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Great post Bas, thats how Dr Missling explained the reason the odds ratio was used.
The MB expert’s just won’t accept it.
The final dosing for the EXCELLENCE trial is scheduled for today!
Now the clock starts for the readout.
July-August perhaps?
Joseph, you do realize that most employees working from Anavex are living in New York City probably not making a huge salary, mostly being paid in options?
These people aren’t rolling in cash to purchase tons of Anavex shares like apparently you imagine.
Hey JJ, maybe it’s something like this-
If you were to win a 500million Powerball lottery, would you immediately run down the street waving the lotto ticket yelling. “I won, I won”?
Of course not. You would take a few weeks or months get your ducks in a row, hiring lawyers, accountants, financial advisors, arranging your security needs etc.
Perhaps Dr Missling gave out just the minimum readout data, proclaiming that endpoints were met.
If A2-73 is indeed an industry disrupting drug which will have a big impact on the pharma and health care industry, Anavex needs to have an iron clad full data report to back it up.
I believe that they are in the process of scrubbing the data inside and out with KEM analysis and hiring FDA’s lead biostatistician , Dr Jin.
We will find out in the next few months if Anavex and us patient investors hit gold.
Dr Missling referred to the AD trial as a “phase 3” in the video!
I don’t believe that there is an issue with FDA communication. Just because he doesn’t PR evey move he makes, doesn’t mean it’s not happening. Unlike SAVA or BIVI pumping their SP.
We have three exFDA employees that I doubt are sitting on their hands even though we never hear about them.
Great post Hoskuld! Glad to see you post again. I always enjoyed your posts.
You forgot two more important “saviors “-
My personal favorites, ffrol and amateur!
I thought that Phase 1 trials were no longer needed for A2-73. The safety profile has already been established.
For all the posters here that are so worried about Anavex’s transparency, here is a clip from article about another Baby bio-
. “The company was sharing the kinds of responses they were seeing with the trial, and also the extreme pseudoprogression in the tumors. Adam got an interview with MDAnderson’s Dr. Aman Buzdar who claimed to have never in his lifetime ever have seen a company share their results of their trial before it had been peer reviewed and published. He told Adam how unprofessional this was (meanwhile, he’d done the same for a breast cancer drug he’d worked with). Of course, this was mana from heaven for Adam. And his article was cited in the lawsuits that followed after the share price tanked.
So, I think it’s partially for these reasons that the company is very careful with what they publicly communicate. The other reason is, of course, that the regulators don’t want to see them promoting their as-of-yet unapproved product.”
Thanks Abe, do you know who the other guy is?
Note the Anavex posters behind them!
Could be the reason Anavex has delayed starting any new trials, i.e Fragile X, new rare disease, or A3-71 schizophrenia.
Better to be more conservative and focus on AD and RETT, than burn through a bunch of cash having too many irons in the fire at the same time.
Anavex is getting all of their ducks in a row .
We will see soon.
A frugal company like Anavex doesn’t keep hiring for future expansion positions with bad data in hand and a bleak outlook.
Ignore the Fudsters
Thanks Plex, here is the link https://shakeitup.org.au/
Berenberg Bank Sticks to
Their Buy Rating for Anavex
Life Sciences (AVXL)
In a report released today, Caroline Palomeque from
Berenberg Bank maintained a Buy rating on Anavex
Life Sciences (AVXL - Research Report), with a price
target of $40.00. The company's shares opened today
at $8.45.
Lots of doom and gloom around here.
Why would someone spend hours per day posting on a small biotech company’s message board that they don’t believe in the drug and distrusts the management?
Is it entertaining? a hobby maybe?
No wait, it’s to save us unknowing investors from losing all of our money.
Anavex Life Sciences (AVXL)
Gets a Buy from
JonesTrading
Mar 30, 2023, 10:45 AM
In a report released today, Soumit Roy from
JonesTrading maintained a Buy rating on Anavex Life
Sciences (AVXL - Research Report), with a price target
of $58.00. The company's shares opened today at
$8.86.
According to TipRanks,
Que Adam F$&kstein tweet!
TTTavv66 on stock twitz—-
TTTav66 3/27/23, 11:13 PM
SAVXL Excellent podcast discussion
Rett Syndrome Tomorrow:
Management Options on the Horizon
ivoox.com/rett-syndrome-tom.
..experts in Rett syndrome David N.
Lieberman, MD, PhD, and Jeffrey
Neul, MD, PhD, discuss trofinetide
and blarcamesine, 2 agents in late-
stage clinical trials as treatment
options for Rett syndrome.
