Anavex Life Sciences Corporation (AVXL) Quote

It’s trading at 6.96 in an off hours market (Robinhood). Up .22.

Dropout was a little higher than expected by 48 weeks but was higher in the placebo group than in the 30mg group as a %.
Either way what is clear is the drug beat placebo in ADAS - COG and CDR SB with p values under 0.025, in brain volume reduction loss and in regards to plasma 42/40 and PTAU.
Worth reminding that this was with only around 10% screening in the original enrollment, unlike Donnenamab and Lecanumab who screened out 70-80%.

Bar, I guess they answer to their bosses
and they gotta be able to buy their
raman
noodles
this
week.

So let them make their 5.95 its all good!

FDA submission? Haven't seen anything about that. EMA? This year? I'll believe it when I see it.

I don’t think he is, in the sense that the results are encouraging for a new P3 trial designed to iron out the titration difficulties and with a larger n that includes ethnic diversity.

I can't tell without hearing his words at the presentation (especially whether an explanation for all the missing data was stated. He did not prepare the company slides.

"There they"--Both will eat their words !!!!! Losers !!!!

Thank you for the link. Yes, as expected, the safety cohort n is any patient receiving one dose (hence 335 pooled). The mITT would be the n on top of slide 11 (and used in the MMRM/LSM analysis), the numbers at 48 weeks for ADAS-Cog (slide 13) are the protocol completers (lots of dropout) and only add up to 191 out of the 335 entering the study and 299 who made it to the first follow up visit (cohort defined in slide 11).

MRI data not available in almost 1/2 the treated patients and biomarkers missing in 60% of patients, what's up with that. Kind of hard to support data with biomarkers if most patients were excluded.

Demographic slide shows placebo cohort was worse off than the treated groups --- in fact they started off 2 points worse on ADAS-Cog and 0.3 on CDR)

Ok understood the tactic of lowering expectations to avoid disappointment. You seem not have followed what’s been going on plans for EMA and FDA submissions lately. Catch them up!

Unfortunately Anavex clinical trial outcome news always raises questions, which is why the price of $AVXL tend to move opposite of WGT expectations.

This time is no different.

There they Are!!

"I’ll stick with my less than 50% EMA approval"--completely expected from Mr.Negative !!!!

“Anavex still playing games…”. Is Dr. Marwan Noel Sabbagh playing games as well?

I mean, I hope I'm wrong, but over the last 9 years, except on maybe two or three occasions, Anavex seems to drop anytime "good" news comes out.

Btw, if you are insinuating that I'm anything other than a hopeful for the success of this company, you should do a little research into my posts. I'm a converted realist (maybe even pessimist) as Anavex's share price always seems to disappoint on news.

TGD is hoping the third time's a charm. Same trial and 3 different results.

Yes the dropout rate in the first 24 weeks was huge in both drug arms, about 1/3.

Likely the results given are for completers only and if so pretty much invalidates approval chances. Although the plasma biomarker correlations look good.

The absolute reduction in brain atrophy is tiny and unlikely to have weighed much on clinical outcomes. MRI accuracy / sensitivity likely too low making those reduction figures unreliable.

Note also that we now know that eligible for the OLE was about 70% (including placebo).

I’ll stick with my less than 50% EMA approval and agree with your almost none for FDA approval given the near complete lack of ethnic diversity.

Sun set and roaches were crawling out I am told.

I will take the advice from renowned Dr. Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Scientific Advisory Board than a pretend doctor on an internet chat board.

In true Anavex fashion, under $6, maybe even below $5.

Here are the full AAIC presentation slides: https://www.anavex.com/_files/ugd/79bcf7_79c4b8754b9f4eaca6da3e912e11689b.pdf
There is only 108 out of 154 in the 30mg and 83 out of 144 in the 50mg cohort finished the trial, or used in the endpoint calculation. n changed.

And there it is!!

We have known (deductively) since early March that even back then the MAA filing could not likely be projected before September. So, back and forth with the rapporteurs has pushed the original projection back another month or more. Not unusual.

I just read the PR a minute ago. I still think the likelihood that AVXL files this year based on the single 2b/3 with either or both FDA and MAA is still 1-2 %.

From today's PR
For the primary endpoint ADAS-Cog13, blarcamesine is significantly better than placebo for both 50 mg (-2.149; P = 0.021) at 48 weeks and for 30 mg blarcamesine dosage groups (-1.934; P = 0.026) at 48 weeks. The key secondary endpoint CDR-SB was significantly improved vs. placebo in both 50 mg (-0.465; P = 0.045) and 30 mg (-0.502; P = 0.020) assigned dose groups.


From September 14, 2023
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease

Note the very strange result saying 50 mg progressed 2.1 points less on ADAS-Cog than placebo AND 30 mg progressed 1.9 points less with p values around 0.021-0.26. Yet in September 2023, for 30 mg plus 50 mg using more accepted MMRM/LSM, combined dose was 1.78 fewer points progression compared to placebo and p=0.026.

