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Sandra is too funny stating fours years of cash on hand. If avxl ever comes close to filing an nda for Rett, just the ramp up towards commercialization, marketing and staff needed will, in my humble opinion, take half of whats on hand in one years time!
oh please stop it... Sandra Boenish is a Principal Financial person, not listed as management on the company's website. She is very important to Anavex at this time yet is not an accomplished CFO with years of experience in the biotechnology space. Missing is the financial expert steering the ship. Will Anavex need an experienced CFO in the future, i am not sure as I for one believe they will be acquired.
This is a non issue and imho over reaching!!
Isn't this exactly what AI and precision medicine is doing, taking us out of the dark ages in discovery...
Yes, 20 more months IS TOO LONG 98bemer!
Once this Sigmar1 platform gets going (first approval), imagine the speed in which the pipeline comes to fruition. Take the change in Avatar as an example, adapting to more rigorous measurements and converting to a phase 3 trial. Now, one can get anxious, of course, at this stage, being on the verge of a first NDA. Man, I can tell you I am one of them, but one look at the generations that exist within this therapeutic, I can't help but feel the excitement that Missling expresses. Yes, promote Kaufmann and Hammond. It's been a long road, taking what I interpret as very careful steps along the way. I mean, why wouldn't you if this breakthrough held so much promise. I can say with certainty that in three months, the Alzheimer's trial will complete, wow, we are close!
One more tidbit as i am in Manhattan... the recent move puts us even closer to Pfizer Headquarters
it's always darkest before the dawn, there, that sounds good!
... all of above imho
... maybe not this time. We have the reputations of well respected lifetime career professionals, Fadrian, Hammond, Kaufmann on our team and the tweet was slanderous, imho to Anavex. The changes in the trial design made it more rigorous to achieve a positive outcome. I would be a little worried, again imho, if I were AF...
... and they are referring to social media, AF's tweet as their basis, too funny!! I am not sure if he would want this type of attention at this time. I'd start to worry, inho, if that was my tweet, lol...
concise, to the point, correct in my humble opinion and could not agree more and with you D-Mike / Mac yet this clearly is not over until the volume settles down...
let the data speak for itself, let our seasoned fda staff do their job, let Missling steer the
science through the process (discussions with the agency are happening)
File the NDA for Rett with the designations and an accelerated approval will change everything...
others should chime in, Cantor Fitzgerald, Jones Trading, BTIG, Dawson James, Ladenburg Thalmann on the heels of the Avatar data
C'mon JP Morgan (fingers crossed), initiate coverage with a strong buy and $55 price target (pretty please)!
thx Powerwalker!
Today was a great day for the popcorn, lol, but I did manage to make a small buy, 50 more shares at a lucky $11.11
100% agree also.., and feel pretty good about the call today!
Just release the data, and nothing but the data... no beating the drum, well at least
not until we have the Alzheimer's data...
I do believe that Missling has a clear picture of the science, platform and is treading carefully...
my favorite part of the call was at the end of the q & a...
Missling adds/states in response to a question that there is a "strong picture"
at the higher does regarding biomarker effects, higher gaba/lower L-aaa are
applicable to diseases beyond Rett, same pathology, imbalances of other spectrum
disorders such as Fragile X, Parkinson's, Alzheimer's....
I believe they are on to something here!!
Houston, WE HAVE A PLATFORM!
I have said that El Doctoro is def holding his cards close but, in no way shape or form does he have any reservations about revealing what avxl has, yet, is "absolutely making sure" that the data speaks for itself. Compare Missling's understanding, conviction from the JP Morgan presentation to lets say a presentation of two, three years ago, pick anyone. This is a journey of discovery and much has been learned along the way. Hey, this breakthrough science business isn't easy, yet it never ends, and we are getting very close to late stage data readouts in human trials. He says that they are very excited at Anavex and I would think that anticipation of success extends throughout the organization, especially with our NEWLY promoted CSO and CMO.
Future plans, c'mon man, look at the pipeline, plus the plans for a preventative trial for pre Alzheimer's candidates... the future is well defined, even with the one undisclosed indication.
It would be great to receive some more attention from Mr Market, perhaps new coverage from the likes of a JP Morgan. Expectations of any good faith from the stock market will only add frustration. Just present the data, the whole data, and nothing but the data. The demand for shares should change dramatically in a few days (my guess is 2/2/22 for the Rett data) and in my humble opinion will continue throughout 2022. I'm feeling pretty good about knowing what I own. Keep the positive results rolling, I believe we have a fairly big readout later this year, and all should fare well here.
2/2/22 Groundhog Day, Rett data is pr'd, it's just too dang appropriate. There, I said it and am sticking with my prediction (a first, btw)...
...a man who know's sumpthin' about sumpthin' about what he knows might say: "Thar's gold in them thar hills, and there's millions of it"
Don't forget about"Tayo", Dr Emmanuel O. Fadrian, SR VP of Regulatory Affairs, very well suited for working with the agency on guidance...
