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Expect a short squeeze on AVXL stock SOON!!!
https://www.fool.com/investing/2023/02/09/this-short-squeeze-candidate-could-actually-pan-ou/
Good luck and GOD bless,
I am more certain than ever.
I am absolutely certain that Roche is interested in partnering with or buying Anavex Life Sciences or licensing Blarcamesine from Anavex.
I have heard and believe that JNJ and Pfizer among other big Pharma are also interested in Anavex Life Sciences.
Good luck and GOD bless,
Yes the hope is, including mine, that the EXCELLENCE readout is good and that the totality of data from all three Rett trials, along with the RWE of parents and advocacy groups, will swing in favour of approval.
The trofinetide FDA decision is due 23rd March and so far without advisory committee. That will give an insight to how low the bar is.
Bullshit! Missling unequivocally stated in the presentation and during the Q&A that the FDA requested AUC, because it's more rigorous and mitigates type 1 and type 2 errors. I know you think Missling is a liar, but true investors believe he speaks the truth about such things. FUDsters try to paint him as a liar.
Gee, I am impressed with your ironclad reasoning.
This horse was beaten to death back then, and your math adds up.
However it doesnt change the fact that we got a signal in some ADULTs with RETT, in a tiny tiny trial.
Hopefully even better signal in these kids.
There is a difference between believing evidence of FDA requesting AUC has been provided and showing unequivocally that it has.
It has been provided several times.
You are assuming that Missling agrees with your analysis and your inference is correct about the undisclosed AVATAR measurements. I am going by his public statements rather than your speculative posts.
The possibility exists that you are right -- since the record is silent on your issue -- but you have never been able to prove it, just argue it. A lot.
You see that is what happens when you provide 5% very insightful post and 95% FUD like posts.
Ever heard of the little girl that cried wolf?
It has been provided several times... go look it up!
Enough of this NONSENSE!
LOL. This is the most worthless observation to date. We have a winner.
Please provide the evidence of that FDA request.
You must be suggesting FDA "hanky panky", since they were the one requesting AUC for the small AVATAR trial
yes with the right news.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
Do you need to listen to the AVATAR conf-call again, to get it straight?
Did you even read my post and more importantly examine the clear evidence provided?
I know, you did not!
State Street just reported and they currently own 7.46% of the outstanding shares of Anavex. That would be approximately 5.8 million shares.
Will one day be wealthiest man on planet
Complete nonsense.
For all you know, moving from 84 to 92 could have tipped the balance.
Form SC 13G/A ANAVEX LIFE SCIENCES
Filed by: STATE STREET CORP
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
SCHEDULE 13G
UNDER THE SECURITIES EXCHANGE ACT OF 1934
AMEMDED FILING
ANAVEX LIFE SCIENCES CORP
(NAME OF ISSUER)
COMMON STOCK
(TITLE OF CLASS OF SECURITIES)
032797300
(CUSIP NUMBER)
12/31/2022
(DATE OF EVENT WHICH REQUIRES FILING OF THIS STATEMENT)
CHECK THE APPROPRIATE BOX TO DESIGNATE THE RULE PURSUANT TO WHICH THIS
SCHEDULE IS FILED:
(X) RULE 13D-1 (B)
( ) RULE 13D-1 (C)
( ) RULE 13D-1 (D)
*THE REMAINDER OF THIS COVER PAGE SHALL BE FILLED OUT FOR A
REPORTING PERSON`S INITIAL FILING ON THIS FORM WITH RESPECT TO THE
SUBJECT CLASS OF SECURITIES, AND FOR ANY SUBSEQUENT AMENDMENT
CONTAINING INFORMATION WHICH WOULD ALTER THE DISCLOSURES PROVIDED
IN A PRIOR COVER PAGE.
THE INFORMATION REQUIRED IN THE REMAINDER OF THIS COVER PAGE SHALL
NOT BE DEEMED TO BE "FILED" FOR THE PURPOSE OF SECTION 18 OF THE
SECURITIES EXCHANGE ACT OF 1934 ("ACT") OR OTHERWISE SUBJECT TO THE
LIABILITIES OF THAT SECTION OF THE ACT BUT SHALL BE SUBJECT TO ALL
OTHER PROVISIONS OF THE ACT (HOWEVER, SEE THE NOTES).
