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yes need to see two NDAs filed this year.
no reason to dither.
Share volume is terrible, should be 5 million, not 500K. Announce that PD trial commencing, Dr. M. release the full alz data. Get those NDAs filed. Have clint talk to Fidelity and other sector funds.
NOPE: if we don't present at AAIC this years is make me to believe DR.M is working on the partnership deal
NDA maybe. was quite clear partnership comes only after approval.
So the latest they could have submitted an abstract is April 23.
Would they have been ready by then?
FYI - Important AAIC 2023 Dates:
https://aaic.alz.org/abstracts/overview.asp
That's why journal articles are a waste of time. We're not going for tenure.
File an NDA and the stock will double, upon approval it will at least double again.
FDA is all that matters.
Not until AVXL hits $130 a share at least. There is a place for happy, happy people. Maybe this is it,
Until then it is a trier of patience.
CLEARLY WRONG: 4 out of the last 5 Superbowl winners are teams that have switched coaches a ton.
gee, dont you get this will be checked? LOL 2 of the last five winners are KC with Andy Reid, no turnover there. And a third was NE Pats will forever Bill Belichik.
Consider yourself DEBUNKED!
Such silly nonsense
the idea that you change the CEO and the change will be for the better.
Tell that to the NY Jets, 22 head coaches with an average tenure of less than 3 years. 1 Super bowl ring.
Pittsburgh Steelers 3 coaches 6 rings. NE Pats 6 + 2 rings with one guy over the last 22 years.
Nothing could be more damaging than to change the CEO now right as we approach the finish line. Which makes me wonder why one would suggest such silly nonsense.
I'm not a big cabalist, but one can anticipate the actions of market makers, who often post negative messages on stock boards to drive the price down. It is like waves in the ocean and you can game a wave. on the other hand, if you think a company's management is corrupt, there is nothing that can be done other than to sell the stock
Waagh, waagh. In spite of bashing, they still are buying.
Sales force is part of marketing. that can be contracted to McKesson.
anyone who claims to be invested in AVXL while saying the trial was a failure and the numbers are "cooked" is behaving irrationally. if one believes that, one should not be invested in AVXL.
the information in your post is inaccurate and unfounded. of course no source was supplied since it is made up
Due to his arrogance, I believe we will have to go the AD, PDD route alone. Remember what he originally did with MS and fell on his face.
LOL, Dr. M didn't take a sucker MS deal from crappy Biogen. Thank God!!
As for going it alone, he has manufacturing in place, so what does a partner offer other than marketing, which we dont need for Rett anyway, and can be contracted to McKesson for alz.
LOL, nice try.
I understand exactly how LPC operates.
It is clearly acknowledged that LPC are not investors. LOL
What I also understand is that using a vulture fund for your cash is expensive for shareholders
Except it is not a vulture fund, they are only placing shares in the market. So again, the statement is not true, LOL.
As to Missling being a one-man band, it’s quite obvious based on the 10-year history that he’s an autocratic CEO with little interest in sharing the spotlight or giving anyone credit for anything. Obviously, he does have people on staff, so he is not doing everything himself.
So he is delegating but yet he is a one man band? LOL, too funny. Take a position already!
As to the BOD, Missling has never been accountable to anyone. He has served as chairman of the board and has friends on the board.
Like what, 75% of the Fortune 500. Now he is even going the next step on good governance, giving up the Chairman of the Board position to a separate person.
Your post comprehensively debunked itself! LOL!
fake news headlines
LOL you think they're working 40 a week?!?! Maybe a month.
You know this exactly how? oh right, you just made it up.
He has access to virtually unlimited and unchecked cash through his arrangement with his vulture investor, Lincoln Park Capital. He can spend whatever he wants to make Anavex look like a big company because he has LPC and is unaccountable to shareholders.
Correct. Anytime the stock increases some, Missling will tap LPC and sell off more shares, giving him more cash and continuing to dilute current shareholders, which is not his problem.
Totally incorrect. Lincoln Park is not an investor in AVXL. they place shares in the market, and the amount they will place is NOT unlimited. And a pre revenue biotech has to get funds to advance its product trials, nothing unusual there, if you think there is, you should not be in biotech. What we do konw for sure is Dr. M has taken measures to minimize dilution such as seeking funding from foundations and the Australian govt. He has been A+++ at minimizing dilution.
1. When the company announced Avatar p2b/3 TLD in Feb/2021, it was a surprise that the endpoints changed to AUC. The company indicated the AUC provides better indication and insinuated the change was under regulatory guidance.
So we should meet the FDA's requirements, correct? Or do you prefer we give them the finger?
2. No Rett NDA was filed.
.
It has always been crystal clear that the NDA would be filed after the Excelllence trial was done. Fake news to say otherwise.
3. When the company announced AD p2b/3 TLD in Dec/2021, it was a surprise again that the endpoints changed to OR from the initial mean difference. Cantor had enough and dropped the coverage.
Cantor dropped coverage because they didnt get a stock offering to sell.
4. In May 2022, the company announced the intent to try AA biomarkers approach instead of the original/traditional approval approach.
