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It is Friday. So a maybe drop to the low $6 ? I have in a couple Stink bids. They are strictly for additional accumulation. I would NOT want to be OUT as sooner or later we will go UP and I don't mean a couple dollars of UP. It might be today or it might be close to the end of the year.
GLTAL's
John k9uwa
"peer release we will takeoff" Or the words All is Filed with EMA. Or better yet we have passed "Clock Stop 1"
I noticed this morning that VRNA Verona Pharma plc is now 94% TUTE OWNED. Anavex held at 33%. Those are end of
June 2nd qtr numbers. 🏁 🏁 🏁 The Checkered Flag is within sight.
John k9uwa
"clear choice for the EMA" Would you rather have nothing?
I would perhaps like to have it as a PREVENTATIVE!!
The Question is WHEN not IF will they approve 2-73
John k9uwa
Volume sucks 368,403 and looks like 60K of that was MOC orders.
John k9uwa
At 9:49AM bid 6.10 x 300 shares Ask 6.15 x 1100 shares Volume 23.31K
down 2.71% -17 cents
Someone wanted to make it look like down down down day? Would a MM do that?
sure strange it is.
John k9uwa
Unless someone posted an Ask and then from another account placed a Bid for same amount. Really strange. Then again for another 10 shares. The bid shows $6.09 x 100 shares.
John k9uwa
couple months"---OR MORE! You could well be correct. As to Feb'ish. I would like to hear Maybe as late as November WE have FILED all for EMA. And by Feb'ish I would like to hear. We have passed Clock Stop 1.
No bites on my stink bids today. Had one in at $5.94 and another in at $5.82. No Bites on either today. I did get a few shares back on the 16th at $5.95.
John k9uwa
Me a bit later to I hub Dec 2016. A bunch of us into AVXL prior to R Split. As to the price beats me but without some real news I don't see us having any large change of price. And who knows when that might happen. Anything from a day or so to a couple months.
John k9uwa
I have a couple Stink Bids as Tom would say... just in case we drop below 6.
Someone asked a couple days ago as to WHEN some of our members became owners
of Anavex Stock. Try This. Click on the name of someone your interested in finding out WHEN they became involved with AVXL. After clicking on the Name.. next click on Boards they have posted to. Next Click on the NUMBER OR POSTS to this board. Up comes the history of all our posts. Drop to bottom and click on LAST page. Then read some of our history. Earlier than that several of us were on the olden days Yahoo board and migrated to I-Hub.
John k9uwa
bought some Leo $5.95 pps.
John k9uwa
Same here Leo. Now playing with all house money. Plus from house money back in '21 I bought another rental house.
John k9uwa
HOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOLDING I AM
🏁🏁🏁 Checkered Flag in sight
John k9uwa
Dah / Dit / Dit Dit Dit / Dah
RRR
John k9uwa
"test" you passed the test. Sorry couldn't resist.
John k9uwa
Call it what you want repetitive etc. IT WORKS.
John k9uwa
Pretty close to one of Tom's points. Something about him grabbing more trade shares. I also might do the same.
John k9uwa
Yes no problem Leo. Thinking net loss from 38% or whatever it was last qtr to 33% for 2nd qtr. Maybe get to a point for re-entry? No real news and we may well continue to fall.
and Doc good chance that State Street sold at a profit?
John k9uwa
I only posted the Vanguard as it had an early posting of required 13F form and an increase in quantity of shares above Q1 number.
Try this one. They filed their 13F today for June 30th 2024.
TWO SIGMA ADVISERS, LP 633,000 added 584,500 entry to AVXL Q1 2022 Avg PPS 4.39 2024-08-14
TWO SIGMA INVESTMENTS, LP 1,012,883 added 477,336 entry to AVXL Q1 2022 Avg PPS 5.56 13F 2024-08-14
TWO Sigma Investments is based out of New York and is run by John Overdeck and David Siegel. TWO Sigma Investments is a hedge fund with 17 clients and discretionary assets under management (AUM) of $83,955,729,097 (Form ADV from 2024-04-26). Their last reported 13F filing for Q2 2024 included $43,901,317,697 in managed 13F securities and a top 10 holdings concentration of 9.28%.