CUSIP NO: 032797300 13G PAGE 2 OF 7 PAGES
1. NAME OF REPORTING PERSON: STATE STREET CORPORATION
I.R.S. IDENTIFICATION NO. OF THE ABOVE PERSON: 04-2456637
2. CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
NOT APPLICABLE
3. SEC USE ONLY
4. CITIZENSHIP OR PLACE OF ORGANIZATION
BOSTON, MASSACHUSETTS
5. SOLE VOTING POWER
0 SHARES
6. SHARED VOTING POWER
5,680,194
7. SOLE DISPOSITIVE POWER
0 SHARES
8. SHARED DISPOSITIVE POWER
5,812,605
9. AGGREGATED AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
5,812,605
10. CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
NOT APPLICABLE
11. PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9
7.46%
12. TYPE OF REPORTING PERSON
HC
CUSIP NO: 032797300 13G PAGE 3 OF 7 PAGES
1. NAME OF REPORTING PERSON: SSGA FUNDS MANAGEMENT, INC.
I.R.S. IDENTIFICATION NO. OF THE ABOVE PERSON: 04-3555193
2. CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
NOT APPLICABLE
3. SEC USE ONLY
4. CITIZENSHIP OR PLACE OF ORGANIZATION
BOSTON, MASSACHUSETTS
5. SOLE VOTING POWER
0 SHARES
6. SHARED VOTING POWER
4,526,948
7. SOLE DISPOSITIVE POWER
0 SHARES
8. SHARED DISPOSITIVE POWER
4,542,248
9. AGGREGATED AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
4,542,248
10. CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
NOT APPLICABLE
11. PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9
5.83%
12. TYPE OF REPORTING PERSON
IA
CUSIP NO: 032797300 13G PAGE 4 OF 7 PAGES
ITEM 1.
(A) NAME OF ISSUER
ANAVEX LIFE SCIENCES CORP
(B) ADDRESS OF ISSUER`S PRINCIPAL EXECUTIVE OFFICES
51 WEST 52ND STREET 7TH FLOOR NEW YORK NY 10019 UNITED STATES
ITEM 2.
(A) NAME OF PERSON FILING
STATE STREET CORPORATION
SSGA FUNDS MANAGEMENT, INC.
(B) ADDRESS OF PRINCIPAL BUSINESS OFFICE OR, IF NONE,
RESIDENCE
STATE STREET FINANCIAL CENTER
1 LINCOLN STREET
BOSTON, MA 02111
(FOR ALL REPORTING PERSONS)
(C) CITIZENSHIP: SEE ITEM 4 (CITIZENSHIP OR PLACE OF
ORGANIZATION) OF COVER PAGES
(D) TITLE OF CLASS OF SECURITIES
COMMON STOCK
(E) CUSIP NUMBER:
032797300
ITEM 3.
IF THIS STATEMENT IS FILED PURSUANT TO RULE 13D-1(B), OR 13D-2(B)
OR (C), CHECK WHETHER THE PERSON FILING IS A:
SEE ITEM 12(TYPE OF REPORTING PERSON) OF THE COVER PAGE
FOR EACH REPORTING PERSON AND THE TABLE BELOW, WHICH EXPLAINS
THE MEANING OF THE TWO LETTER SYMBOLS APPEARING IN ITEM 12 OF
THE COVER PAGES.
SYMBOL CATEGORY
BK BANK AS DEFINED IN SECTION 3(A) (6) OF THE ACT.
IC INSURANCE COMPANY AS DEFINED IN SECTION 3 (A) (19)
OF THE ACT
IC INVESTMENT COMPANY REGISTERED UNDER SECTION 8 OF
THE INVESTMENT COMPANY ACT OF 1940.
IA AN INVESTMENT ADVISOR IN ACCORDANCE WITH RULE
13D-1(B) (1) (II) (E).
EP AN EMPLOYEE BENEFIT PLAN OR ENDOWMENT FUND IN
ACCORDANCE WITH RULE 13D-1(B) (1) (II) (F) .
HC A PARENT HOLDING COMPANY OR CONTROL PERSON IN
ACCORDANCE WITH RULE 13D-1(B)(1)(II) (G).
SA A SAVINGS ASSOCIATIONS AS DEFINED IN SECTION 3(B)
OF THE FEDERAL DEPOSIT INSURANCE ACT (12 U.S.C. 1813).
CP A CHURCH PLAN THAT IS EXCLUDED FROM THE DEFINITION OF
AN INVESTMENT COMPANY UNDER SECTION 3(C)(14) OF THE
INVESTMENT COMPANY ACT OF 1940.