I hope so also... from the June 21, 2021 Rett data release:
With this convincing biomarker correlating efficacy data of U.S. Phase 2 (ANAVEX®2-73-RS-001)7 study in adult patients with Rett syndrome, Anavex is planning to meet with the FDA to discuss the approval pathway. There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome and may be considered for accelerated approval. The study was supported by the Rettsyndrome.org Foundation.
let me chime in on the two recent promotions:
Kaufmann, what a great well deserved career achievement. We all know his credentials!
Hammond: Dr. Hammond, who brings more than 15 years of exceptional expertise in clinical drug development, including the approval of medicines and beyond, previously worked with the Astra Zeneca Group, where he took on increasing responsibilities including Head of Epidemiology Center of Excellence and leadership for established brands, and for life cycle management within the respiratory franchise.
“We are thrilled that Dr. Hammond is bringing to Anavex his strong industry and operational leadership at a time when our two oral, first-in-class product candidates are advancing in the clinic,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Dr. Hammond has deep experience in drug development, including rare diseases and increasing chronic diseases of global burden and importance, which will prove valuable for our clinical development and registration strategies. His career-long focus on robust and innovative clinical trial design and execution to improve the quality of patient care is an excellent fit with our vision and culture, which is dedicated to making a fundamental difference in patients’ lives.”
“I’m excited to join Anavex at this time of important growth and evolution of the Company,” said Dr. Hammond. “Anavex is a leader in the investigation of precision medicine in the field of CNS and is rapidly advancing several promising oral medicines to treat a range of serious diseases. Together with our experienced leadership team, I look forward to helping Anavex continue to accelerate the development of our pipeline and bring innovative new medicines to patients.”
Dr. Hammond, who joined recently, is a Physician-Scientist, Clinical Epidemiologist and Public Health practitioner with exceptional biopharmaceutical industry and academic expertise, encompassing strategic understanding for drug development and proven leadership. Dr. Hammond has successfully conceptualized and implemented several early and late-stage clinical trials and been involved in successful drug development programs with approvals in the US and globally. Dr. Hammond’s focus is on an integrative, innovative, and efficient drug development continuum for which he has exceptional expertise spanning drug discovery, translational medicine, clinical trial design and analysis, medical affairs, pharmacovigilance, health outcomes, value propositioning and access strategies to facilitate deep understanding in support of drug development and post-marketing activities. He has published over 60 full scientific manuscripts and book chapters and served as a reviewer for several medical journals.
You don't promote these two and then deliver less than stellar results (imho)...
... ahhhhh, good reply Raja! I do not expect this 25 employee team to beat their drum and push around big pharma with huge pr's, so, yes, waiting has become a necessary evil. Nothing has changed with being patient over the years, except, if you take a "good look" at the pipeline progress, a lot has changed!
Missling has been stealthy, steadfast, imho on purpose, navigating this paradigm shift of discovery bringing a big change to drug development. Did I hear the preparation of a basket trial in the works?
So, with stellar results in the bag, they will walk, dot all i's and cross all t's and work diligently with the agency. Yet, we are just at the point where the next data readouts can really accelerate the science here. I for one have my popcorn ready to watch how 2022 plays out.
You should get your answer as, imho, we are definitely going to get an update regarding correspondence between the agency and avxl in the data release guiding the regulatory pathway to approval. With stellar results, this would be the time (again, imho) to receive BTD, which I am sure many here believe the Rett platform has earned and what Anavex is proving out in multiple cns trials, a breakthrough therapy.
100% imho agree Fireman... There is something brewing... Missling is keeping his cards close!
$20's would be great in this market environment, it corrects the chart and I imagine we could get right back there with stellar results, add in some shorts covering. It also sets for the next leg up, $40's as we approach Alzheimer tld later this year with plenty to come in between. Nothing, absolutely nothing has changed here and looking forward to a robust 2022 as this "burgeoning science" continues onward...Missling has avxl in a strong position.
Oh man, Can you imagine if Anavex was running low on cash! With a five year runway, I can sit back and watch the science play out, which will be quite exciting later this year upon the Alzheimer's readout. I take the multiple dsmb nods plus the extremely high rate of rollover into the extension study as a very good sign These patients, their caregivers and doctors know a heck of a lot more than we do. In the meantime, If CM wants to hit the Avatar readout out of the park, and possibly pr any headway we are making with the fda, plus start new trials, that's fine with me. I'll bet there are suiters in the wings licking their chops over that pipeline! I'll keep the popcorn ready...
Good science wins.
Give it a break will you!
Employees:
Biogen - 9,100
Gilead - 11,800
Pfizer - 78,500
JnJ - 136,400
Anavex - 25 (and they are a little busy!!!)
