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This is the thing of course that Missling is well versed in doing unfortunate things.
Beats me!
I wonder if similar extrapolations of the $AVXL price chart would yield results as promising...
You are super star Georgejjl - just amazing powers of persuasion and foresight. And that's without even mentioning your knowledge of set theory and random processes 🤪
Yes I agree. We will now have to see if Anavex is able to present an application good enough to pass under that low bar.
I’d say Feb’ish - always works!
You are referencing the old P2a study in Australia.
Try this one: https://clinicaltrials.gov/study/NCT04314934?cond=Alzheimer%27s%20Disease&term=anavex&rank=4&page=1&limit=10#study-plan
Now I’m not a biologist or even a biology teacher, but since this works in mice Anavex would be right to close down their Rett program.
In this recently published study based on research funded in part by IRSF, researchers applied a novel strategy to enhance RNA editing’s precision that proved successful in restoring normal MeCP2 in the brain of Rett mice. Read the article here: https://t.co/mdzn3UFyK8 pic.twitter.com/Afm2D2EUEc
— International Rett Syndrome Foundation (@Rettsyndrome) August 19, 2024
The effect of A2-73 in reducing brain atrophy seems small, but consistent across dosed completers, hence the low p-value.
We don’t know if that is clinically significant nor do know yet if the trend continues into the OLE, but being an objective marker it could help approval chances along with other objective markers of improvement in whatever subgroups analysis might show.
Yes look at the title and then ask yourself a couple of questions.
If only the trolls, bashers and fudsters were all banned from Social Media and didn't paint the tape, the price of $AVXL would have hit the ceiling years ago given all the penny wise pound foolish small failed clinical trials and no applications for approval filed by Anavex. Alas they are still here and the price of $AVXL is where it is because the paid pumpers are 3rd rate or worse and presents no competition at all.
What I’m saying now has no baring on poster titles and stats about them. So feel free to not repeat all that.
The SIGMAR1 wt. vs. Variant(s) turns out to have less influence on outcomes than the small P2a results indicated as laid out in the peer reviewed paper on the data and analysis of it. Too much soup cooked on a too small stone!
Missling has been downplaying the significance of the S1 wt. vs variant saying all respond regardless. Other factors are more important, which hope to learn about sometime soon’ish.
Instead Missling is emphasising that there is a correlation between increased S1R mRNA expression in those patients treated with A2-73, which together with clinical efficacy and other biomarkers is a good indicator that the drug’s proposed MoA is well supported.
Let’s see which potentially confirmed and new responder subgroups may be, perhaps at CTAD and hopefully more elaborated if and when the promised peer reviewed paper emerges.
Hey Georgejjl, get yourself some autophagy sleep - you'll need it as you wait for A2-73 to get approved. The longer we wait the sooner that will happen. Goodnight!
Well it was just meant as a joke on the logic in these kinds of proposals of faster than light communication or even travel, which have all so far have been shown are contra to our understanding of both classical and quantum physics.
Maybe that will all change if Missling one day actually gets an approval in the bag 😀
It is also a challenge to entangle two particles, then send one of them out to the distant alien to communicate with hoping that it all still works by the time there is something to chat about.
Alternatively the distant parties could just select some already entangled particles, where one happens to be located by the right ear of the alien, that is if they can find some way to communicate about it.
Other than that and a few other challenges, it is a brilliant idea.
696,193 is close enough to 10,000,000 for some. Sort of similar to meeting all endpoints even with a failed co-primary one and almost nearly maybe filing an MAA last quater.
You seem to be implying that A2-73 can work in (I assume considerably) more patients than 20%. From what other than hearsay and wishful thinking do you get such claim and why would that contention make regulators more inclined to approve?
First Anavex will need to show that the trial results were statistically significant and clinically relevant. Many incl. Anavex claim so, but based on a number of assumptions that we have yet to see a regulator consider. That requires an application filed and validated, which we have yet to see. If the one primary and one secondary endpoint met with a < 0.025 p-value is in the SAP and the regulator is willing to pursue that, then that were more hopefully objective biomarker data can be useful in supporting some form of approval.