CUSIP NO: 032797300 13G PAGE 5 OF 7 PAGES
ITEM 4. OWNERSHIP
THE INFORMATION SET FORTH IN ROWS 5 THROUGH 11 OF THE COVER PAGE
HERETO FOR EACH OF THE REPORTING PERSONS IS INCORPORATED
HEREIN BY REFERENCE.
ITEM 5. OWNERSHIP OF FIVE PERCENT OR LESS OF CLASS
NOT APPLICABLE
ITEM 6. OWNERSHIP OF MORE THAN FIVE PERCENT ON BEHALF OF ANOTHER PERSON
NOT APPLICABLE
ITEM 7. IDENTIFICATION AND CLASSIFICATION OF THE SUBSIDIARY WHICH
ACQUIRED THE SECURITY BEING REPORTED ON BY THE PARENT HOLDING
COMPANY OR CONTROL PERSON
SEE EXHIBIT 1 ATTACHED HERETO
ITEM 8. IDENTIFICATION AND CLASSIFICATION OF MEMBERS OF THE GROUP
NOT APPLICABLE
ITEM 9. NOTICE OF DISSOLUTION OF GROUP
NOT APPLICABLE
CUSIP NO: 032797300 13G PAGE 6 OF 7 PAGES
ITEM 10. CERTIFICATION
BY SIGNING BELOW I CERTIFY THAT, TO THE BEST OF MY KNOWLEDGE
AND BELIEF, THE SECURITIES REFERRED TO ABOVE WERE ACQUIRED AND ARE
HELD IN THE ORDINARY COURSE OF BUSINESS AND WERE NOT ACQUIRED AND ARE
NOT HELD FOR THE PURPOSE OR WITH THE EFFECT OF CHANGING OR INFLUENCING
THE CONTROL OF THE ISSUER OF THE SECURITIES AND WERE NOT ACQUIRED AND
ARE NOT HELD IN CONNECTION WITH OR AS A PARTICIPANT IN ANY TRANSACTION
HAVING THAT PURPOSE OR EFFECT.
SIGNATURES
AFTER REASONABLE INQUIRY AND TO THE BEST OF HIS KNOWLEDGE AND
BELIEF, EACH OF THE UNDERSIGNED CERTIFIES THAT THE INFORMATION SET FORTH
IN THIS STATEMENT IS TRUE, COMPLETE AND CORRECT.
STATE STREET CORPORATION
ELIZABETH SCHAEFER
SENIOR VICE PRESIDENT, DEPUTY CONTROLLER
SSGA FUNDS MANAGEMENT, INC.
JACLYN COLLIER
CHIEF COMPLIANCE OFFICER
EXHIBIT 1
THE FOLLOWING TABLE LISTS THE IDENTITY AND ITEM 3 CLASSIFICATION
OF EACH SUBSIDIARY OF STATE STREET CORPORATION, THE PARENT HOLDING
COMPANY, THAT BENEFICIALLY OWNS THE ISSUER`S SECURITIES. PLEASE
REFER TO ITEM 3 OF THE ATTACHED SCHEDULE 13G FOR A DESCRIPTION OF
EACH OF THE TWO-LETTER SYMBOLS REPRESENTING THE ITEM 3 CLASSIFICATION
BELOW.
SUBSIDIARY ITEM 3 CLASSIFICATION
SSGA FUNDS MANAGEMENT, INC. IA
STATE STREET GLOBAL ADVISORS EUROPE LIMITED IA
STATE STREET GLOBAL ADVISORS LIMITED IA
STATE STREET GLOBAL ADVISORS TRUST COMPANY IA
NOTE: ALL OF THE LEGAL ENTITIES ABOVE ARE DIRECT OR INDIRECT SUBSIDIARIES
OF STATE STREET CORPORATION.
CUSIP NO: 032797300 13G PAGE 7 OF 7 PAGES
JOINT FILING AGREEMENT
IN ACCORDANCE WITH RULE 13D-1(K)(1) UNDER THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED (THE EXCHANGE ACT), EACH UNDERSIGNED ENTITY (EACH A
COMPANY) HEREBY AGREES TO ANY AND ALL JOINT FILINGS REQUIRED TO BE MADE
ON THE COMPANY`S BEHALF ON SCHEDULE 13G (INCLUDING AMENDMENTS THERETO)
UNDER THE EXCHANGE ACT, WITH RESPECT TO SECURITIES WHICH MAY BE DEEMED
TO BE BENEFICIALLY OWNED BY THE COMPANY UNDER THE EXCHANGE ACT, AND
THAT THIS AGREEMENT BE INCLUDED AS AN EXHIBIT TO ANY SUCH JOINT FILING.
