We can hope that the plaintiff lawyers can't think what it is they need to discover.
Yes the consolidated complaint and the opposition to the motion to dismiss is not nailing why the change of endpoint to RSBQ AUC is an issue. Likewise, associated to that the plaintiff lawyers are not nailing why Missling's explanation for dropping RSBQ AUC in the Excellence trial is nonsense. The problem is likely that they don't understand the subject matter well enough. Nor is scienter addressed, as the Anavex lawyer highlights, which is key to the merit of a case. Again here that links back to not understanding and then clearly writing in the complaint and opposition to the motion why AUC is nonsense, especially as there are only 3 data sample points. Nobody is nailing that, including 'biotech investors' here, but that was a deliberate change based on likely having realised that the midpoint data sample was the one most likely to show response.
This may be the get out of jail card for Anavex.
I’ll just note that you are unable to understand the key argument in the Blum case, which is the change to AUC in AVATAR and on who’s guidance that then did not apply to the EXCELLENCE trial based on another obscure explanation by Missling. You see Missling won’t be able to explain the AUC fix and hence I would go for discovery of evidence explaining that change and it won’t be based on advice from a regulatory agency.
But ok you don’t feel mislead by Missling and don’t understand unrealised profit either from a trade that only exists in the digital realm until an action may take place that makes a realised gain or perhaps a loss. Paper admin of trades was a few years ago.
Hopefully the MAA filing and its approval chances lands in the 83% bucket, which would go a long way to fix the Missling mess and look forward.
I know! Everything Anavex and by implication their lawyers say is always right when WGT bias is applied.
Do you understand the AUC vs Baseline to EOT issues, especially when trial only had 3 sample points; baseline, a mid point and eot? Can you see its nonsense or are you able to explain why it wouldn’t be?
I have a fair amount of experience in the field of U.S. Securities Class Action law and systems to support the associated workflows.
I’m not in the business of advising lawyers though or investors, but have read and analysed more cases than I ever imagined I would to design systems and with input from several of the law firms in that field.
You must have as well given your solid opinion on this case in opposition to my own?
If I was the Blum plaintiff lawyer my next step would be to ask for discovery.
Since AVATAR had no U.S. trial sites or an IND filed with FDA, I would want to see evidence from Anavex that a regulatory authority eg. HMRA in U.K. recommended and/or accepted the use RSBQ evaluated as AUC rather than Baseline to EOT. That is key to the case and if Anavex can’t produce that evidence it’s very likely they will need to settle.
Wrong on both counts, but I’ve come to expect that.
Actually I’m in digital profit on my latest $AVXL by a smidgen.
Anyway keep an eye on the Blum case and forget about Huey.
I’m long and hopeful that Missling and his backland isn’t completely insane knowing that not filing the MAA this year is very unwise - it needs to happen!
But I might be wrong 😑
You and Hosai are looking at the separate and ill stated Huey complaint.
The Blum case and their response to the motion dismiss is the one to focus on.
So far taking long for release of trial outcomes has meant a need for creativity results presentation, sometimes of the kind that can end in class action complaints.
So far the motion to dismiss has not been granted. Also note there are now two separate cases and imo the Bloom case and that response to the motion to dismiss is the one we now wait to see the outcome of. Forget the Huey case.
There is no doubt, as I have pointed out way before this case, that AUC was a nonsense attempt to rescue the outcome of the AVATAR trial, which to date Missling has refused to reveal the Baseline to EOT RSBQ result with CGI-I anchored or not. From the data we have seen it is clear why Missling is not keen on showing that originally published primary outcome measure.
Any near term valuable future for $AVXL rest on the AD MAA being filed and approved. Without that plus a potential class action settlement is a disaster at least for current investors. Good to know that we have an 83% chance approval, right!
With the Bloom case the 40/60 chance of settlement vs. dismissal is at least as valid as your claimed 83% chance of EMA approval for AD.
We have no choice but to wait for the outcome of both and I hope Bloom lands in the 60% bucket and MAA approval in the 83% bucket.
Your imagination seems fully functional albeit a little biased.
Having read through the "MEMORANDUM OF LAW in Opposition re: 36 MOTION to Dismiss" this morning, I am afraid that the Security Class Case does have merit and will continued.
As I have posted over the last few years, since the AVATAR readout, the RSBQ-AUC used to 'rescue' the failed trial is complete nonsense. I have done my best to explain why - and based on very simple fact that a biotech investor should/must understand. I have also shown in the written notes from Anavex slides that the FDA Guidance referred to is on anchoring a caregiver subjective score to a Pro-score e.g. RSBQ by caregiver scores anchored to the physician observed CGI-I score, as ultimately used in the also failed EXCELLENCE trial.
Hopefully Anavex does have sufficient D&O insurance, as I suspect an early settlement will be the appropriate outcome. After that I would think Missling will no longer be allowed to continue presenting the company's clinical trial communications. I could see him as a good CFO.
This case is now firmly in the 40% bucket of those that settle. Hopefully the EMA MAA submission for AD, if and when it is filed, will land in the 83% bucket to balance out this mess and get Anavex under management that can do a better job of leading the SIGMARCEPTER platform potential towards possible approvals.