STATE OF WISCONSIN INVESTMENT BOARD They had 58,008 shares as of Mar 30th. Sold ALL now they own ZERO shares. They first bought shares Q3 of 2022.
So far TODAY 24 firms have filed their 13F forms. So Far 147 firms have filed their June 30th 2024 13F forms. Probably only about 25 yet to file by deadline 15 August.
John k9uwa
Your list of funds holding AVXL adds up to 4,996,189 shares. I am guessing that those are current numbers as of yesterday? Compare that number to
Vanguard filed 13F 2nd Qtr ending June 30 2024 showing 4,548,219 shares. So this says Vanguard has purchased an additional 447,970 shares between July 1st and yesterday when you looked up the shares they have in various index funds.
LLY is 83% institutional ownership
WELL is 97% institutional ownership high end assisted living and medical facilities REIT
MRK is 79% institutional ownership
DHI that is DR Horton major home builder 92% of the float Institutional Ownership
BIIB is 92% institutional ownership
PFE is 68% institutional ownership
VRNA is 92% institutional ownership
As of end of 2023 4th Qtr Anavex was 25% Tute owned. as of March 30th 2024 end of Q1 we were 37% tute owned. Many of the 190 companies who own Anavex are not index. Yes many of them are index. Many Index Funds the mgmt has some discretion in what they buy or sell. Eventually all successful companies end up being majority owned by the Tutes. All of the Tutes have much better advisors than we the retail stock buyers. Paying attention to what the tutes are buying or selling is one way us retail types can have considerable gains of our investments. Plus of course groups of individuals in I-Hub.
John k9uwa
Vanguard has both index mutual funds and actively managed funds. The strategy of investing in multiple asset classes and among many securities in an attempt to lower overall investment risk. These investment products hold hundreds to thousands of stocks, bonds, and more.
Is Vanguard an actively managed fund?
Vanguard funds are better investments by design. We only launch products that have enduring investment merit, fulfill long-term client needs, and have a compelling advantage over competitors. As a result, 91% of our actively managed funds have outperformed the average returns of their peer groups over 10 years.
I saw one place where Vanguard has 100 Index Funds. This is of course in addition to their managed funds.
John k9uwa
Yes Vanguard Group INC added.
6/30/24 Vanguard added 133,537 shares 2nd qtr.
VANGUARD GROUP INC History 4,548,219 19,193,484 0.00% 0.00% 2596 133,537 5.37% Q4 2015 6.78 13F Filing 2024-06-30 2024-08-13
They have been in AVXL since Q4 of 2015. Their Average price is $7.78 pps 13F filed today.
John k9uwa
Hope everyone is buckled in and enjoying the ride. I Am Wishing I had put another zero onto my purchase on this one.
Thanks U and Guzzie
John k9uwa
Yes and no response. Thanks for trying.
John k9uwa
I also find it interesting to Re-Sort that list based on WHEN these companies first bought into Anavex. Just click on the 1st qtr column and see how many of
the 193 companies bought in at what year and quarter.
https://whalewisdom.com/stock/avxl
ReSorted the list alphabetical order. Some will show as Calls, Puts, Long positions.
SUSQUEHANNA INTERNATIONAL GROUP, LLP being one of those all three listings. Current end of June Long 302,060, Calls 349,300,
Puts 260,800
All interesting information.
John k9uwa
Sorry Leo I don't follow enough to have an opinion. Sometimes I might watch a game or two. Sometimes I watch Purdue play. And
sometimes we watch the Chief's games. The other half being from Missouri.
John k9uwa
"He’s a genius. That place prints money"
RENAISSANCE TECHNOLOGIES LLC History 466,437 1,968,364 0.00% 0.00% 1896 386,537 0.55% Q1 2024 4.59 13F Filing 2024-06-30 2024-08-09
Renaissance first bought into AVXL during Q1 of 2024 a total of 79,900 shares. During the 2nd QTR of 2024 they bought additional 386,537 shares. The $4.59 above is their average cost per share. They filed the 13F on 08-09-2024.