THIS AGREEMENT MAY BE EXECUTED IN ANY NUMBER OF COUNTERPARTS ALL OF
WHICH TAKEN TOGETHER SHALL CONSTITUTE ONE AND THE SAME INSTRUMENT.
IN WITNESS WHEREOF, EACH COMPANY HEREBY EXECUTES THIS AGREEMENT
EFFECTIVE AS OF THE DATE SET FORTH BELOW.
STATE STREET CORPORATION
ELIZABETH SCHAEFER
SENIOR VICE PRESIDENT, DEPUTY CONTROLLER
SSGA FUNDS MANAGEMENT, INC.
JACLYN COLLIER
CHIEF COMPLIANCE OFFICER
You must be suggesting FDA "hanky panky", since they were the one requesting AUC for the small AVATAR trial...
In any event AS WITH THE AVATAR and US Rett trials, EXCELLENCE endpoints are all "Change from baseline to End of Treatment (EOT)". No AUC hanky panky!
Nor did the AVATAR endpoint ever officially, as in on clinicaltrials.gov.
Well, as far as we can tell, the EXCELLENCE trial's endpoints have never officially changed from the beginning of the trial through to its recent conclusion.
Looks like there is another beneficial owner over 5%.
No he did not!
Missling indicated that in the EXCELLENCE trial, unlike the AVATAR trial, there will be no statistical need for anchoring given the greater number enrolled in EXCELLENCE.
NOPE... only FUDspects might wonder why.
Let's dive in and separate CGI-Anchoring and EOT vs. AUC, two very different concepts.
Dr.M still stumbled over explaining RSBQ, RSBQ-AUC, CGI, and CGI anchored scores.
E. Planning for Clinical Trial Interpretation Using a Responder Definition
Regardless of whether the primary endpoint for the clinical trial is based on individual responses to treatment or the group response, it is usually useful to display individual responses, often using an a priori responder definition (i.e., the individual patient PRO score change over a predetermined time period that should be interpreted as a treatment benefit). The responder definition is determined empirically and may vary by target population or other clinical trial design characteristics. Therefore, we will evaluate an instrument’s responder definition in the context of each specific clinical trial.
The empiric evidence for any responder definition is derived using anchor-based methods. Anchor-based methods explore the associations between the targeted concept of the PRO instrument and the concept measured by the anchors. To be useful, the anchors chosen should be easier to interpret than the PRO measure itself. For example, the number of incontinence episodes collected in incontinence diaries has been used to determine a responder definition for PRO instruments assessing the annoyance of incontinence. A 50 percent reduction in incontinence episodes might be proposed as the anchor for defining a responder on the PRO instrument. Confirmation of this anchor approach in early clinical trials can provide the basis for the proposed responder definition in the confirmatory trials.
Another anchor-based approach to defining responders makes use of patient ratings of change administered at different periods of time or upon exit from a clinical trial. These numerical ratings range from worse to the same and better. The difference in the PRO score for persons who rate their condition the same and better or worse can be used to define responders to treatment. Patient ratings of change are less useful as anchors when patients are not blinded to treatment assignment.
Another set of approaches to defining a responder are distribution-based methods that use, for example, the between-person standard deviation or the standard error of measurement to define a meaningful change on a scale. Distribution-based methods can be used to categorize these changes as small, moderate, and large and often can be combined with anchor-based estimates to provide confidence in the responder definition. Distribution-based methods for determining clinical significance of particular score changes should be considered as supportive and are not appropriate as the sole basis for determining a responder definition.
Alternatively, it is possible to present the entire distribution of responses for treatment and control group, avoiding the need to pick a responder criterion. Whether the individual responses are meaningful represents a judgment, but that problem is present with almost all endpoints except survival. Such cumulative distribution displays show a continuous plot of the percent change from baseline on the X-axis and the percent of patients experiencing that change on the Y-axis. This display type may be preferable to attempting to provide categorical definitions of responders. A variety of responder definitions can be identified along the cumulative distribution of response curve.
Guidance on interpretation considerations for a clinical trial’s SAP is found in section V.E., Interpretation of Clinical Trial Results.
