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blarcamesine, the best of the bunch firetruck.
Made me chuckle, good summary.
The incompetence continues ... but hey they hired another "interim" CEO.
FORM 12b-25
NOTIFICATION OF LATE FILING
https://www.sec.gov/Archives/edgar/data/0001451512/000147793222006139/unrv_nt10q.htm
LOL..or like a new Prevagen.
Your comment reminded me of that bryostatin stuff, whatever happened to that compound? I think from Neurotrope, then Synatogenix.
General question, btw, not direct to you gator. ;) unless you remember that story.
Very exciting stuff on the Rett front, how it's all filed with the FDA is still up for debate. We've learned how trial parameters are definitely important, as shown in the measurement debates with RQBQ-AUC versus change from baseline.
On the rare disease front in general, trials should be starting soon. Oh and the "mystery indication"...
Anavex has ran as large of trials as they had funding for. There was no "messing up", and only since the 2021 capital raise has $AVXL had a decent cash balance to run larger trials.
Also, regarding Rett, "I think he finally realised that he needs larger cohorts and this is the true reason behind expanding the Excellence trial." I doubt Dr.M "finally realized" anything...it's the public that are the ones finally understanding what has been done and why.
"The two upcoming readouts will be the endgame for 2-73 IMO." ... yes very much some put up or shut up moments ahead.
Truth bombs with high effect on target!
"We may approach 100M by the time we secure a partner and/or have an approved pathway. Need to give TGD credit on this!!"
I agree!
The other issue is scientific integrity and time wasted.
Just venting my frustration and looking forward to new MOA's such as S1R and muscarinic modulation.
"Experts in this area ... can spot scientific fakery. And they have spotted a lot of it at SAVA."
It only took the "experts" 16 years to overcome their bias to look for it.
True fact, but it's what keeps people interested.
Remember, if there are juicy tidbits to be had, those parts would be embargoed to ensure compliance with regulation FD.
Wrong, the point is investors should understand that these are "forward looking statements" given it's biotech and NOTHING said are "promises".
You know the giant disclaimer on EVERY corporate publication.
That's a very boring logical non-inflammatory thing to say and 100% correct.
If we could just get these damn sick kids to co-operate with the corporate timeline, that sure would be nice....
Anavex definitely has a story to tell and how it's told could have an impact. Your potential timeline has a fairly good chance of being correct.
In the meantime, Dr. M and crew has intrigued me with their ventures into rare diseases, and I wonder how does the study of these very specific caused rare diseases, contribute to the whole of our understanding of S1R and muscarinic science as it relates to neurology and by extension all dementias?
Also, I think the PDD OLE data will also reveal in that analysis that there were PDD patients misdiagnosed as Lewy Body Dementia patients and the data will further open up the possibility blarcamesine and 3-71 will broadly cover many dementia indications.
Very informative, highly recommend for those interested in dementias. Her testimony is nearly identical to my experience too.
More coverage here: https://www.cnn.com/2022/07/01/health/lewy-body-dementia-robin-williams-life-itself-wellness/index.html
Lewy Body Dementia and PDD are extremely similar in clinical presentation. It will be exciting to get the full data set analysis. I bet blarcamesine is effective for both.
My dad was initially diagnosed with PDD, but in the end it was actually Lewy Body Dementia.
The 2 broad areas I'm excited for blarcamesine being effictive in are seizures (Rett) and dementias (PDD, AD). Seemingly disparate diseases to most people right?
The solutions are upstream and that's where $AVXL research is heading.
I said capital flows, as in money moving in and out of an asset class or sector such as biotech and the $XBI. Your comment refers to a companies need for capital for operations a very different concept.
$AVXL has enough capital for approximately 5 years.
They got this (wink..wink), it's capital flows that still matter in the meantime. Is the tail waging the dog in the $XBI?
Why, to make sure they set their alarm for tomorrow? LOL!
Nope, caveat emptor suckers.
Indeed, and special thanks to everyone involved in the trials process.
Dang, from OTC to top tier NASDAQ has definitive made for some great market entertainment over this long, long journey.
Only trial results matter now, and smartly $AVXL will present an R&D exhibit to bring the new crowd up to speed.
"out of nowhere... Cinderella story" LOL!
But seriously, $AVXL now has a broad Sigmaceptor platform that has shown clinically meaningful positive results in trials AND biomarkers to put on display, tying together the entire S1R / Muscarinic receptor possibilities across multiple indications into a coherent package digestible by everyone.
Do we go mega long on a trend line break and hold over $10?
Can $AVXL do it with or without biotech sector participation?
Discuss...
