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CM lacks the courage to talk about failures.
Let’s ASSUME that all the information in the PR is absolutely accurate. Then what?
I’d say then it’s reasonably convincing for AA and/or even full approval — except for one addition issue: data on different dosage arms (note that the drug can only be approved for a specific dosage — so pooled analysis must not be sufficient).
In spite of all the missing information in the PR, the AD situation is certainly much better now than before.
Reduction is brain-size loss must be impressive (with very low p -value) — I wish we had the numbers.
Just noticed that the PR does say “significant”..
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A significant reduction in pathological amyloid beta levels in plasma1, as well as a significant slowing in the rate of pathological brain atrophy2 on MRI (Magnetic Resonance Imaging)3 scans.
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The biomarker data is CERTAINLY a very positive information. But incompleteness — raises many doubts (is the change clinically meaningful? Why aren’t they disclosing that information? What about other biomarkers?)
Also — flip-flop of cog etc — also comes across as shady, and perhaps raises other questions.
So — these are the problems in the data being approval worthy (or at least the market being skeptical of it). But certainly hope that an appropriate P3 can be designed with good chance of success perhaps??
If placebo’s Cog (mean) score goes from X to Y, then the decline is (X-Y).
If treatment’s decline is (A-B) then the percentage reduction in decline of treatment vs placebo would be:
(A-B) - (X-Y)
—————- x 100
(X-Y)
There may be an article.
But, that doesn’t justify an obviously incomplete PR (eg giving p values of biomarker changes without giving the actual mean values). No other reputed computed company does that. Eg look at how SAVA PR’ed their biomarker values.
Yes (to your key Q on cog scores).
Yes, I read all replies to me.
Bas!!
My messages are not for you — I have you on iggy, please do the same. We are at totally different levels.
You don’t need an AF to point out the flaws/strange-findings in this PR.
Mostly — it’s a lot of missing information, which kills the credibility of the reported analysis.
Overpromising is his least-objectionable fault.
The problem is that he LIES! ORs also turned out to the whole big BS after AUC.
EXCELLENCE results will have a whole new BS endpoint made-up.
You got no answers to Qs?
Why have the change values and p-vale’s changed from December?
Doesn’t seem fishy? At least, they are hiding something ..
Flip-flop and mess continues.
ORs abandoned.
Back to mean-change.
p-values and mean-delta of Cog values changed (from CTAD).
MINIMAL information revealed on biomarkers (only p values!) after 1.5 years!!
Do we expect EXCELLENCE PR to be different? Will be the biggest shock!!
You expected AVXL to change behavior in 9 months?
Issues.
1. Even if you buy their rationale (0.025 etc), they still aren’t revealing LSM of ADL change. I understand it’s not statistical sig. but why hide it.
2. Why the flip-flop from ORs to LSM now? Is CM accepting that he made a fool of a of us till now with ORs bulls%#€?
3. Where are the actual numbers (placebo and treatment) for the biomarkers??? CM hasn’t learnt yet how to do a PR? Unbelievable.
I’m guessing you are clueless even at your old age..
Agreed— AF is more about being able to influence the market rather than scientific credibility. Scientifically, he doesn’t know or understand “much” — but he is certainly able to see red/orange flags quite easily and points them out immediately. Yes, he could be wrong n his skepticism —- but that’s not a bad thing. In investments, it’s better to be more skeptical than needed.
Yes, AF has huge credibility in the market. About 8/10.
CM has near-zero — I’d say 1/10. Rightly so, IMO.
Yes, complete circus — and the frequent posters are, by definition then, jokers.
Really — there is nothing to talk about. CM is silent for 9 months (!) post a highly messed up (filled with mistakes and incompleteness) CTAD presentation and PR.
He has taken the fools (including me, I suppose) for a ride.
Infuriating!
A publicly traded company is for sale, by definition. As far as what is “enough” — only market (and not blindfolded dreamers) knows best.
Not obvious to you?
How about why they used RSBQ-AUC in Avatar, without ever disclosing mean-delta RSBQ — and then going back to mean-delta RSBQ for EXCELLENCE (for now) with the reason being “AUC is not required since the trial is large enough to offer statistical significance” (something like that).
It’s because they didn’t want to admit failure.
Used a mirror lately? YOU are the epitome of nothingness.
I’m in the WFU (big time!) camp.
Yes, there are always situations where low volume at bottom can mean:
Selling has stopped
Buyers are being cautious — waiting for the braver souls to buy first. Then, the stock rises slowly.