Way too much hand waving, cheering and believing in 83% chance of approval way too early imo. The price of $AVXL would be higher if more than few on he MB posters believed in an 83% chance of approval.
There is big difference between screening out patients for a trial vs. dropouts from a trial, but I guess you are just ducking and diving making up new arguments as you go.
We are yet to see any subgroup analysis, but we already know SIGMAR wt vs. variant makes a lot less difference that indicated by the P2a very small trial analysis.
What other factors will be confirmed, falsified or if any new ones pop up, we don't know yet! As I've been saying, its why we know Anavex are working on that and Missling have hinted he feels its exciting. Missling is always much more excited than he think investors are - the reason has been shown consistently by every presentation of data to date!
This investor needs to see hard core data proof and I'm not sure we will get that from the current trials.
So more that 4.5m to go is the last few hours on an option expiry. Certifiable!
I have a feeling that $AVXL will end on or near the low of the day on close!!!
Probs buy $AVXL for less than $6 next week, but I can wait probably almost to Feb'ish.
The FDA have not and should not have any issue with inclusion/exclusion criteria for a clinical trial, even if it means 70% of the patients population is screened out. For example selecting only patients with PET indication of plaque etc. That won't affect the statistical outcome of the trial since all patients, drug and placebo arm, will have a close matching baseline.
The wait is imo the hope of strengthening the overall findings incl. OLE results with correlations to biomarkers, including across the pool genes with altered expression associated with PD and AD (70% overlap). If these and Sigma-1 as well the other prespecified biomarkers are showing more normal levels after exposure to A2-73 it gives hope.
This will likely take a while, as before, to process from the OLE and to then to run the many correlations across the trial entire dataset. If those objective markers show clear correlation to the top level results Anavex is trying to claim from completers only it could potentially provide enough evidence for EMA to provide a conditional approval and likely with a label targeting responders.
I would assume this is also a key part to the long awaited peer reviewed paper - have they filed one yet?
I know - let’s see how it goes. Anavex will need more supportive correlating data. They are working on it and delaying the MAA filing either because the CMPH have told them more is needed or they are just taking longer…
They failed trials in main CNS diseases with their Sigma-1 agonist, so they try something else.
Since the P2b/3 was not successful per original endpoints and SAP as defined, Anavex needs anything and everything that can help to show plausible evidence that A2-73 has an effect in AD patients that outweigh the risks.
The alternative is to run a larger confirmatory P3 designed to iron out the titration issues, show a dose/effect relationship that isn’t just ChatGPT generated and perhaps enroll on certain subgroup criteria that we are yet to see data on (gene expression etc.) - you know the precision medicine thing.
For now it seems penny wise pound foolish Missling is stretching things out to see if he can wing it with EMA.
Yes but you see for the price to go up demand has to outstrip supply, which isn't happening despite all the assurances over the last number of years from Georgejll about that short squeeze being just around the corner.
No one is wanting to buy here. The longer we wait the sooner $AVXL will be cheaper - maybe until Feb'ish.
That is undoubtedly true and almost as much as the EMA would consider what say Georgejjl, Catdaddy, Ohsay and all their cousins might think.
Let's hope EMA is now using ChatGPT to handle their approval process analysis.
Even if I wanted to, your logic would be impossible execution and besides I’m staying to at least Feb’ish to see if TDG gets his finger out and files an MAA.
According to Eikon ownership reports that is correct, all Vanguard funds holding AVXL are Index Style funds.
Sold half at around $5’ish for about 50% profit looking to buy back lower awaiting NDA filing and like decision dates for Reproxalap.
Where might $AVXL be by Christmas with no MAA filing in sight?
You have found the most entertaining bio mb I know of and I suspect you may be able to contribute.
Just look at all the emojis.
lol! That kind of statement can be applied to absolutely anything with equal weight, which amounts to about nothing.
The chance of anyone being pay to post here is infinitely lower than the chance of A2-73 being approved even from current trials.
Awesome stuff, especially the last bit.
Got my 1st daughter staying for a while as she finds her feet in Denmark after relocating from the U.K.