Anavex Life Sciences Corp (AVXL)

[nidan7500]

$388...more like it.

[FooBarAndGrill]

In that Schitzo unit, I'm guessing Nurse Betty comes in with the pill and you take it ... because Nurse Betty says so.

[ExtremelyBullishZig]

HC Wainwright reiterate by at $40. Why not $400 or $4000...no basis...

[k9uwa]

"I gather that AdamF" Yes back in mid March when the FIRST law firm KORSINSKY lawsuit was filed. Korsinsky article said Our BioTech Journalist Adam F said. Also if you go back look at AVXL back in 2017 Same Law Firm Same AF. Then it took us several years to recover from that attack.

John k9uwa

[baltimorebullet]

$3.88

[boi568]

The AD trial succeeded against the FDA draft guidance criteria through its ADAS-Cog result. (It succeeded under the .025 methodology, as well.) So long as the Agency's draft guidance is finalized before a decision is rendered on any Anavex AD NDA, or so long as the draft guidance is informally governing FDA practice now and remains unchanged, Anavex's 2b/3 AD trial succeeded by the only way clinical trials are scored.

Success or failure is graded according to FDA standards, not prior practice or discarded or otherwise inapplicable rules. And certainly not by the opinions of message board posters.

[skitahoe]

I've got to admit that during part of my treatment for leukemia, before stem cells, I was on a drug where two doses were expected to be taken 12 hours apart. Most of the time I was close, but occasionally it may have been as many as 16 hours, and then the next dose 8 hours later to get back on track. I would suspect that if it's really critical to have accurate dosing, and the patients have mental issues, some sort of unit, similar to an insulin pump will be developed and a patient's unit need only be refilled after a number of days, or even weeks.

If not that, perhaps a time release version that could be taken perhaps 12 hours apart. It may not be perfect, but it works better than every 6 hours.

Gary

[Anshu2]

Regarding small vs large trials: Most AD trials (except AVXL's) have indeed been very large -- but that is likely because the expected change in endpoints has been small. AVXL was expecting a larger change -- so, went with a smaller trial to save costs. Ultimately, p-value is what really matters (if safety is not an issue).

In either case, with respect to FDA/US, there may be a tiny change of AA (based on biomarker data) -- but otherwise AVXL needs another trial anyway for FDA approval (this new trial will likely be a large trial -- since the smaller one "failed").

[georgejjl]

The are capable of taking blarcamesine oral doses every 8 hours after taking blarcamesine for a few days to a week especially with the help of an electronic automated pill dispenser.

Below is just an example of one of may types of automated pill dispensers.

https://www.alzstore.com/electronic-pill-dispenser-p/0032.htm?gclid=Cj0KCQjw6PGxBhCVARIsAIumnWYfc6QyDodhchzlb2dLdmfzmVMBKMxZmvbJXta-H1XqbULLJuvvmcEaAjNEEALw_wcB&utm_source=google&gad_source=1&utm_campaign=High+Priority+-+PLA&utm_medium=pla

Dosing every 8 hours keeps the blood concentration as constant as possible for an oral medicine like blarcamesine.

Good luck and GOD bless,

[bb8675309]

I agree. I would much rather have every 6 hr. dosing. No side effects. Sleep great.

[rx7171]

I’m disappointed about the every 8 hour dosing.
Not really bad like infusions with serious side effects but requires the kind of discipline Schitzo patients may not be realistically able to self dose.

[ignatiusrielly35]

If so, his sponsor is wasting its money. Highly ineffective, and likely does not really even speak English, instead using a translation app. His conjugation and syntax are appalling.

[skitahoe]

I gather that AdamF has taken a shot here too. I hate to think of all the companies he's worked to bring down. Why he's respected by anyone I can't figure, but clearly he is.

Gary

[k9uwa]

Are they paying your extra for overtime pay?

John k9uwa

[kund]

Lol...delusional

[Steady_T]

As far as I can find Toutain had no options granted. He was not mentioned in the 10K. It doesn't appear that he was considered a high level employee.

