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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.
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!!!