Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Hey Leo! I know you were recently looking to purchase on a break above $8.20 on strong volume (which we saw happen last week). Did you nibble...or were you fortunate enough to hold off and are now just watching?
FWIW - Most Read & Posted Boards on iHub over the past 24 hours:
Most Read Boards
Last 24 Hours
Rank Board Reads News Quote* Last Change Chg% Volume
1 NorthWest Biotherapeutics Inc 1,191,995 NWBO 0.7399 0.0534 7.78 2,173,763
2 Anavex Life Sciences Corp 530,483 AVXL 7.195 -0.375 -4.95 883,434
Most Posted Boards Today
Last 24 Hours
Rank Board Posts News Quote* Last Change Chg% Volume
1 NorthWest Biotherapeutics Inc 321 NWBO 0.7399 0.0534 7.78 2,173,763
2 Anavex Life Sciences Corp 227 AVXL 7.195 -0.375 -4.95 883,434
I called IR today and spoke with Clint....
Lot's of interesting info (all public) but with some clarification....He is very optimistic
and I gather (my own opinion) is that we are very close to several submissions and/or partners...Partner(s) do't have to necessarily come after AA submission. Anything can happen before...
I did get clarity on the ADL - significant end point and why it wasn't provided - I still believe it should have been provided although we chose the other path....
Does the risk of saving a lousy $17 really outweigh the reward of earning a potential $1,000+? C'mon man, go ahead and make that final deployment! Besides, LTB's buddies are probably itching to buy 200K shares at $7.01...hehe
Didn't you say late last week that you have a couple of friends that were each looking to buy 200K shares of AVXL? What are they waiting for? AVXL now available at a fire sale price. Tell them to jump on in!
we loongs should thanks the shorty so we can buy cheaper shares.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
FWIW - From MayoMobile's latest update:
Finally, it is our belief based on evidence procured earlier in the year that the company is under late-stage negotiations with a late-stage partner. We believe the following are the most likely in no particular order: Sanofi, Roche, Pfizer.
Hey hnbadger1 - It was just a thought I had and decided to throw out there...
Rett approval and AD AA sure as heck would be nice to see come to fruition. Of course, as always - time will tell.
“ I would think one has to assume that the latest stats presented were primarily the work of Kun Jin. Therefore, is it too outlandish to believe that (of all people currently walking around on Planet Earth) Kun Jin himself knows better than probably anyone else what the FDA will want to see in order for AVXL to have the best chance of getting AA granted for AD?”
Yes LBSR!!!!!! This is my exact thoughts on all the BS FUD being spread today!!
Ignore the noise. Rett approval and AD AA coming.
"no brainer" LMAO
Excuse my usage here, but accepting a reduction in excessive brain shrinkage as a new AD biomarker is a no brainer.
I would think one has to assume that the latest stats presented were primarily the work of Kun Jin. Therefore, is it too outlandish to believe that (of all people currently walking around on Planet Earth) Kun Jin himself knows better than probably anyone else what the FDA will want to see in order for AVXL to have the best chance of getting AA granted for AD?
It appears to me that Doc328 is giving it 0% chance...
FWIW - Here is a short list of the posters here that have proclaimed their thoughts on this:
bas2020 - 100%
Hoskuld - 100%
boi568 - 90%
Investor2014 - 25%
12x - 5%
Hopefully, you will be proven right within the next 15 months. One thing seems for sure...2024 appears to be the "make or break" year for AVXL. Here's to hoping they "make" it!
Anavex will be granted approval in both Rett and AD next year.
Out of curiosity, what % chance are you currently giving for AVXL obtaining AA?
[Hoskuld at 100%; Investor sitting tight at 25%]
FWIW - CTAD (Oct 24 - 27, 2023) Late Call For Abstracts deadline was last Thursday, September 7th...
Is there any way to dispute AVXL's assertion that "the trial was successful" based upon the following information they provided within their PR this morning?
The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.
I wonder if/when Soumit Roy will come back out with an upward revised price target since the blurb below came out about an hour prior to today's PR...