Why would you not use the approach that worked for the last 2 alz drugs?
5. One can draw his/her own conclusion when the pattern continues...
One certainly can, same with commentary.
Not sure why you are disappointed with good decisions:
1. Decided to try AA using biomarker instead of regular approval. This will get us to market faster and makes it easy since our data will be much better than Biogens or Lilly's who used the same path.
2. Admitted in CC the use of AUC in Avatar is due to not enough power in the trial. Of course you left out that Excellence trial is just completed, so shouldbe full speed ahead on Rett.
3. I'll give you this one. Taking too long to get going.
As for hiring, anyone working in a skilled profession knows hiring good people these days is VERY hard. Zoomers are a small generation, and a lot of them are messed up in the head, so pool of normal skilled people is tight and highly competitive.
LOL, so take your word over facts.
First off, Lincoln Park isnt an investor in Anavex. That's your first error. They just place shares.
Second, Dr. M is accountable to a board which will soon have an independent Chairman. That;s corporate goverance better than 90% of American companies.
Third, it this was the one man bad show you claim (which is isn't), there would be no need for these hires at the seconday level, since they aren't in the corporate presentation anyway.
Consider yourself comprehensively debunked!
May 2023 Anavex presentation - listing of key employees
interesting AVXL hires not on the presentation list (except one)
Kun Jin - Vice President and Head of Biostatistics
Mireilly Figueroa - Executive Director, Clinical Data Management
Jordan Press - Associate Director, Clinical Operations
Adebayo "Bayo" Laniyonu - Pharmacologist | Senior Vice President, Nonclinical Development
Stephan Toutain - COO
Edison Guamba -Associate Director of Clinical Operations
Ashley Seragusa Senior Manager, Clinical Data Management
Tapas Saha, PhD Sr. Director, Medical Writing, Clinical Development
David Jerchower - VP of Clinical Supply
Clint Tomlinson - VP of Operations
Connor Peterson, M.D. - Medical Director
Katherine Barnes Madden - Senior Medical Science Liaison | Rare Disease | Translational Medicine | Clinical Operations
Steven P. Neilson- Vice President, Clinical Operations
David Goldberger - Senior Vice President Regulatory Affairs .
Alessandro Mammoli - Senior Project Manager
Michelle Robinson Moran - SVP Quality Assurance
AVXL is clearly not a one man band.
5 years. LOL LOL
You're funny.
there was no such screening limit for whom the drug was approved, at least so far. ... he commented on his observation that the mabs were only relevant to 20% of the AD market (of 6.5 million, as I remember). I think this issue will be brought up when Anavex goes to the FDA for approval.
yes this was interesting. basically saying the mABs are only getting a small piece of the market while 273 is essentially an option for the entire alz market. Which of course is another reason for Accelerated Approval
Any words of options wisdom? BTW raja is also a super options trader.
Doesn't this indicate PM trial is next probably? AM trial is in the morning. LOL
What is PM trial?
Any thoughts on whether they could see accelerated approval now? results were good and there are no good alternatives.
What if it is a lush partnership instead?
3 big blocks traded humm.JUST HOLD ON TIGHT
yep, after the 80K block midday yesterday. someone is accumulating
you totally made up those timelines.
Zero evidence this is true: Zero chance NDA is filed this year
Zero evidence for that statement. you can say it is unlikely,but that is very different from the precision of zero chance. If alz data comes out at AAIC in July, I would expect NDA files by September since they have a team of FDA hires to help and can work on many part of it already.
approval will happen 6 months from NDA,
maybe sooner given that I would expect there has been rolling data submissions and we're fast tracked
That said, MIssling just said data release this year.
Market seems not too impressed now that all the happy talk has subsided
Why would there be any market effect? there was no public PR.
After all the hard work by MM's this morning to lower price, I see that someone bought a block of 80,000 shares.
For all you do, MMs, this Bud Light is for you!
Nah, sooner: Rett perhaps approval in H2 2024. AD AA Perhaps after.
I would guess NDA filed this year and approval in H1 2024.
LOL, bootleg copies are not endorsed by the Company. But please check my notes to see if I got anything wrong.
your concern is touching. lots of coordinated concern this am from shorts and MMs
As lush as ever: Also how was Dr.M`s hair looking? No notes on the haircut? shame wink
Actually looked as if he could use a trim. Getting a touch of grey evenly scattered. Still has his Beethoven vibe.
It would be cool if he got a crewcut or mohawk when we get approval and go to war on alz.
If I wasn't optimistic I would not be deep in the stock for 8 years. That said, I am hoping for urgency in execution, which has been my biggest worry all along. Announcing the commencement of the PD trial this quarter and full data for AAIC on Jyly 17th would be very satisfying if they occur and would alleviate many concerns.
Pure FUD: Handful of people attended ASM but no one actually remember what Misleading said or how he said it,
We dont have alz, pal. We remember, and some were taking written notes to ensure it.
AD full data is still 2-3year away based on the attendees statements, approval is like 10year project.
Bald faces lies. No one is saying that who attended. now crawl back in your MM garbage can, Oscar.
$500K. That donut must have been good!