His new gig offers options and a salary that is most likely a real step up. Seems like a straight forward move to me.

There is no evidence that he would gain a lot of benefit from sticking around even if AD is approved.

[bas2020]

Reference this little gem provided by Team Alpha Trading... calling for a GME/AMC style bull raid on NWBO to "kick the HF short manipulators in the nuts!"
Let’s hope it happens soon! Same manipulation crap is going on here with AVXL.

[k9uwa]

I watched the close and shortly after as well. Stark difference to previous several days where it was a sell off.
Of course everything KUND says is FUD. Most likely he is paid to be here like several others trying to convince retail to SELL and be gone. His comment we should be SUB $1 ... Looks like some of the smart shorts bought their way OUT today and probably a few others each of the last several days. Loved the questions today from the Analysts. And the Answers. Also interesting looked at latest buys sells AFTER HOURS. Someone bought I don't know how many shares at $3.92. Currently shows Bid and ask prices and quantity available.
Bid price by size
3.88 x by 100 shares
Ask price by size
3.92 x by 1900
Those have to be Good Till Filled orders.
Maybe another short buying his/her way out thinking that tomorrow might be too late. Monday coming up is "D Day" for the blood sucking lawyers to get their Lead Plaintiff ... or give it up. Most likely all of them have been short since the first day or two of the filing of the lawsuit. No Lead Plaintiff they will buy out of their short position. Could be some have already been working on buying out take what they have and be gone.

Tomorrow should be an interesting day.
John k9uwa

[georgejjl]

Expect a lot of exciting updates late this spring and this summer 2024:
From today's transcript:
"...In Rett syndrome, continued positive real-world evidence feedback from Rett syndrome patients and caregivers participating in the ongoing open-label extension trial and Compassionate Use Program for patients who participated in the EXCELLENCE trial encourages us to continue our partnership with the Rett syndrome community and to proceed with a Phase 3 12-week efficacy study. An educational presentation will be provided at the 2024 IRSF Rett Syndrome Scientific Meeting, taking place this year June 18, 2024 to June 19, 2024.
Regarding Parkinson’s disease, initiation of an ANAVEX2-73 Phase 2b/3 six-month trial is expected in the second half of 2024. In Fragile X, new specific translatable and objective biomarker data generated with ANAVEX2-73 supporting the initiation of the potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial will be presented at the 19th National Fragile X Foundation Conference taking place in July 25, 2024 to July 28, 2024. Related to a new rare disease, we are also in preparation to initiate a potentially pivotal ANAVEX2-73 Phase 2/3 trial.
With respect to ANAVEX3-71, we are quite pleased to provide an update that the placebo-controlled Phase 2 clinical trial of ANAVEX3-71 for the treatment of schizophrenia. The study is well underway with the first cohort of schizophrenia patients being fully enrolled. We are also expecting further peer-reviewed clinical publications in both -- involving both ANAVEX2-73 and ANAVEX3-71...."

Good luck and GOD bless,

[sage4]

Got ya. That’s new to me. Thanks

[123tom]

Thanks for seeing that.I wasn't watching the close. So would you think if price didn't move much, what could that suggest. I saw price bouncing up from 3.80 after holding support around 3.75.

[georgejjl]

Anavex Life Sciences Corp. (AVXL) Q2 2024 Earnings Call Transcript

https://seekingalpha.com/article/4691268-anavex-life-sciences-corp-avxl-q2-2024-earnings-call-transcript?utm_campaign=twitter_automated&utm_content=article&utm_medium=social&utm_source=twitter_automated

Good luck and GOD bless,

[mrplmer]

Would Toutain leave for a better package knowing what coming down the pike? There’s definitely more to his departure. High level people don’t leave at a time like this if they don’t have to.

Could you be number two to the least qualified CEO in NYC? Maybe he has a shot at the big job in a year or to there. I couldn't work for numbnuts as #2 that's for sure. Not sure how many here worked in the rarefied air but they did take Misslings CBOD job away for a reason. He is not a Senior Guy.