Geode has be IN Anavex since 2015. Add they added during 2nd qtr. These companies are PRO's. Well worth the time to look and see if these pro's are adding subtracting etc.
John k9uwa
They ARE Retail. Looked at that Renaissance Technologies. Looked them up. They have AUM: US$130 billion that was as of 2021.
Previous had 80K shares. They bought during 2nd qtr additional 306K shares total now 466K Claim to be a Hedge Fund also appears they play the Long Game
as well as maybe the short game. Definitely they have gone LONG on Anavex. Leo like me and probably many others have played and done Quite Well over
time. Will be interesting on Aug 15th when all of them must file their 13 forms.
If we get back anyplace close to that $5.50 mark I'll be buying additional shares.
John k9uwa
signs of "black hole" fatigue. For me 15 years not about to quit now. Due to trade about the core position I am much farther ahead
than the total of what I currently have in shares. No I don't think it will go to zero and yes I think the checkered flag is ahead. I see that the moderators
took the Checkered Flag out of our emoji list. As to the WHEN beats me. Anything from Oct or into 2025 is my guess.
John k9uwa
I could see a split Novo Norodisk in EU and their area and another Company in US Maybe NA / SA. Novo looks like it has done
quite well last 10 years or so.
John k9uwa
Ready for partner! I vote for Merck !!
John k9uwa
A few Firms have their forms 13 filed a bit early. Required date to be Aug 15th 45 days after end a 2nd qtr Some of those who filed a few days early/
Geode now has 1.831M shares up 118K from 1st qtr
PNC had 23K added 16K total 39K
Renaissance Technology Previous had 80K shares bought during 2nd qtr 306K shares total now 466K shares
NY Mellon had 240K picked up additional 40K shares
Nuveen Asset had 255K added 38k
Source WhaleWIsdom https://whalewisdom.com/stock/avxl
Sort by last Column Date Filed.
The others will appear over this next week. Required to be filed by 08-15-2024. By then we will know how many shares
have been pried out of hands of retail.
John k9uwa
Traffic in Miami is light except for Go To and Go Home from Work. For REAL traffic in Miami you should be there Jan, Feb, March. It starts picking up in late October and isn't done until end of April. They call them "Snowbirds" Looks like we are level so far in afterhours.
John k9uwa
"Donnenamab 3brain bleed deaths directly related 2drug" So give me the pill at bedtime. I'll sleep better and won't wake up with dizziness. And I darned sure won't get Brain Bleed.
Nidan if the company were lying to us the law suits would instantly abound. Vs some dizzy babe on Seeking Alpo trying to make a few nickels and get followers. I'll take the companies word for it every time.
Hosai I see nothing to stop us from approval by EMA. Yes the time to get it all processed through their system. I have waited 9 years no big deal to wait another few months. And YES If Anavex had screening like the MAB's did our results would be even better than they were with little screening.
Hoskuld ADL is irrelevant, as has been stated many times. The focus on this alone reveals the bias of the author. The tau, AB, brain volume, and cognition data were outstandingly good. 2-73 should be part of any AD treatment regimen - and I think it will be. Cure? No. New standard of care? Yes. And if something else comes along then it will still be part of the regimen.
I am 1000% in agreement with your statement!!
williamssc Anavex first to approval has some worried. Leaders get the arrows.
and the MAB's get the Arrows. You wouldn't get me to take any of them.
🏁🏁 The Checkered Flag is in sight GO FOR IT NOW. 🏁🏁
John k9uwa
That pretty well ends any chance that AH LEFT had at lawsuit against Anavex. Even better would be tomorrow to see the same against Adam Fartstain.
John k9uwa
After reading it myself my opinion is.. She doesn't know what she is doing. No mention that in May
our FDA posted the latest updates to WHAT they want and what to submit to FDA. Yes that was the last draft
version.
But then she writes for Seeking ALPO what would you expect?
