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Management will host a conference call on Monday December 5, 2022, at 8:30 am ET to review ANAVEX®2-73-AD-004 Alzheimer’s disease Phase 2b/3 study results.
https://www.anavex.com/post/anavex-life-sciences-to-announce-management-webcast-and-conference-call-on-monday-december-5-2022
MayoMobile
@JesseSatellite
·
33m
$AVXL just blew away amyloid-targeting results. ADAS-COG score in the entire dosed population (30+50mg cohorts) improved over 4 points which is statistically significant and clinically meaningful. CLINICALLY MEANINGFUL. #CTAD22
MayoMobile
@JesseSatellite
·
27m
Replying to
@CatbirdLit
Sure. Basically the CTAD attendees as a whole are pleased with Lecanemab data (which was good) but was not clinically meaningful. Blarcamesine was. It can make an extremely meaningful impact in a patients life. This is true disease modification.
Mayo posted on Stocktwits that he met Dr. Macfarlane.
Summary from presentation deck:
ANAVEX®2-73 treatment slowed decline of cognition and function in patients with early Alzheimer’s
disease over 48 weeks
• Patients on ANAVEX®2-73 treatment were 84% more likely to improve cognitively compared to placebo,
by ADAS-Cog score threshold change of -0.50 points or better
• ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks
• At clinically significant levels of improvement in function (ADCS-ADL score threshold change of +3.5
points or better), ANAVEX®2-73 treatment was 167% more likely to improve function compared to
placebo
• Compared to placebo, ANAVEX®2-73 reduced clinical decline of cognition and function by 27% as
measured by the CDR-SB
• ANAVEX®2-73 was safe and well tolerated
From Stocktwits:
Veliger
9m
$AVXL they didn’t even have a chance to look at high and low dose separately for all endpoints. Imagine how much better it will be when we see just high dose vs placebo across the board…and wild type patients. MacFarlane stated he only received the slides an hour before presenting. Company only received the data ~ 2 weeks ago. It will only look better when they can complete the full analysis. Very pleased. Presented well.
Bullish
I think we'll likely get the wide release pr at the usual 7am time tomorrow morning.
CTAD presentation isn't until 7:30pm ET. I would think an after hours pr or the usual 7am tomorrow.
Finally learned a lesson by not putting out the press release at 7am on a trading day so we don't get set up for a short attack.
Saw this on Facebook:
Anavex's address changed yesterday to 630 5th Avenue, NYC
(used to be 51 W 52nd Street, NYC)
The market is closed Monday, not Tuesday.
McMagyar, what company are you talking about?
December 15th is "around the end of the year".
"Exceptional year". I think we just experienced Dr. Missling's first pump.
I don't recall this many analysts asking questions on a call before.
509 patients across 52 sites in Alzheimer's study.
Brian Jones
@TraderBJones
·
2m
$SAVA
This is what a Buy algo looks like.
It's not just one pop and a drop.
All the buying is coming from one program.
$SAVA
— Trader Brian Jones (@MasterBJones) November 2, 2021
This is what a Buy algo looks like.
It's not just one pop and a drop.
All the buying is coming from one program. pic.twitter.com/agSls19IdJ
SAVAge beating.
Keep in mind that SAVA has 40 million O/S and AVXL has 70 million O/S. We have the better drug(s) though.
The only thing SAVA has over us is a lower float.
I'll take +35% every day.
Breaking News: A third member of the FDA's expert panel has resigned in the wake of the controversial Alzheimer's drug approval, calling it the "worst drug approval decision in recent U.S. history".
Breaking News: A third member of the FDA's expert panel has resigned in the wake of the controversial Alzheimer's drug approval, calling it the "worst drug approval decision in recent U.S. history" https://t.co/p2XCZqnHIN
— Max Gelman (@MaxGelman) June 10, 2021
"FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market."
UPDATE: FDA Says Is Requiring Biogen To conduct Post-Approval Clinical Trial To Verify The Drug's Clinical Benefit. $BIIB
Dr. Missling has said we will partner for Alzheimer's. Any revenue projections need to account for the partner's share.
That pr is a year old.
"AVXL run started with the $45 estimate
That lit the fire, been upward since."
$45 estimate? Been away from the board for a while. Where and when was that?
Walmart and Walgreens?:
https://twitter.com/K1eranQ/status/1343703427625398273
Noticing a trend. One by one, the competitors are dropping out in Alzheimer's and Rett.
New site added in Perth, Australia for Rett adult trial:
https://www.facebook.com/rettaustralia/posts/1259608807771844
Biogen dodges a bullet because a guy on the FDA panel has to recuse himself. He was part of the drug trial and thinks their drug is garbage.
AVXL presenting Parkinson's results at the biggest Alzheimer's conference in the world. Late breaking. Clinically meaningful. Statistically significant improvements.
I like to manage expectations. Under promise and over deliver, but it sure seems like we've got something here.
Good luck longs.
We have friends in high places. Paul Aisen on the CTAD organizing committee and both Aisen and Harald Hampel on the CTAD scientific committee.
Since Angelman Syndrome is another one of our targets, thought I'd post this nice Twitter exchange between a young girl and Mark Hamill:
Mark Hamill liked
Melissa Grace
@Melissassmile
Dear Mr @HamillHimself
You are so lovely in liking my posts about raising awareness of #AngelmanSyndrome
I’m sharing my achievements showing what is possible when you never give up but it’s tough
Would you please help me by joining as my Ambassador Red heart Thank you Love Melissa x
12:25 PM · Oct 18, 2020·Twitter for iPhone
Mark Hamill
@HamillHimself
·
7h
Replying to
@Melissassmile
Dear Melissa- By following you on Twitter & reading your tweets, I've been a supporter of yours all along. All the best, Mar camel
Dear Mr @HamillHimself You are so lovely in liking my posts about raising awareness of #AngelmanSyndrome😇
— Melissa Grace BCyA (@Melissassmile) October 18, 2020
I’m sharing my achievements showing what is possible when you never give up but it’s tough
Would you please help me by joining as my Ambassador ❤️ Thank you Love Melissa x pic.twitter.com/5d2QvriPfz
What exactly is Fadiran's purpose with the company if not to work the FDA "system"?
From a pr standpoint, Shake It Up will look foolish if PDD results are bad. I just can't see any way they would agree to fund the PD trial and announce it now unless they have some level of confidence that the imminent PDD results are good.
Shake It Up knows that PDD results are due any time now. Why would they make this commitment now unless they know the results are good? They could just wait until after results are made public and then decide. Seems obvious that they already know the answer. Say for argument's sake that the results are bad. Shake It Up would look like idiots to have made this commitment now. Makes no sense unless the results are good.
Pretty simple really. Would the mom agree to appear in the news story with her daughter if the drug wasn't working?
Conflicted. On the one hand, every time I've gotten excited about AVXL over the last five years, the shorts and fudsters kill the stock. On the other hand, the overlap of earnings and projected PDD results timeline, along with the out of character move of the CC from 4:30pm to 11am prime time signals that something big is afoot. Trying to stay level. Hoping for the best and preparing for the usual fudstorm.
The patent is only a concern if the drug works. That would be a good concern to have.