There is no positive value solution for (n1+n2)*1.78 = (n1)*2.1 + (n2)*1.9 So only answer is that different cohorts were used. My guess is the new data is only using completers.(PP cohort) which is not an acceptable method for regulatory agencies. That also explains the high dropout rates (for the MMRM/LSM the mITT cohort was probably the standard of all patients who received at least one dose and had at least one post baseline visit (i.e. 12-13 weeks).

Another clue that there were different cohorts is that the p values for 1/2 sized 30 vs 50 mg groups are the same as for the larger combined cohort, compared to placebo.

The PR was written for investors not scientists or clinicians

Anavex is still playing tricks with the stats.

Time to start adding the number of indications and their worth.

We are looking better than the SOC.

We got some meaningful numbers.

We got the Anavex timeline for EMA, Q4 2024. So Febish Lol

Who cares, we looking better than the rest.

https://www.anavex.com/post/results-from-anavex-life-sciences-landmark-phase-iib-iii-trial-of-blarcamesine-presented-at-alzheime

We got the magnitudes.

I'll take it.

50%?

Still?

Cmon man.

This data was shared at the AAIC conference for the whole world to see.

Blarcamazine A2-73 = WINNER!!!!!💥💥💥💥

From Anavex website, posted about 5 PM: "Blarcamesine significantly slowed brain atrophy in key regions of interest, including the whole brain by 37.6%, total grey matter by 63.5%, and lateral ventricles by 25.1%.". So some numbers to go with the strong p-values...

@Doc328 @Investor2014 @frrol @kund Does the AD Phase 2b/3 full readout change your opinion on the EMA and NDA approval? Unless the AD OLE results are disastrous, Full regulatory submission of blarcamesine in Europe (EMA) is expected in Q4 2024. There was an 83% approval rate once submitted. FDA would be more challenging for the following reasons I see:
1. There is virtually no ethnic diversity in the trial. All white populations, nearly no representation from Black, Asian, Hispanic is a red flag for FDA and Asian countries to approve.
2. The dropout rate is too high. 335 patients dosed, only 191 completed. (107 in 30mg and 84 in 50mg cohort). 31% and 42% of 30mg and 50mg dropped out of the trial even with an Early Discontinuation statement. There is no evidence that early discontinuation introduced a bias in favor of blarcamesine How does one know the patients who dropped out would have worse than placebo ADAS-COG13 results?

Overall, it's a positive development as the dose dependency is somewhat confirmed. I see 12x the current price $80 which gives $6 Billion, about 1/3 of addressable EU AD market.

https://www.anavex.com/_files/ugd/79bcf7_79c4b8754b9f4eaca6da3e912e11689b.pdf

Fartstain and the other fudsters/naysayers will be out in full force until we get the peer review published. I hope it comes soon!

that sometimes good people win?

Tak!

The skeptics have asked whether the slowing of brain atrophy with Blarcamesine is really a meaningful amount. Now we have the numbers, and it is!

This is fantastic news. We are so happy. Several family members have AZ or Dementia. Please lord move this to the finish line. The naysayers will begin bashing again.

deleted

--EF Hutton Initiates Anavex Life Sciences at Buy With $46 Price Target

Any predictions out there for tomorrow's stock price?

I am so dissappointed.

Its been 5 minutes and the evisceration expected from AF and his droogies hasnt been posted yet.
Guess they are agreeing on their talking points.

As far as for longs..........

CONGRATULATIONS!!!!!!!!!!!

https://finance.yahoo.com/news/results-anavex-life-sciences-landmark-210000583.html

https://www.anavex.com/_files/ugd/79bcf7_79c4b8754b9f4eaca6da3e912e11689b.pdf

From Stock titan on Stocktwits--awesome !!!----https://www.stocktitan.net/news/AVXL/results-from-anavex-life-sciences-landmark-phase-i-ib-iii-trial-of-u3hpcferqhle.html

Posted by Goodhealth on Stocktwits----https://www.facebook.com/photo/?fbid=10164076524487571&set=gm.8608164295880123&idorvanity=1428015073895117

Cricket...another nothing burger conference is over.

Right!

Havent been here for a while, saw multitudes of acidic wry comments, and thought
someones scared!

Waiting for a press release hope somebody is there
to tell us of course the horrible news :)

The bashers, FUDsters and shorters are all very nervous.

AVXL NEWS coming soon!!!

Good luck and GOD bless,

regarding the website update, basically lipstick on a pig. No sense of improved communication of content.

They looked at how gene expression was impacted for 120 P2 patients...it was pretty comprehensive. I would expect the same findings - hope so, anyway.

NEWS seems to be month old, already occurred and is not the best definition of
meaningful communication out there.

According to Google it is now 3:23pm in Philadelphia.

WRONG!!!

Nice find, george ... so, when was this letter sent or posted on the website? How current/old is it? I have not seen it until now.