John k9uwa
Words but can't get the pictures/charts etc.
Anavex: An Update To Their Phase 2b/3 Alzheimer's Trial Data
Jul. 30, 2024 7:16 PM ETAnavex Life Sciences Corp. (AVXL) Stock1 Comment
C. C. Abbott profile picture
C. C. Abbott
3.81K Followers
(15min)
Summary
On Sunday, July 28th, Anavex Life Sciences announced that data from their phase 2b/3 Alzheimer's Disease trial was presented at the 2024 Alzheimer's Association International Conference.
New data can be found in the announcement and the corresponding slide presentation.
I take a close look at the data and share my thoughts.
Firing Neurons
koto_feja/E+ via Getty Images
On Sunday, July 28, Anavex Life Sciences (NASDAQ:AVXL) announced that the results from their phase 2b/3 Alzheimer's Disease (AD) trial were presented at the 2024 Alzheimer's Association International Conference (AAIC).
I have previously covered AVXL's p2b/3 AD trial data as the company disclosed them. In this article, I'll provide an update, as there is new data being disclosed.
Before we dive into the data closely, the table below lists the headline and the sub-headlines from the July 28 PR:
Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at The Alzheimer's Association Conference
Oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with a good comparative safety profile and no associated neuroimaging adverse events.
Clinical benefit of blarcamesine consistently observed for both 30 mg and 50 mg treatment groups.
Benefits of blarcamesine on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease.
EMA submission expected in Q4.
I'll comment on the sub-headlines in the Discussion section below.
Let us now turn to the actual data, as disclosed by the company in their AAIC presentation slides.
Efficacy data: Co-primary, and key secondary endpoint
According to the company, this trial has two co-primary endpoints (ADAS-Cog 13, ADCS-ADL), one key secondary (CDR-SB) and one exploratory (CGI-I) efficacy endpoint.
Previously, the company stated* that the statistical-significance for the two co-primary endpoints were either both p<0.05 or one co-primary endpoint, plus the key secondary endpoint each has a p<0.025.
*On this topic, the company seems to have pivoted to a different view, i.e. "a sole cognitive measure can serve as the primary endpoint for early Alzheimer's trials."
The results of these endpoints are shown in slide 13 to 16 (see below).
Please note that the color, e.g. red, blue etc., boxes in the slides shown below are added by me for emphasis.
Co-primary endpoint data: ADAS-Cog 13 & ADCS-ADL
a slide
Slide 13 (AVXL 2024 AAIC presentation)
a slide
Slide 14 (AVXL 2024 AAIC presentation)
There are a few things to note here:
For ADCS-ADL, both 30 mg (p=0.354) & 50 mg (p=0.527) treatment groups did not show any statistically significant improvement over the placebo at 48 weeks, as shown on slide 14 above.
For ADAS-Cog 13, if p<0.025 is still the criteria, per AVXL's prior statement, then the 30 mg treatment group just missed the statistical-significance (p=0.026).
It's notable that the patient numbers at 48 weeks in these two measurements are not identical, and the % of patients (48 weeks/0 week) is highest in the placebo group (74-77%) and the lowest in 50 mg group (58-59%) (see table below).
Week 0
for both co-primary endpoints
patient number
Week 48
for ADAS-Cog 13
patient number at 48 weeks
(% of week 0 patient number)
Week 48
for ADCS-ADL
patient number at 48 weeks
(% of week 0 patient number)
30 mg 154 108 (70%) 109 (70%)
50 mg 144 83 (58%) 85 (59%)
placebo 164 122 (74%) 126 (77%)
(complied by author from slide 13 & 14)
Key secondary endpoint: CDR-SB
a slide
Slide 15 (AVXL AAIC 2024 presentation)
As mentioned before, if AVXL's prior statement pre statistical-significance of p<0.025 is still valid, then in the CDR-SB, 50 mg treatment group did not meet the statistical-significance (p=0.045).
Regarding the patient numbers, at week 48, for CDR-SB, the placebo has the highest number & percentage (77%) of patients completing, and the 50 mg treatment group the lowest (58%) (see below).