Throughout their conversation, Drs
Lieberman and Neul review the
pivotal LAVENDER, DAFFODIL,
AVATAR, and EXCELLENCE trials,
including information on the safety
and efficacy profiles of trofinetide
and blarcamesine..." Bullish
We should ask Dr. Jin! I’m sure that he would love to go to work for a scam company just for a little adventure!
MICROBIOME MOVEMENT
DRUG DEVELOPMENT
Conference Day 2
Thursday, June 30 2023
NAVIGATING THE REGULATORY JOURNEY:
APPROVAL TO COMMERCIALIZATION
5:00 pm Measuring Gut Microbiome
Responses in Alzheimer's & Parkinson's
Dementia
Christopher U Missling
President & Chief Executive Officer, Anavex Life
Sciences Corp.
Synopsis
Exploring gut microbiota as a source of potential
biomarkers in CNS
Analysing ANAVEX®2-73 alzheimer's and
parkinson's dementia clinical studies to
understand microbial interactions
FDA indicates willingness to
approve Biogen ALS drug de-
spite failed PhIII study
Ahead of Wednesday's advisory committee
hearing to discuss Biogen's ALS drug
tofersen, the FDA appeared open to
approving the drug, newly released briefing
documents show.
Citing the need for flexibility in a devastating
disease like ALS, regulators signaled a
willingness to consider greenlighting
tofersen based on its effect on a certain
protein associated with ALS despite a failed
pivotal trial. The documents come after
regulatory flexibility was part of the same
rationale the agency expressed when
approving an ALS drug last September from
Amylyx Pharmaceuticals,
I agree, we don’t know how long this relaxed approval mode is going to last with the FDA.
With convincing AD data in hand, they should file as soon as makes sense, even if it means forfeiting the Rett voucher.
There is little doubt that Anavex is suffering from a credibility problem. Perhaps hiring Dr Jin was part of the steps to correct this.
https://www.mja.com.au/journal/2023/218/6/assessing-preparedness-alzheimer-disease-modifying-therapies-australasian-health?utm_source=carousel&utm_medium=web&utm_campaign=homepage
Heather M. O'Leary
Anavex Life Sciences Corp
Vanessa Vogel-Farley
Anavex Life Sciences Corp
Katherine V. Barnes
Anavex Life Science Corp
?? New hires?
Maybe that’s the plan.
Hiring Dr Jin goes a long way to gain credibility for Anavex.
“Clinical data of blarcamesine in Alzheimer's disease, Parkinson's dementia,
and Rett syndrome - relevance to childhood dementia
Christopher U Missing, PhD, Anavex Life Sciences, USA”
From the Australian presentation yesterday!
Thanks Plex!
The peer review paper might take a while. They said once they have the full data, they will submit it for peer review.
Hopefully they will release the data before the paper is published.
This investment requires A LOT of patience!
AVXL confirms that it does not
hold any deposits or securities or
maintain any accounts at Silicon
Valley Bank.
From 8k today-
01?Regulation FD Disclosure.
Anavex Life Sciences Corp., a Nevada Corporation (the “Company”) confirms that it does not hold any deposits or securities or maintain any accounts at Silicon Valley Bank.
He was just making fun of George and some others perceived as pumpers
But what about the big announcement on the 28th?????
LOL
ANAVEX
LIFE SCIENCES Corp.
Biostatistics Internship Application
Full-time & Part-time Summer of 2023 Internships, 10-12 week program beginning in
May and June of 2023
All fields marked with * are required and must be filled.
Anavex Life Sciences Corp. is seeking talented and highly motivated future leaders in
statistics and biostatics to join our team during a Summer of 2023 Biostatistics Internship.
We are currently seeking candidates who are working towards obtaining a Ph.D. (preferred)
or master's degree in statistics or biostatistics for a 10-12 week internship (remote-
position) from May or June to August or September 2023 (dates are flexible). Anavex has
multiple full-time and part-time internship openings available. In addition, part-time
internships are available during the school year and may extend for a longer period of time.
As a biostatistics intern at Anavex, you will work closely with expert statisticians to work on
statistical programs from real-world clinical trials,
All candidates must have completed at least two years of coursework, have effective oral
and written communication skills, have good working knowledge of SAS and/or R, be
authorized to work in the US, and must not be employed at the time when the internship
begins.
To Apply: Complete the form below and click the green submit button.