[mrplmer]

$2.70

[skitahoe]

It was quite positive, but about the small trials done at UCLA that used Poly-ICLC with DCVax-L, many patients living for ten or nearly ten years and still alive. The article wasn't being promoted by NWBO, or anyone else for that matter, as NWBO didn't sponsor the trial. IMHO NWBO's being heavily manipulate and will continue to be until the UK approval, then the news should overcome those working to control the share price. Their trial against the MM's for spoofing should be moving forward after multiple MTD's followed by more proof of the MM's actions.

Avanex should have no problem in PR'ing a Journal as they sponsored the trials being discussed in the Journal. Don't get me wrong, I'm sure if you attend ASCO they'll have copies of the article at their booth, but I know of no other formal presentation of the data discussed in the Journal there.

Gary

[Jonjones325]

Varying degrees of being pulled in after being shown most of the data. Most means the most important parts without hiding anything.

-The data looks good. We think you should take a chance and file. And if the rest is good, you may have a shot.

-You should definitely file. Although not a slam dunk, we’ve never seen data like this especially in brain atrophy. We think you have a really good chance.

-This data is quite impressive. We are desperate for something safe and effective. The upstream MOA and peripheral benefits is what we need. Let’s get it going. We’ll support you along the way. What are you waiting for?

I’m guessing somewhere between 2 and 3. Being pulled is pretty strong language. Stronger than suggested. Pulling almost indicates a little convincing.

Maybe I’m reading too much into the word. Missling also seemed optimistic about the MAA profess. Almost as if they were ahead for once.

Insider purchases don’t bother me much as a 5-10k share purchase would be a token symbol. Living in NY is not cheap. Why toss 30k dollars down when you have options and time?

Peer review still annoying as hell. I’m not reading into the delayed ASM as anything unusual. He is definitely annoyed about how long it’s taking.

The company did a good job hiding the COO departure as the analysts would have surely asked about it if they knew. Would Toutain leave for a better package knowing what coming down the pike? There’s definitely more to his departure. High level people don’t leave at a time like this if they don’t have to. Forced to.

There’s writing on the wall. He saw it and left on his own terms. Career flop averted.

[powerwalker]

george, 2014 is an agnostic if I remember correctly. He doesn't take off for Christmas, so why would he for the Ascension? 😉

[Steady_T]

Short position down 718,862 shares. About 3%.

[tredenwater2]

Its a long road Chemdeps and Dr. Missling has provided excellent leadership skills in organizing, funding, and ultimately bringing us the the precipice of approval with an astounding teams of professionals around him. His expertise shined quite brightly when discussing moving forward after approval for Alzheimer’s ALWAYS thinking first and foremost about shareholders and maximizing value He also shirked the MC as he has no control over the “fair and balanced” market indicating the whole thing is crazy, not just Anavex’s situation.

Many company’s in negotiations imo are probably scratching their heads at where we are and the leverage we hold with our data and large cash position. I may just double down at this crazy low price gifted to us.

Cheers

[kund]

New buzzword from TGD: "Stay Tuned" . Is he running radio station?

[nidan7500]

Anyone here venture to predict (guess) the SP of this at YE ?????? Come'on-put your Bigboy pants on

plexrec...YE prediction SP >$200/shr.

[Chemdeps]

I just finished listening to the CC and I agree. I was surprised by the additional detail that was provided indicating that after seeing the Alzheimers data the EMA requested that Anavex submit an application "immediately" and that Anavex was pulled into it (the submittal) as opposed to pushing the application with EMA. I also liked hearing that the cash runway of 4 years does not include the costs associated with marketing/commercialization of A-273 should the EMA offer approval. Rett feedback continues to be strong from the open label extension as well as support for P3 trial and Schizophrenia trial is moving very fast. The next six months should be interesting....

[Anshu2]

Delay in talking with the FDA regarding AD seems to be: Time taken to "analyze" the biomarker data, as I understand from the call (and perhaps, waiting for OLE data). Which means two disappointing things:

1. Primary/secondary end-point data is indeed not pivotal/FDA-approval worthy, even in CM's eyes. Fair enough.
2. Analyzing biomarker data -- takes them 2 years (!) post-completion. That is certainly not reasonable, by any stretch of imagination.