Week 0
patient number
Week 48
for CDR-SB
patient number at 48 weeks
(% of week 0 patient number)
30 mg 154 107 (70%)
50 mg 144 84 (58%)
placebo 164 126 (77%)
(complied by author from slide 13 & 14)
I note that for these measurements, the treatment groups' patient numbers at week 48 are not identical, from one endpoint to the next, e.g. for 30 mg group, n=108 in ADAS-Cog 13, n=109 in ADCS-ADL and n=107 in CDR-SB. The same is true for 50 mg group.
It's not clear, at least to me, whether the discrepancy is due to typos, or some patients' data has been selectively excluded in different endpoint analysis.
Biomarker data
According to the PR:
The [efficacy] findings are supported by biomarkers from the A/T/N spectrum, including plasma Aß42/40-ratio and reduction of brain atrophy.
More details can be found in the presentation, from slide 18-21 (see below).
Please note that the color boxes are added by me for emphasis.
a slide
Slide 18 (AVXL 2024 AAIC presentation)
a slide
Slide 19 (AVXL 2024 AAIC presentation)
a slide
Slide 20 (AVXL 2024 AAIC presentation)
a slide
Slide 21 (AVXL 2024 AAIC presentation)
For the biomarker data, I note that only in the so-called "Brain Atrophy" (slide 18) and "Plasma Amyloid Beta 42/40" (slide 19), there are any statistically-significant [beneficial] differences observed, but not in plasma Nf-L (slide 20) nor plasma p-Tau (slide 21).
I also note that for slide 18, only 55-56% (or 165-166 out of 298) pooled treatment group and 61% (100 out of 164) placebo group data are being reported.
For slide 19, the percentage is even lower [than slide 18], i.e. 40% (119/298) from the pooled treatment group, and 48% (78/164) from the placebo group's data is reported.
As for slide 20 and 21, there are no two patient numbers alike.
In summary, I'm unsure how meaningful or reliable these biomarker data can be interpreted, when the company seems to be selectively including or excluding patients' data, without any explanation.
Safety data
According to the PR:
Oral, once daily blarcamesine...[showed] good comparative safety profile and no associated neuroimaging adverse events
The details of the safety data can be seen in slide 22 (see below).
a slide
Slide 22 (AVXL 2024 AAIC presentation)
(Red boxes added for emphasis)
The table below reproduces the highlighted parts of the results of the table above in slide 22.
Adverse Events Summary 30 mg 50 mg Placebo
Patients, n 167 168 168
TEAE leading to treatment and study discontinuation, n (%)
40
(24.0)
63
(35.7*)
12
(7.1)
Treatment titration AE ≥5%, n (%) 167 168 168
Dizziness
53
(31.7)
67
(39.9)
10
(6.0)
Confusional state
24
(14.4)
24
(14.3)
1
(0.6)
Treatment maintenance AE ≥5%, n (%) 148 153 161
Dizziness
28
(17.7*)
48
(31.4)
10
(6.0)
Confusional state 16 (10.1*) 24 (15.7)
4 (2.4*)
*These data points seem to have typos or are erroneous, e.g. TEAE leading to discontinuation-50 mg, the % data given as "35.7"* should be 37.5=(63/168)x100%; or in Dizziness at 30 mg-maintenance period, the % data should be 18.9% (28/148)x 100% [not 17.7*% as reported].
To me, these double-digit % differences in TEAE [Treatment Emergent Adverse Event], between treatment groups vs. placebo, which are reported in the "TEAE leading to treatment and study discontinuation" as well as in "Dizziness" and "Confusional state" are negative and noteworthy, especially when the latter two persisted in the treatment maintenance period.
In terms of "TEAE leading to treatment and study discontinuation", the company offered further explanation on slide 23 and 24 (see below).
