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You are still neglecting that the Anavex results were not accounting for dropouts! The statistic methods for the mAB trials and pretty much any trial does. Did you read up on that?
Good to see you have now realised part of your initial error. This why on a message board like this exchanging information and experience can be useful.
No one happy here?
Couldn’t something similar be said about pretty much any post here.
WGT posters working hard to justify their investment?
Let’s hope your thoughts are similar come Christmas.
I will then say what I’ve said in another post today about what the MAA filing hold up likely is and the possible reason for it.
Do you want me to tell you the same answer once again?
Indeed and it could have been expected that tiny trials like the P2a AD, adult U.S. Rett trial and even the AVATAR and EXCELLENCE studies turned out to provide unreliable results.
12x, me and others estimated how many patients would be in the 10mg, 20mg 30mg and 50mg cohorts of the P2a AD trial. We did the same with the P2b/3 trial readout and concluded few would have been retained at 50mg and dropouts from 30mg clearly also happen. It was tricky to do, since Anavex has hidden the information in an incomplete word salad.
It is also clear that the P2a peer reviewed subgroup analysis conclusions do not match what we are told about the P2b/3 results and we are yet to see the peer reviewed subgroup details from that data.
Why does Missling continue the same misleading strategy of too small trials and generating unreliable results that ultimately will likely lead to further larger trials with better design.
Probably by year end or before closer to $4 than $8.
Is this the same Hoskuld we once knew?
I think you need to read and learn about the concepts involved, just as I told you earlier! EOM.
You mean like Anavex also said all endpoint met in Dec 2022 and beyond, only to recently finally admitting point blank that the co-primary ADL endpoint was not met, but "trended positive". I bet you still don't understand why Anavex used Odds Ratios for the Dec. 2022 readout and beyond and only recently replaced that with Completer Analysis.
if you want to be successful in biotech investing, now is good time to learn the concepts and not just believe in company headlines.
In the approved mAB trials dropouts were accounted for in the statistical analysis!
I can add that the delay in filing the MAA almost certainly is linked to the mRNA analysis that for some reason still is not completed/available according to Missling.
The outstanding work of correlating mRNA expressions of multiple genes, like was done for the Parkinson's results, is likely hoped to show clear objective evidence that dosed patients, and not placebo, see more normal expression levels after completing the trial and perhaps also before discontinuing on A2-73, mostly early, as those over 30% did versus 7% placebo.
With such objective markers in hand and perhaps in consultation with the CHMP, the chances of approval from Completer Analysis results could lead to some form of conditional or label restricted approval.
I already posted a link to an article that explains survivorship bias and how to account for missing data.
Find and read that and do your own research, you might learn something.
Once you have read and understood at least in outline those concepts, try to consider what such a large amount of missing data can do to the results of trial.
You should then understand why presenting completer analysis was a tempting and most likely only option Anavex had.
Around 20% chance likely lower is pretty good for high risk/return biotech play. I also believe Anavex have good chance of approvals with well designed confirmatory trials.
This is just how it works in biotech, so $AVXL fits my investment strategy. I respond to all the silly WGT statements here that ALL so far have proven wrong. Some just don’t want to listen or learn.
What is it with these why are you here questions? They just emphasise the lack of critical thinking going on here.
One thought: < 20% chance of EMA approval from the P2b/3 study, but I’d love to be 100% wrong!
The biggest advantage of filing with the EMA first is of course the now Boisian 90% Statistical certainty of approval based on having been invited to do so by the CHMP.
As has been asserted here, the EMA must have seen ALL the data and knows that the Anavex results of the P2b/3 trial is slam dunk. This is based of course on what, has only now some 7 months later been presented publicly, as results from completer analysis only.
The assumption that those over 30% of patients discontinuing, most of them in the first half of the study due TEAEs, would have done brilliantly against placebo if only they hadn’t got too dizzy is completely acceptable to the CHMP. There is simply no need to take into account survivorship bias, which the EMA obviously must consider old hat statistics and completely unnecessary because they also evidently hate the mABs.
WGT and the FDA will have to arrange a crow’s dinner with their BP friends!!!
They and their investors just come with a WGT way of presenting it 😉
Yah but $AVXL might still be closer to being a $4 than a $8 stock.
Well the point though remains that Anavex still have some issues to resolve, which they probably can through another larger well designed AD P3 trial.
It is a ridiculously flawed implementation of short selling, which otherwise is and should be representing an opposite investment thesis!
Still that isn't the biggest problem Anavex or her investors have.
But the market hears is differently
You should submit your evidence of artificial supply vs. real supply to SEC.
The company have said and keeping saying many things that either never happens or are incorrect. Like say all endpoints met!
Here is a clear example of a great clinical outcome PR from this morning in one of my other US holdings: https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-achieves-primary-endpoint-phase-3-dry-eye
Will the dry eye confirmatory P3 trial prove successful this morning? Hard to call, but leaning towards yes.