But — avxl has gone down to 7.5-8 multiple times … so to me, it doesn’t look good at all…
But technical analysis is only statistical or speculation. Plus, in long-term, technicals have zero significance. So doesn’t matter to me.
Hopefully, after a few years, you will be smarter too.
You are welcome. Some people here think — low volume at 8 is great since that means the sellers aren’t selling!! So always happy to enlighten (if that includes you too — you are welcome :)).
At the “bottom”, low volume is not a good sign — it says that buyers aren’t willing to buy even at such a low price. Sellers of course aren’t selling at low prices unless they panic.
At the “top”, low volume is a great sign (eg in a flag pattern) — therein it says that sellers aren’t selling even at high prices.
Overall — technically AVXL doesn’t look good. But, right now, it’s all about the pending news — which shockingly has taken 18 months post trial completion … which is a terrible sign. EXCELLENCE pr may take 6-12 months too for anything more meaningful than a repeat of the CTAD-like debacle.
Zero. Zero chance this will cross $15 in one year. Zero.
Fools love to dream.
13-14 months since completion of AD trial — which CM proclaimed as “met all co-primary end points!!’. And not an iota of progress (no fda discussions, no P3 plan, forget about NDA!), except for the most crappy CTAD presentation of trial-data in the history of biotech industry! It’s got to be a major major stigma on Stephan McFarlane’s CV.
Haha. Level of cluelessness and/or blindfolded is astounding!!
This was a P3 trial. Ignore definitions. Go to clinical trial website, type in "anavex 2-73" and choose Phase 3 as a criteria and up comes this study. It is no less a P3 just because it was also labeled P2b. Efficacy and safety are everything - and in this case both were best in class.
Sarepta PR’ed first results in June 2018, when it shot to $150 first time.
Then, it “failed” it’s P3 (functional endpoint/pivotal) trial in Jan 2020.
The restarted P3 trial will finish in a month.
AA is based on the “failed” 2020 trial and other biomarker/open-label/small trials.
So AA took 4.5 years. Full approval if the current trial succeeds will be in 6.5-7 years (note that part of the delay is due to a trial non-success).
It’s shocking how the AD opportunity has been squandered. If CM had the right sense — he would have had discussions with FDA by now, and already started P3!
I am not holding out any hope for any pivotal results from biomarker or otherwise — WGT crowd can continue to dream blindfolded.
It will be another year or two before P3/pivotal trial is started. Such a shame.
It’s all about potential Rett approval now — at CM’s pace, even that seems far away if at all …
I understand. It’s just that your guess for the delay is different than mine — and mine is based on the history of the company.
Speculative and optimistic. Which company takes 3+ months from “supposed availability” and 13+ months after trial completion to release pivotal data? Name a single one.
More likely — as in the past trials and data releases — he is just doing data engineering or the data is not significant at all (and he’s just planning to publish in a journal).
“Preparing for FDA” is a silly/imaginative reasoning — data release to public is typically done right away. In either case, “preparing” the data for FDA also — doesn’t take 3+ or 6-9 months!! Forget about it …
Yes, just saw the latest (May 2023) presentation on anavex.com. Nothing on it in terms of trial data -- except for the Odds Ratio BS from the recent AD trail (very contrived and difficult to understand -- almost like CM is trying to just fool the market). A successful trial's data can be very very cleanly presented.
What intrigued me further was the following line: "newly available preliminary efficacy results of surrogate biomarkers". If the results are already available in May 2023, WTF is he doing with them for THREE MONTHS?!! Amazing. But, that's Anavex's modus operandi anyway ...... it's foolish to expect anything different. Unbelievable what CM does!
Assume 6-9 months before release of top line results!!
I agree. Need to take your point seriously. Thanks.
That paragraph certainly has a lot of fluffy buzzwords to fool/charm the audience/market.
CM has done it before. Can never forgive him for AUC BS, and December 2022 scam/fraud.
Marks means well (and is a gem) — but the below words count for little (he doesn’t have the guts to go against his incompetent subordinates). Considering what happened with SRPT.
FDA Marks :"We’re going to be encouraging people in the direction of accelerated approval when they can, especially for rare diseases. Because for rare diseases, and especially things that are like neurodegenerative diseases,
Rett timeline, as per me.
Dec 2023: PRELIMINARY data.
Dec 2024: “Full” data (needed to initiate FDA discussion).
June 2025: FDA feedback.
Dec 2025: NDA
Sept 2026: Potential approval.
So, we are looking at 3 years.
You may disagree with the full-data delay, but for every single past trial — AVXL has done exactly that or worse.
All I want is CM not “sitting” on the data for months — doing “data engineering” (what else?). Be a man — and be transparent.