The low number of participants and its drawbacks will always plague post hoc evaluation of $AVXL. Those familiar with rare and ultra disease drugs are used to this drawback and have to look at other factors to weigh the value of the data.
Good questions and as more data is accumulated $AVXL will have more answers.
One of the biggest lessons of life is to learn to say "I don't know", then find out about it. $AVXL is the biggest "neutral" bet of my life as it's science.
Also,in disclosure I have a very low cost basis hence my lack of complaints.
On that topic of learning. I've used the barbell strategy the past within specific accounts to mix T-Bills with Option strategies with maintenance requirements, and I noticed the similarities to the allocation I've almost completed after 2 years of work to move one notch conservative on investor profile type recommendations.
Now back on topic, I too hope to get access to blarcamesine ASAP as I can feel my brain getting hiccups with a long way left to go. Plus the new buzzword gaining traction is Mild Cognitive Impairment to freak us out when they have no solutions.
And, I am on team "sleep, nutrition, and mindfulness" as a lifestyle to prevent cognitive decline as long as possible for those debates as they pop up. ;)
MJFF is ready to step up with cash whenever this happens.
"Strikes me that the Parkinson's imaging study may also be useful to elucidate how dose relates to S1R occupancy with A 2-73 in humans and related to that how and when mRNA overexpression of S1R may be reached."
and to comment, I guess homeostasis is complicated and overexpression and/or decreased expression with age are both bad.
There's some feedback from anyone. ;)
I had friends and relatives take profits when Missiling and Sandra exercised and sold in the $26-$26.50 range on June 29, 2021.
Bully for them in retrospect, and of the small amounts of insider sales to review, Dr. M and Boenisch definitely got lucky and hit the peak frenzy of the AD shiny object driven high trades along with its AD peer group of stocks.
$AVXL is one of the few "risk-on" positions that I maintained even when I moved all of my portfolio allocations from "aggressive growth" to "moderate growth" to better match my post retirement investor profile.
I have rarely had less than a 95% equity allocation for 25 years, so venturing into fixed income for a 10-15% allocation when we all know rates are going up remains a challenge factoring, but I buy and hold until maturity and am currently using short term t-bills. BTW, I adamantly hate fixed income, but sometimes capital preservation as an objective forces one to change their style. That's not easy for me as a ex-market risk analyst and very active trader, but as I age I'm mellowing.
As such, I have in a way created a barbell or "dumbbell" strategy. That's a portfolio with a mix of a super conservative holding like a t-bill matched off against a risky position like $AVXL or options. Funky strategy, but the risk/reward analysis balances out.
$AVXL is definitely in the "red zone" in that they are one of the last of the AD shiny object plays like $SAVA, $CRTX...etc. to present data to succeed or fail.
Perfect observation. Missiling has been playing the "long game" which I prefer versus a pumper CEO's like $SAVA's Barbier
I guess all biotech CEO's are playing this game...
and I guess every CEO in biotech has been " keeping the stock price down."
LOL... yeah it's the CEO's fault for every biotech stock being down.
Those of us well seasoned in market dynamics have been saying for a long time now as goes the sector, so goes the shares. That is until a company specific catalyst changes this dynamic for the single stock to diverge from the index.
$AVXL is a stock with very strong potential in an out of favor sector. I've played similar set-ups in other sectors for huge returns.
I guess every CEO in biotech has been " keeping the stock price down."
LOL... yeah it's the CEO's fault for every biotech stock being down.
Those of us well seasoned in market dynamics have been saying for a long time now as goes the sector, so goes the shares. That is until a company specific catalyst changes this dynamic for the single stock to diverge from the index.
$AVXL is a stock with very strong potential in an out of favor sector. I've played similar set-ups in other sectors for huge returns.
Good question and the data from the larger sample sizes of the AD and PDD trials should help answer these dosing and titration questions.
Screw "cautious optimism", I've been in that phase for 6 years. Personally, it's time to let some of that positive anecdotal emotional energy to take root on $AVXL.
"We got this"...LOL!
I noticed this language in the patent application:
Good point, didn't think about it that way.
"And here is where Missling's control of the BOD with university drinking buddies would work to our advantage. Missling will not give up the company, certainly not now."
On that topic, this is an amazing statistic.
Big Pharma Has Enough Cash to Buy All of Biotech. Why M&A Isn’t Happening.
https://www.barrons.com/articles/big-pharma-mergers-biotech-cash-51651844327
I betcha a positive readout will get BP stalking $AVXL.
I hate the fact the proof comes at a historic low for the $XBI biotech index, and big pharma companies are flush with cold hard cash to swoop in and buy valuable assets on the cheap.
$AVXL's poison pill be damned, if BP wants and asset in this environment they have the cash to convince many boards of directors to take the deal.