I don't think Anavex, as some claim, is a deliberate scam just poorly managed.
The PDF of MEMORANDUM OF LAW in Opposition re: 36 MOTION to Dismiss . . Document filed by Quintessa Huey..(Apton, Adam) (Entered: 09/13/2024) is now available from Courtlistener.
The argument against the motion to dismiss is now focusing in on the Rett primary endpoint change to the nonsense RSBQ-AUC vs. the protocol RSBQ-CGI baseline to EOT score that Anavex continue to withhold.
Unfortunately this securities class action case is not dead yet.
How many statisticians does it take to screw in a light bulb? kinda thing. But I guess if 87,000 employees each deal with say ten numbers, then things could go faster until their results gets to the guy/girl that have to quality check and assemble them into a useful conclusion.
Is there any statistically significant evidence that shows statistical analysis is easier and quicker for companies with a BP large mcap vs. one the size of that Anavex have?
Surely an Ex-FDA head of bio-statistics should amply make up for BP mcap, especially with a trial 6 times smaller and likely using the same or similar software for the calculations.
But bot articles can be really nice and comfy.
Some bold / confident statements from Missling - hope they will pass the regulatory reality check.
But there is an 83% chance of EMA approval. What could possibly go wrong?
Just always remember one can only trust small trial results from Anavex and never from any other biotech - WGT!
PS! this includes of course drip fed post hoc updates often over more than a year since failed TLR.
I was on public transport today and saw directions to ECTRIMS and thought - I wonder if 328 is in town.
I forgot to mention that humor perception in schizophrenia appears to be related to disorganisation syndrome.
With a schizophrenia trial there can be ambivalent opinions on pretty much anything including trial size and purpose.
They must if withdrawing an application unable to satisfactorily respond to CHMP requests and questions. A material event.
Less likely that a clock stop pass is the subject of a PR, but could come up in say a quarterly report or during analyst Q&A.
The prerequisite for all that is that Anavex actually do file and have accepted an MAA.
For what it is worth your post demonstrates that neither LLMs or you understand statistics and biotech well.
Try continuing your thread with ChatGPT buy arguing against and point or two from it’s answer. You should not find it hard for it to reply with conflicting answers.
Your WGT persistence is likely much better than that of ChatGPT.
That study actually makes a lol sense as the first time I've seen a plausible explanation for the fact than amyloid plaque is not directly correlated to AD dementia.
The fact that a large proportion of people with PET indication of plaque don't exhibit dementia has always been the elephant in the room of the plaque theory.
My trading is a bit longer term than yours, I imagine.
I will be selling as always next time perhaps we see an irrational price spike, for example on a paper or MAA PR that could overshoot the price of $AVXL while we wait for the possibility of real value.
I couldn't believe what I was reading back when that paper was published. One thing I felt sure of was that all the WGT folks would not understand or accept that results discussed are a generated fantasy prediction about as accurate as Georgejj forecasting $AVXL short squeezes.
Trust "the science"!
At least I'm up on y $5 trade 😀
On AVATAR it appears quite clear that Anavex did not receive direct guidance from the FDA. Anavex may have receive direct guidance for the only IND trial ever, which was the really small n=6 Adult Rett trial conducted entirely in the USA.
Anavex made it appear as if guidance was received from FDA or people inferred as such for example on this MB regarding the use AUC, which was just an Anavex nonsense 'fix' for a failed AVATAR readout avoiding to show the per protocol endpoint outcome measure of RSBQ Baseline to EOT. There exist no such FDA guidance on using AUC, but Anavex are referring to FDA guidance in their slide on anchoring to a PRO-Score (in this case anchoring RSBQ to CGI-I, which is not specifically mentioned in the referenced FDA guidance. The AVATAR trial had no location in the USA.
Interestingly Pro-score anchoring (and AUC) was dropped for the EXCELLENCE failed readout. I suspect that Missling may have received strong advice from internally in the company (Kun Jin) to not again come up with some lame 'fix' and have the analyst rip it apart. The Excellence trial was not expanded into the USA, only Canada and the U.K., why should the FDA have been involved in that.
Have Anavex had any direct guidance from the FDA on anything so far other than Adult Rett, who knows but it isn't very likely given that the only IND was for the tiny Adult Rett trial.
Nice story spun out of nothing.
That’s how we have a market.
That’s the trouble, nothing seems to motivate Missling to perform to his own stated expectations.
Oh my I am up 11 cents on my trade the other day, things are looking up!
Well at that strike price surely the higher $AVXL is trading the better for Missing too.
On the other if he is playing for a small gain exit from those options, it would be in line with his penny wise pound foolish strategy on clinical trial operations.
If so Anavex would really be a Madoff rather than TGD outfit.
The question though is why?
“Missling I see that he seems to be working for his next "salary related option grants" coming up in early 2025....a big chunk, 500,000 !!!!”
Cause that won’t help him much with $AVXL moving continuously in the wrong direction.
For me the trend is confirmed every time Missling opens his mouth in front of investors.
And of course every time Georgejjl makes a wrong predication, which happens continuously.