Froll knows his stuff, but has been wrong before eg. on BTD for AD and Rett.
99% of posters here ended up being wrong on the Rett outcome.
Stat sig, except for the ADL co-primary endpoint, and then based on completer analysis.
Completer analysis that excludes about 1/3rd of the original trial population from the calculations is no longer a controlled randomised trial per defined protocol.
The survivorship bias introduced in this way is not ordinarily accepted as a basis for approvals, so imo an MAA filing for the P2b/3 AD trial is much more likely to land in the not approved bucket of the EMA stats touted here. Even more so that I previously have expressed, down from <50% to <20%.
Only more time will tell. Meanwhile hope seems eternal and if then approved would be fantastic.
That might be the case, but since the results presented appears to be based on completer analysis we still have no solid proof of efficacy for A2-73 in AD just as we haven’t in Rett.
That is where things stand, unless perhaps with imo only a small chance the EMA decides to grant some form of approval and demand a confirmatory trial.
Only time, and of course Georgejjl and Falconer, will tell.
The irony in my post that some folks here fail to see is telling of why biotech investing is not for everyone and how the infectious conspiracy virus epidemic has taken hold.
Billions of RNA based covid vaccine doses have been administered with very low percentages of TEAE and SAEs (mostly fractions of a percent by type of AE) vs. benefits from one of if not the largest databases across pretty much all ethnicities with safety and efficacy data in the history of medicine.
But alas A2-73 that has been tested in very few people and, as it turns out in the case of the P2b/3 AD study, effectively only in white skinned Caucasian people had in comparison over 30% TEAEs causing discontinuation from the trial.
Not getting that, in fact quite seriously meant, sarcasm in my post and taking it as I’ve changed my stance or whatever is a staggering reminder that biotech investing really isn’t for everyone.
I’ve never been as excited as Missling says Anavex are.
A2-73 / blarcamesine has just proven much more dangerous than the RNA based vaccines, with over 30% dropouts due to TEAEs - horrible stuff causing dizziness, falls and all sorts. $AVXL should be in the $2's by now and Missling in the slammer for causing so much harm to frail old people - just despicable!
NWBO - maybe that's why our chief cabal hunter and BSIG head has been remarkably quiet for a while. Like since Oct 2023? Anyone heard from the straight shooting bottom and especially top selling super fireman trader?
Yeah but will it hold $4 just as well as it held $8 last time?
Does that mean...
You would have thought Bigfoot was found long ago, but still I'm convinced he, she, it is out there hiding in plain sight - maybe even stealing our precious $AVXL shares from under our noses.
Deflection? What is your definition of "true supply and demand"?
As I have replied many times over the years here, even if I wanted to my Danish broker only provide derivatives trading, and for that matter shorting ,for scandinavian listed equities and my UK SIPP does not provide derivatives or shorting at all. You are just imaging that everyone is out to pee on your pet stock when they don't fully support the WGT thesis.
What the heck is your definition of "true supply and demand"? I can't help reading that as demand and supply between the True WGT crowd. Those that this MB's moral enforcement police accepts as true and approved staunch $AVXL long term holder, but happy to hear a clear definition.
Is day or swing trading etc. then manipulation, since these market participants might never have read or considered any information about what Anavex is trying to achieve and how they go about it or not - they just trade on intuition or wave about some TA stuff.
There is a group of folks here who has got a cabal conspiracy theory stuck in their Mitochondria and don't have enough Autophagy going on the get it cleared. To be clear I am not saying there is no manipulation in the financial markets, because there very evidently is, just as there is fraud on the market committed by e.g. biotech companies that damages their investors.
Think of it as a spectrum, where in one end there is almost pure volatility because the stock is difficult to accurately value based on available information not being all that clear leading to on average quite low liquidity (I often see that a few thousand $AVXL aren't available at the current offer price). In the other end of the spectrum are stocks clearly driven by news, positive or negative, with price acting and settling longer term at some price that corresponds to a sensible value estimate.
$AVXL is somewhere in the first half of that spectrum, because valuing it so far needs to bake in a risk/return balance, which isn't attractive at present because Anavex have established doubt about their catalyst announcements and the failed Rett programme with the outlook to more spend on clinical trials and uncertainty about the potential for approval out of current clinical trial results. This just begs for a volatile and relatively low liquidity stock.
Will the market ultimately have got it wrong? Not impossible, but for now to most of the market $AVXL just looks like another trade, with if you like amounts to no real supply or demand.
Should I buy back now or just wait until it no longer looks like the MAA will be filed in Q4 and the undisclosed / New Rare Disease trial enters 2025 without being revealed for the, is it 3rd or 4th year running?
Ah yes that’s right forgot, it’s all unfair because $AVXL is being manipulated despite Missling always being quite on point with his ‘catalysts’ and no Anavex trial has ever failed.