JonesTrading Keeps Their Buy Rating on Anavex Life Sciences (AVXL)
Sep. 14, 2023, 06:25 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 closed yesterday at $7.66
https://markets.businessinsider.com/news/stocks/jonestrading-keeps-their-buy-rating-on-anavex-life-sciences-avxl-1032630260
OK, just thought I'd ask.
By the way, Hoskuld at 100% - I like his prediction better than yours...hehe
No, but more content that ever with my 25% chance.
Here's to hoping your opinion becomes fact. If so, then it's red sparkly bicycles for everyone (except mike_dotcom) come Christmas 2024! hehe
IMO the slam dunk AA path made possible by effect on beta amyloid and brain volume biomarkers - both pieces of data were VERY strong. Would be very surprising if the FDA did not grant approval on these bases.
Based upon today's info, are you considering an upward revision to your "25% chance"?
Let's see AA is potentially within reach. I now feel exonerated for my generous 25% chance.
That's your reply to my post in which I simply stated that I received the PR directly from AVXL at 7:20am EST???
Man, you are a strange dude SMH
Man you must be part of the top echelon of biotech investors.
FWIW - AVXL #1 Top Trending Stock on Stocktwits this morning...
FWIW - I received today's PR directly from AVXL at 7:20am EST...
So, Investor, do you get an advance notice of Anavex's PR? The PR was released at 7:29 AM, EDT, and your lengthy post was printed on 7:30:48, less than two minutes thereafter.
Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows NeurodegenerationSignificant Reduction of Amyloid Beta Biomarkers of Alzheimer’s Pathology
GLOBENEWSWIRE 7:30 AM ET 9/14/2023
NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp.(AVXL) (“Anavex” or the “Company”) , a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did demonstrate a statistically significant slowing in cognitive decline associated with Alzheimer’s disease.
The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma1, as well as a significant slowing in the rate of pathological brain atrophy2 on MRI (Magnetic Resonance Imaging)3 scans.
The trial was a Multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia). Participants were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks.
All prespecified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM). The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation.
The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P = 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing treatment to placebo. In the respective safety population, common treatment-emergent adverse events included dizziness, which was transient and mostly mild to moderate in severity, and occurred in 120 participants (35.8%) during titration and in 76 participants (25.2%) during maintenance with blarcamesine and 10 (6.0%) during titration and 9 (5.6%) during maintenance with placebo.
“There is hope that new therapies for Alzheimer’s that target the disease beyond amyloid that may slow progression of the disease for many people with the earliest forms of the disease,” said Marwan Noel Sabbagh, MD, Professor of Neurology and Chairman of the Scientific Advisory Board. “The advantage of blarcamesine (ANAVEX®2-73) is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and excellent safety profile.”
This is among the first drugs to prospectively demonstrate efficacy on biomarkers of neurodegeneration.
“These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” says Michael Weiner MD, Professor of Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco (UCSF) and Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative (ADNI).
“Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide, and Anavex’s clinical development is a testament to our determination to follow the science,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We like to thank all the people involved in the study for their invaluable contributions and we look forward to advancing blarcamesine as a potential new convenient orally available treatment option for Alzheimer’s disease.”
Hoping to see you say "I see a BREAKOUT occurring above 28.20" sometime next year...hehe
I see a BREAKOUT occurring above 8.20
FWIW - 100fold's post on Stocktwits earlier this morning regarding his thoughts on the appointment of Dr. Marwan N Sabbagh, MD as Chairman of the AVXL Scientific Advisory Board...
100fold
10:14 AM
$AVXL Perhaps, this was the KOL Missling was referring to when suggesting the OLE was the confirmatory trial for accelerated approval.
Here's to hoping that your statement below is eventually proven to be correct!
As always, time (hopefully, not TOO much more) will tell...
The current OLE will very likely become the confirmatory trial, as Missling alluded, with establishment of AA pathway.
