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UCLA sponsored the trial and I believe they were supported by the SPORE program, but I really don't know much about it. I believe that both Poly-ICLC and Keytruda were supplied. The DCVax-L was made at UCLA with the approval of NWBO and they called it by a different name but have clearly stated it's DCVax-L.
Gary
Not all trials are sponsored by the company who is developing the drug used in the trial?
Then who sponsors and why if don't mind to answer? Thanks.
Wish NWBO for justice!
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.
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,
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.
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
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.
george, 2014 is an agnostic if I remember correctly. He doesn't take off for Christmas, so why would he for the Ascension? 😉
Short position down 718,862 shares. About 3%.
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
New buzzword from TGD: "Stay Tuned" . Is he running radio station?
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....
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.
Short interest down slightly - 04/30/2024 21,289,889
over $4 tomorrow any thought.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
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!!
Sub $1....even that might be high for this POS....
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.
"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
"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
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,
I doubt that interpretation would ever hold water with the auditors.
Hyperbole is not the friend of fringe assessment.
I am in favor of facts. They don't get along well with lies, a charming trait.
Odd, why can't I see "Investor2014"'s posts? I never had him on ignore?!?
Oh never mind he was just quiet today.
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.
Thanks for that information. My next question is, can the same subjects be used in the part B of the study?
Rule 10b5-1 is sufficient to "close the window".
Anyone here venture to predict (guess) the SP of this at YE ?????? Come'on-put your Bigboy pants on !!!!
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.
That is the only basis for an insider trading restriction that can think of in this situation. Having material inside information of whatever nature.
Ty SBSS. Great presentation imo. Great expectations of approval still hanging with in the next year.
Most MAD studies do a 3 + 3 design. Enroll three at lowest (first) Dose then move to next dose if 0 patients have toxicity. If one has toxicity do three more patients and move to next dose if none of these have toxicity. Each dose is a cohort so each cohort has either 3 or 6
Most MAD studies do a 3 + 3 design. Enroll three at lowest (first) Dose then move to next dose if 0 patients have toxicity. If one has toxicity do three more patients and move to next dose if none of these have toxicity. Each dose is a cohort so each cohort has either 3 or 6
Are the same subjects being used in both part A and part B or are they two different sets of subjects?
Interesting watching the close today. Different from the last several days. Volume the last couple minutes showed some trades of around 10K shares all still at 3.88 3.88.5 with the total shares at 769,000 and in the last instant today additional 170,000 shares traded and price stayed the same 3.88 And then around 4:04PM an additional 61,000 shares traded. Price stayed the same at 3.88 with a total traded today of 1,000,000 shares. The big difference today... no large quick selling DOWN at end of day.
John k9uwa
Is that a good thing or a bad thing?
I am corrected. I didn't look it up for that post. I used the last 10K number.
I haven't read the PR or listened to the call yet.
Having the AC worked on and shoveled 1 cubic yard of soil before the rain this afternoon so I didn't take the time to check the most current number.
Don't count cash on hand, Misleading counts possible LPC dilution as cash, his cash and cash equivalence never goes down, it is same quarter after quarter.
Not sure even the harshest critics should place $30M as
the cost to liquidate..
I meant to say that the worth of this company is below $100 million, not its current valuation.
$175M may be an accurate valuation of IP.
Then again one would hope not.
I am guessing the office furniture is leased.
The estimated total enrollment is 40 men and women total
The 40 total is separated in to separate cohorts
Part A cohort 1 would be the 30 mg every 8 hours
Part A cohort 2 would be the 60 mg every 8 hours
and there would also include a placebo cohort for each
Part B cohort would be a TBD chosen from the above doses taken every 8 hours
and and there would also include a placebo cohort
The total of all these would add up to an estimate of 40 men and women total
Good luck and GOD bless,
Perhaps should have emphasized rhetorical question.
I certainly understand exchange rate effect(s), but WHY
if retaining cash from previous "dilution" would you hold
ANY overseas in this environment.
Seemingly Q to Q there is something abroad that devalued.
Now going forward may be a different matter....particularly given November.
So it took about six weeks to enroll Part A, which started around March 15. Assuming the same amount of time for Part B enrollment, this trial should easily complete by end of summer. Depending how long it takes in between Part A and Part B.
Price was jolted at the open, to hit the current targets of support(3.60 step) which held so far around 3.75 area, a higher high... so far, and resistance at 3.90 area, not hard to see on the chart. 3.80 is set as the balance line now, and today's small bounce , after holding support, has a chance to become a bullish rally follow up , to target 4.00 and climb higher steps 4.10/20/30/4.40 target zone, in a mathematical "finish" target. Simplest view is to call it a 1 dollar rally from the 3.25-3.40 "Bottom ". But the current battle isn't resolved yet, here at the key balance point 3.75/3.80... could still roll over, if they want it to.
In the larger chart view of the past month, the developing upwave looks to me like 3.25 Bottom , up 1 dollar, to target 4.25 top. And the downwave pattern would be the 3.90 resistance rollover area, down 1 dollar to target 2.90. In the middle is the key shoulder around 3.60
Was it a peer review article if it was in Nature?
I see sp reaction is kind of lukewarm. Was it positive article? Thanks.
Cohort divide (people) into groups with shared characteristics. And since there are only 2 Cohorts pretty good chance they are equal in quantity. Something I saw someplace that ALL of the patients in this test were Inpatients of the same facility? First part is 10 days and results will determine what quantity of 3-71 should be given to patients. 2nd 28 days all will get the same quantity.
John k9uwa
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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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