Summary: Safety Population
• TEAEs tend to occur in first 24 weeks and related to titration schedule
• AEs including dizziness:
• Mostly Grade 1 or 2 (mild)
• Transient (approx. 7-11 days)
• Manageable by adjusting titration and dosing time
(Slide 23; bold emphasis added)
• Early discontinuations due to TEAE (BLUE) before Week 24 might be related to up-titration of blarcamesine to the target doses coupled with administration early in the morning
• These events can be addressed by adjusting titration schedule to slower titration and nighttime dosing, as has been positively observed in the blarcamesine compassionate use program
• The low dropouts for non-TEAE reasons, ‘Other’ (yellow) are consistent across blarcamesine and placebo groups, which suggests that there are no dropouts due to lack of efficacy in the blarcamesine group
• There is no evidence that early discontinuations introduced a bias in favor of blarcamesine.
a chart
AVXL 2024 AAIC presentation
(Slide 24; bold added for emphasis)
According to these explanations, the company claims that "TEAEs tend to occur in the first 24 weeks" and "can be addressed by adjusting the titration schedule to slower titration and nighttime dosing".
The company also claims that "The low dropouts for non-TEAE reasons, ‘Other’ (yellow)...suggests that there are no dropouts due to lack of efficacy in the blarcamesine group".
The former is not impossible, although unlikely in my opinion, judging by the fact that the TEAE data were similar in both periods, with even some new items being observed in the maintenance period, e.g. Urinary Tract Infection, Fall, Depression and Disorientation.
As for the latter, in my opinion, the opposite [to the company's suggestion] is more likely to be true, namely the similar [low] dropout rates due to other [than TEAE] reasons that suggest that a similar effect or the lack of it were experienced by the patients in all three groups.
Early AD Endpoints guidance
In the PR, the company claims that:
As specified in the March 2024 FDA Guidance for Early AD, a sole cognitive measure can serve as the primary endpoint for early Alzheimer’s trials...
The prespecified key secondary composite endpoint CDR-SB, also recommended as an alternative primary endpoint for early AD in the new FDA guidance
For any reader who is interested in AVXL's AD program, I highly encourage them to check out this FDA document for themselves.
The reason for this is, that, in my opinion, one would come away with totally different conclusions than what was claimed or implied by the company.
For example, in the March 2024 FDA guidance, one does not find any statement stating "a sole cognitive measure can serve as the primary endpoint for early AD trials", nor does it recommend using "CDR-SB as an alternative primary endpoint for early AD" anywhere.
In fact, this document lists none of the measurement endpoints used in AVXL's AD trial specifically, e.g. ADAS-Cog, ADCS-ADL, or CDR-SB.
The extracts below are some statements which, in my opinion, are relevant to the FDA's guidance on early AD.
Historically, studies to support approval for drugs in the overt dementia stages of AD (Stages 4 through 6) have used an approach, which required the assessment of both cognitive and functional (or global) measures as co-primary endpoints (page 4).
FDA may consider other approaches, including endpoints based on cognitive assessments or surrogate endpoints, which may allow for shorter trial durations as a basis for approval in the earliest stages of AD (i.e., Stages 1, 2, and early 3) (page 5).
Sponsors considering these issues [endpoints for stage 1 AD] should meet with FDA early in development, to discuss the evidence that would be needed to support a marketing application (page 7).
(Bold added for emphasis by author)
If I recall correctly, AVXL has yet to meet with the FDA to discuss their AD program in general or this AD p2b/3 data in particular.
Perhaps this [have yet to meet/discuss with the FDA about the endpoints] is the reason why the company plans to file an application only to EMA and not the FDA in Q4 2024.
Financials
According to AVXL's Q2 2024 report (on page 8), the company has a cash runway of $139M, and a 6-months net loss of $19.2M (or a quarterly net loss of $9.6M), as of March 31, 2024.
Per AVXL, the operation is funded for 4 years (slide 5).
a chart
Page 8 (AVXL Q2 2024 report)
On Monday, July 29, the company filed a prospectus for the sale of their stock to raise an additional $150M.
Discussion
Firstly, according to the company's prior PR concerning the statistical significance of co-primary endpoints, either both p<0.05 or one co-primary endpoint, plus the key secondary endpoint each has a p<0.025. By this standard, the present co-primary endpoints data is mixed and inconsistent or failed.