Certainly a possibility since we are sitting less than a quarter away from a new 52 week low 😔
The good thing is our chances of setting a new 52 week high by the end of 2023 and a new all-time high sometime during 2024 are fairly high...aren't they? 🤔
ANVS hit a new 52 week low yesterday, SAVA hit a new 52 week low last week - our turn today.
Sure as heck hope so! Would certainly turn out to be worth the long wait. And would be a much better level to springboard from if somehow Missling can pull off an AD AA...
Rett approval means many multiples of the current pps.
Congratulations Georgey on being Post #429000!
Would rather be congratulating you on one of your predictions coming to fruition, but history strongly indicates that probably won't be happening anytime soon. Oh well :(
What makes the day after Labor Day a great day to present the Rett TLD?
FWIW - Rett Syndrome Awareness Month is recognized globally in October.
Next Tuesday would be a great day to present Rett TLD
WOW! What a brilliant, insightful statement! Thank goodness you are here to keep us informed as to the current status of AVXL. YAWN...
Overall — technically AVXL doesn’t look good. But, right now, it’s all about the pending news
abew4me - It really is going to be quite facsinating to see if what you say below actually comes to fruition! Would be one heck of a call/prediction from you. It appears that you really believe that this is what Missling meant when he said "You will understand why we did what we did after we have done it" or whatever that exact quote was way back when...hehe
Yup. IMO, this is confirmation that Anavex will be repurposing A2-73 after it is approved for Rett...which is exactly what I had outlined in my previous post a few weeks ago. (See below)
*****************************************************************************************************
abew4me
Post# 426544
Wednesday, August 09, 2023
Yes. I think they'll present the OLE as an alternative to a full-blown confirmatory trial because their NDA (New Drug Application) will be focused on repurposing A2-73.
This has been Anavex's plan from the beginning (IMO)...but the Covid virus delayed the approval of Rett. Now everything is back on track!
Drug repurposing, or repositioning, is a strategy aimed at identifying new uses for already approved drugs, which fall outside their original medical indication. This strategy has led not only to the successful preclinical and clinical testing in multiple neurological disorders, but also to the reevaluation of disused drugs, epitomized by the remarkable case of thalidomide.
In recent years drug repurposing has covered a wide range of neurological disorders, from neurodegenerative and neuropsychiatric to drug abuse-related disorders.
Alzheimer’s disease and Parkinson's disease, for example, are the two most common neurodegenerative diseases, for which only symptomatic therapies are available, while neuroprotective drugs are still an urgent unmet need. They are therefore in the top list of neurological disorders for the investigation of repurposed drugs, targeting both the disease neuropathology and symptoms.
**************************************************************************************************
The FDA can approve an NDA (New Drug Application) with one successful P3 trial and the repurposing of an FDA-approved drug.
So, if the FDA approves A2-73 for Rett, that would qualify for the first half of our Alzheimer's application. The other half would be our P2b/3 AD trial.
IMO, this is the main reason why Anavex wants the FDA to approve Rett first. Once it is approved, they can expedite the entire process for our Alzheimer's application by simply repurposing A2-73. (Qualifying for the $100M voucher is a bonus)
Our FDA guys know what they're doing...especially Dr. Jin.
TGD and his team know what they're doing. Just sit back and enjoy the ride.
"Rett will bring $50 a share."
It will bring? That's a statement of fact. Let's hope you are right about that!
Of course, saying it may bring $50 or that it hopefully will bring $50 probably makes more sense during this waiting stage...
By the way, at what stage do you believe "Rett will bring $50 a share?"
Upon the release of truly excellent EXCELLENCE results?
Upon NDA submission?
Upon FDA approval?
Mike look at it this way. Rett will bring $50 a share. Take it and buy options.
So low to high $40's - that would be lovely...
1) Rett MC about $4B
2) AD Traditional Approval MC about $10B
3) AD Accelerated Approval MC about $6B
4) None of the above MC about $0.1B - $0.5B
Investor2014 - What share price and/or MC do you think AVXL can attain on truly excellent EXCELLENCE results? On NDA submission? On FDA approval?