Too bad.

[mike_dotcom]

Short interest down slightly - 04/30/2024 21,289,889

[longtermbeliever]

over $4 tomorrow any thought.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

[tredenwater2]

Absolutely remarkable CC. Dr. Missling gives the minimum info as to not step outside legal bindings but when asked by analysts many items were offered. Dont these numbnuts know this….ask more questions!!

We are in a 1 year countdown for at least one but quite possibly multiple approvals.

Hang on, the peer review is the dam!!

[kund]

Sub $1....even that might be high for this POS....

[LakeshoreLeo1953]

I think you missed the point of the retort.
"100M" value with $139M cash stated.
Easy enough to deflect Kund's comment.
NOT a comment on burn rate, which should be lower
given current trial(s) status. BTW, given the math you did,
Anavex spent MORE than anticipated (albeit about the same as FX loss)
....with no further raise of capital.

I can see how George's knee jerk emoji confused you.

[k9uwa]

"predict (guess) the SP of this at YE" I say a considerable amount above this 3.88 close today. George will probably saw $100.00 pps. I think we are getting close to the goal line.

John k9uwa

[k9uwa]

"hold water with the auditors" perhaps a better explanation is. Anavex stated $150M at Year End. Good enough for a 4 year run. 150 / 16 = 9.375M per quarter. This statement is end of first quarter Mar30th 2024. 150 - 9.375 = 140.625M left in the band and we actually have 139M so quarter #1 they didn't spend quite as much as expected.

John k9uwa

[georgejjl]

Today is a holiday in Denmark, Feast of the Ascension

That is probably why he has not posted today.

It is a very good day for AVXL stock.

Good luck and GOD bless,

[LakeshoreLeo1953]

I doubt that interpretation would ever hold water with the auditors.

Hyperbole is not the friend of fringe assessment.

[boi568]

I am in favor of facts. They don't get along well with lies, a charming trait.

[kevindenver]

Odd, why can't I see "Investor2014"'s posts? I never had him on ignore?!?

Oh never mind he was just quiet today.

[kspar1]

Just scoot to the analyst questions. All the meaningful info came from that... for a change. Loved it. Insider buying, EMA, schizophrenia roadmap and all.

[Steady_T]

Thanks for that information. My next question is, can the same subjects be used in the part B of the study?

[Steady_T]

Rule 10b5-1 is sufficient to "close the window".

§ 240.10b5-1 Trading “on the basis of” material nonpublic information in insider trading cases.

(a) Manipulative or deceptive devices. The “manipulative or deceptive device[s] or contrivance[s]” prohibited by Section 10(b) of the Act (15 U.S.C. 78j) and § 240.10b-5 (Rule 10b-5) thereunder include, among other things, the purchase or sale of a security of any issuer, on the basis of material nonpublic information about that security or issuer, in breach of a duty of trust or confidence that is owed directly, indirectly, or derivatively, to the issuer of that security or the shareholders of that issuer, or to any other person who is the source of the material nonpublic information.

(b) Awareness of material nonpublic information. Subject to the affirmative defenses in paragraph (c) of this section, a purchase or sale of a security of an issuer is on the basis of material nonpublic information for purposes of Section 10(b) and Rule 10b-5 if the person making the purchase or sale was aware of the material nonpublic information when the person made the purchase or sale. The law of insider trading is otherwise defined by judicial opinions construing Rule 10b-5, and Rule 10b5-1 does not modify the scope of insider trading law in any other respect.

[plexrec]

Anyone here venture to predict (guess) the SP of this at YE ?????? Come'on-put your Bigboy pants on !!!!

[ignatiusrielly35]

I don’t think you meant to ask me this? I have the same question. I’ll guess that they have to be different patients due to exclusion protocol.

[ignatiusrielly35]

That is the only basis for an insider trading restriction that can think of in this situation. Having material inside information of whatever nature.