25
Yun Zhong
Okay. And then switching to the Rett syndrome study. I believe though press release announcing over enrollment had the language that with the FDA's input, you are using the primary endpoint. So I wanted to confirm that the primary endpoint is RSBQ and you see similar to -- or the same to the one used in the EBITDAR study? And so has the FDA agreed that the AUC, the modified RSBQ scale can be an appropriate endpoint for Rett syndrome study?
Christopher Missling
Yeah. We have it described in clinicaltrial.gov, and it was also never change in clinicaltrial.gov for the EXCELLENCE study. It is the RSBQ primary endpoint, and the CGI is key secondary endpoint over the course of the trial.
Yun Zhong
Is that the same endpoint that was used in the AVATAR study?
Christopher Missling
Slightly different. So it's actually the measurement over time from beginning to end of trial. AUC.
Yun Zhong
Not AUC?
Christopher Missling
Not AUC.
Yun Zhong
Not AUC?
Christopher Missling
Exactly, yes. Because the study is large enough that it can carry the signal by itself without AUC.
Anyone wonder why AVXL is still registered and incorporated in Nevada?
Anyone know of a real = non-grift firm that isn't incorporated in Delaware?
That's where corporations have the most protection
Yes, but that includes all unexercised options.
Christopher U. Missling MS PhD MBA is the beneficial owner of 6,229,644 shares of AVXL stock.
See page 73
https://www.sec.gov/Archives/edgar/data/1314052/000173112221002062/e3306_10-k.htm
Good luck and GOD bless,
CM is already a shareholder... roughly 1M shares.
EXPECT regulatory approval for Anavex's blarcamesine BEFORE the end of 2023.
Good luck and GOD bless,
All drugs and reagents were obtained from Sigma-Aldrich except PRE084 (Cayman), and SKF10047 and BD1047 (Tocris Bioscience).
NOT if rather WHEN Anavex's blarcamesine is approved by the FDA, then the AVXL stock price will be much much much higher than it is today.
GOD bless,
"Already making money."
Based upon the time of your post below, you went short somewhere between $11.09 - $10.65. Of course, you don't bother to state your actual price and position size...
Did you dump all of your long shares (assuming you even had any) yesterday?
As usual AVXL goes straight down and circling the drain.
Already making money.
Yes, Bas....that is the question!
Does he exercise and hold some or all of the stock or does he exercise and sell all of these very low strike calls before or after they are due to expire! These are so cheap (exercise price) that he can easily pay for them...but I would assume he wants to use a cashless exercise for some of them....we'll see the Form 4 and 8k on that, 2 days after that occurs.....insider reporting rules...
He will be an owner of shares and can be like us or he can jump out with a good profit assuming the price is good. He is totally vested now, so that can happen at any time up to July 5th.
How long have you been claiming short squeeze? How much is institutional ownership? Oh yeah...
All the lies about meeting primary endpoints.
RSBQ-AUC
ODDS RATIOs
Arbitrary thresholds
logistic regression
No one buys the nonsense. Now needs dilution to continue. No partners or approvals in the next decade.
It's time to invent another endpoint for pediatric Rett trial to claim success.
this could be the lower high
and shorts could win big time since there is no interest in buying this other than retail
As usual AVXL goes straight down and circling the drain.
Already making money.
I stand corrected...the market does not like the dilution news or Anavex...lol
Yes that is great because the 100% dilution over the last few years doesn't make up for low dilution last year...lol
Ah, FDA approved RSBQ-AUC for primary endpoint, how wonderful!
New article TODAY
This Short-Squeeze Candidate Could Actually Pan Out in the Long Run
Legit short squeezes are fairly rare. But when they do occur, shareholders of heavily shorted equities can generate enormous returns on capital in an exceedingly short period.
Which under-the-radar equity stands out as a top short-squeeze candidate right now? The developmental biotech Anavex Life Sciences (AVXL -6.98%) ticks off some of the most important boxes in this regard.
To be fair he said, FUDsters, which would only apply to YOU, if the shoe fits.
Yet FUDsters like to deny that's true.
It's comments like this that reveal the real FUDspects...
Or he’s just leading people on in order to collect his big salary. We ll know in another 4 years
Yup a shorts dream is for us long investors to sell our shares to them.
I have something to say about that:
PAY UP!!!
that these people don’t sell their stock and invest elsewhere. There are plenty of good investment opportunities, such as municipal bonds, which are very attractive right now, or large-cap stocks that pay good dividends.
You can buy these and sleep well at night without having to worry about a cabal.
I haven’t denied that. So that’s another False comment on your part. So you are spreading more FUD!!!
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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