Also, if you turn out to be delightfully wrong, what share price and/or MC do you think AVXL can attain?
But if it turns out to be deemed a P3 registration trial by the FDA for traditional approval, then of course I and some others will be proven delightfully wrong.
On the other hand if a P2b with or without AA potential with surrogate endpoint biomarker(s), then the endpoint judgement criteria falls more to the wayside as a lesser issue. I and a few others will the been proven correct that it was not a pivotal P3 meeting all endpoints for traditional approval. If we then in fact achieved AA I will also be delighted.
I certainly hope those estimates turn out to be low!
However, IMO we are not going to get anywhere near the MC bumps that Biogen got in the past. Of course, it goes without saying that I would love to be wrong...
IMO, low estimate....
Funny how Biogen goes up $20 billion MC on announcing the restart (3rd time) of a phase 3 trial.
This A2-73 is potential for real relief not just slower decline of life.
OT from NWBO iHub Board: Hilarious how Smitty5150 can post what he did earlier today and claim to NOT be the infamous Fireman...LOL
"The best I have seen, and took part of was 650% in 3 trading days but have watched other, which I did not own surge 800-1000%. I was in 3 years early but netted 3500% on that position." - Sure as heck sounds like Fireman to me!
Smitty5150
Re: Maverick0408 post# 624683
Friday, August 25, 2023 3:02:53 PM
Post# 624718 of 624729
I am not forced to do anything. I buy because I want to based of massive amounts of due-diligence. I "watched" NW for 3 years before my 1st position and did not got about it blindly. Anyone claiming with distinct certainty when events will happen with pre-rev biotechs are being deceitful. Its a very tough industry to invest in, but the winner always make up for the losers...if you pick the correct winners. Timing is tough, but the cash I have invested here doesn't need to be touched for a very long time, so the ups and downs have only allowed me to accumulate more, at a cheaper price and take me out of short-term Cap gains, which can decimate ones profit margin come April.
Investing is all about buying stocks that WS is mis-pricing at that point in time, not the other way around. They (WS) get it wrong sometimes, which is why it isn't uncommon for pre-rev biotechs to surge 300+% in a single trading day. The best I have seen, and took part of was 650% in 3 trading days but have watched other, which I did not own surge 800-1000%. I was in 3 years early but netted 3500% on that position. Where was WS before the rise? Mis-pricing, as they do on with pre-revs. Biotech is a tough nut to crack, for both retail and WS. But we have a winner here with NW. SP appreciation will take care of itself in due-time. And you Mr. Maverick, will be long gone, along with your "Fireman" references. Thank god, as I dont even like being around campfires.
Best of luck.
Wow, that's exactly what Fireman said he made in AVXL back in February 2021. How crazy is it that you made the exact same gains over the exact same period of time. Was the stock AVXL for you too...or some other stock? Nah, no way you are Fireman...LOL
The best I have seen, and took part of was 650% in 3 trading days but have watched other, which I did not own surge 800-1000%. I was in 3 years early but netted 3500% on that position.
Definitely a minimum of mid-$20's to low-$30's on outstanding Rett EXCELLENCE results (with hopefully the establishment of a new price floor at no less than $18 - $20 range; this single digit price level is beyond annoying by now...hehe). $30 - $50 range on AD results with clear path to NDA would put AVXL around a $2.5B - $4.25B MC and $50 - $80 range on AD + partnership with money would put AVXL around a $4.25B - $6.5B MC. These figures seem reasonable. Now we just need them to get hit LOL
I see Rett = 20-30 post Rett results (would be disappointed with less than 20), and 30-50 on AD results with path to NDA clear, and 50-80 if partnership announced with money attached. What are your expectations?
What potential valuations do you envision AVXL attaining (based upon approx. 85M O/S) if the "surprise" relates to
1) Rett alone;
2) Rett and AD; or
3) Rett, AD & partnership announcement?
...and 3) he wanted shares because it is possible that not only will Anavex surprise the market...but the market could also surprise Dr. Missling and drive the appropriate amount of value into the shares at any moment.