Namely, in ADCS-ADL, both treatment groups (30 mg & 50 mg) failed to reach a statistical significance (p>0.05); in ADAS-Cog 13, only the 50 mg group is successful (p<0.025); in CDR-SB, only the 30 mg group is successful (p<0.025).
Secondly, biomarker data also seems to be mixed and inconsistent or failed, reporting far fewer [than for the efficacy endpoint] patients' data, and with patient numbers (reported) varying widely in different biomarkers for no apparent justification or reason.
Thirdly, on the safety data, I find the double-digit % differences between treatment groups vs. placebo in TEAE related discontinuation rate; for "Dizziness"; and for "Confusional state" troubling.
I disagree with the company's views that these safety concerns can be addressed by a slower titration schedule, or by evening dosing.
I also disagree with the company's view that low/similar dropout rates in the maintenance period for other [than TEAE] reasons, across all three groups, suggest that they are not due to the drug's lack of efficacy.
In my opinion, the low/similar drop-out rates across all three groups for other [than TEAE] reasons in the maintenance period reasons, do suggest the drug's lack of efficacy.
In other words, patients who were in the treatment groups were not more inclined [than the placebo group] because of the treatment effect, to continue in the trial, even if they could tolerate the treatment.
Conclusion
In my previous article, I stated that I've sold my AVXL stake, exited the AD space altogether as an investor and gave the stock a HOLD rating.
After looking at/analyzing the data for this article, I think I'll continue to stay away from the AD space in general, from AVXL in particular, and will revise my rating to a SELL.
The change of rating is due to the reasons mentioned above, e.g. the efficacy data is mixed/inconsistent, the biomarker data is mixed and problematic due to selected reporting, and safety data are negative or less positive than the company is claiming or suggesting, in my opinion.
I find it doubtful that these mixed, inconsistent or failed data will be strong enough to support a filing in early AD, let alone to secure an approval, wherever AVXL ends up filing their application.
To the best of my knowledge, AVXL has not filed for any other indication (slide 14), e.g. Rett syndrome, Parkinson's Disease anywhere, besides the current guidance of planning to file with the EMA in Q4 2024 for early AD.
The above can account for my bearishness for AVXL's near-term prospect.
As for its long-term prospects as an investment opportunity, I'm bearish still. Why? Readers may wonder, if the company seems determined to continue.
My answer: As an investor, I'm unable to trust the management at their words, e.g. their claims regarding what the FDA guidance says about the required endpoint data in early AD vs. my own understanding of the document.
In my opinion, this [being unable to trust the management at their words] is not just a red-flag, or weakness/setback in the R&D process which is common or unavoidable, but a deal-breaker for anyone whose investment thesis is based on the fundamentals and not on opportunistic trading.
Risks
Risks here includes but are not limited to; irrational market response to the upside for macro or company-specific reasons, if/when the FDA agrees with AVXL pre the filing with the current data, if/when AVXL successfully file with the EMA and if/when such a filing results in an approval, and if/when AVXL reports positive material news or trial results etc.
Thanks for reading. Hope that this article is clear and helpful to your research.
This article was written by
C. C. Abbott
John k9uwa
"Lest ye forget, I also exited @ 7.30 yesterday."
I Bought more shares earlier $6.34 today and then into afterhours bought more at $6.28. So LEO both of us todays purchase about even. However of course
I am hanging onto all the shares. Did you ever go back and count up the number of times you have done the $2 buck deal?
🏁🏁🏁 The Checkered Flag is within sight!! 🏁🏁🏁
John k9uwa
Skunk got filled @ 6.53 Result...I am upside down. For once I beat you a bit but did I really? Still holding ALL plus grabbed some more at $6.34. In time we will both be rewarded.
John k9uwa
Yes Fudsters Abound. Hired by the Short and Distort group.
John k9uwa
See MayoMobiles comments on FragileX on Stocktwits. Posted about 15 minutes ago.
https://stocktwits.com/MayoMobile/message/581114121
John k9uwa