... don't look now, it's been six months since this happened, but mrns just decently broke through their 50dma
...things have changed!!! For the first time in 8 months I do believe my trading stock, in 3 days, the very rewarding 5 calls (been writing every month since May) should be called. I will be astounded if they expire worthless. I believe the shorts are trapped now. Only way they do not get taken in my humble opinion is if Missling strikes alongside this strong data with a capital raise. If this happens I would guess Cantor and about a 60M offering. Yes I said 60M. Anavex is now, again in my humble opinion, at a stage where they will not wait very much longer to fill the coffers. Congrats to Kaufmann, Missling and all longs. Best, flsh56
things that make me go hmmmm (and worry me a bit)...
Did Missling put the cart before the horse with PDD (which are not early diagnosed PD patients
if I am not mistaken as we are looking for in alz disease) ...
How many of the eligible patients opted into the PDD ole... Misslling said 100% but my best guess is
around 33 patients qualified- this info will tell me a lot when learned!
That whole alz compassionate use PR was a bit missleading....
Does Missling have too much power (where is our CMO on Rett news)?
will we be anywhere close to filing an A-273 NDA for Rett with all the FDA awarded designations after the next two readouts (which are supposedly close by)? If so, why are we not increasing staff and awarding inducement grants?
is there a partner anywhere in sight ?
you have to look back a bit to look forward...
I am fully invested, been here for over 5 years and it looks to me that starting January things will get interesting again. i am bracing for impact, I mean PDD results... Hope i am pleasantly surprized
.. ya know, pioneering a new precision, AI, biomarker driven approach to discovery of medicine, especially in such an unmet area, where failure has been witnessed for decades, and producing positive results across the cns space from the young to the elderly in the clinic with A-273 & eventually A-371, and doing so without some learn as you go understandings, potential for intermittent dosing etc etc etc has kept me here for over 5 years. They do this correctly, validate the science, and the future of their trials will only garner more acceptance and credibility.
If we are truly witnessing a successful paradigm shift in the way clinical trials will be structured, to predict better outcomes and speed up discovery, well then I for one do have a few more years of patience...
I have expressed some of my concerns that I have with Missling recently and hope that he includes
the voice of our foremost expert in Rett, who joined our team as CMO, BE HEARD on all related accomplishments going forward.
.. and so we wait on the really "first clinical milestone" for Anavex Life Sciences, The PDD readout.
... good luck to all
... well I like your call on that, and if it pans out, my trust in Missling will get a little stronger
wow, that in my humble opinion would be a "dream case" scenario basparks79 and would again in my humble opinion send the stock price flying!!!
Missling said 100% of those patients that "qualified " for the PDD OLE opted in.
I have no clue or even have had any indication of this number from anywhere. Are you speculating or have some evidence of this over 90% figure?
I think that number is going to be much lower but enough to keep the valuation going steady until the Rett readout. The multiple Rett readouts, which will hopefully be strong should validate this platform and send the stock price towards the insty's targets.
i have had a lot of patience in arriving to where we currently are. I have more to last for the next readouts. More validation with Rett and things get really exciting around here with the depth of the Alz trial. It's been a long ride so far and hope my trust in Missling proves correct (It is just not death and taxes)...
Leave it to Missling's guidance of mid year to mean the very last day or two of the 3rd quarter!!
I totally believe in the science but to trust Missling 100%, not me, I've seen too much over the years.
Just a few easy questions I would like to know the answer to:
How many patients in the PDD trial went on to the OLE... 60, 50, 25?
Why oh why do we have one of the foremost experts in Rett as our CMO and not include him, some comment from him, spotlight our brilliant team, in a very important pr about completion of a Rett trial??
Does Missling have too much control? I do not know but until we finally get some validation of the science that will go unanswered.
I must say that after being invested here for over 5 years, I've learned a bit from him and it's been a nice ride for me this summer. Missling promised PDD results, from a very important trial, mid year and the 5 calls had that potential for positive results priced in. They were too attractive not to sell. Collecting the premium and keeping half of my holdings for June, July, August and now September was really compliments of Missling. The other half of my holdings are a core position. I have now moved on to the january 5's. I believe the PDD results will be good enough to keep our current valuation until the next readout for Rett. By the way, I am very happy to finally see avxl hold a valuation of 250M for some time now. All it did last year after June was go down. That in and of itself gives me confidence.
Lets see just how bonkers this stock will trade upon PDD results. The new biotech space lends me to believe we will trade over 100 million shares.
Good luck to all longs!
careful with that one Tred... I for one am leeey or lets say cautious about the statement Missling made stating 100% of "eligible" patients that "qualified" for the open label extension study opted in. I for one am also hoping that figure comes in above 75% but believe that is wishful thinking. If it is under 25% then we could consider the Missling statement as spin. The caveat is even if a small percentage of the trail population has a significant biomarker response and went over to the OLE, that could be the results needed to plan for the next phase (3?) for PDD.... I believe we are in for some type of a good readout, fingers crossed...
... after all this time, about 5 plus years, and on the verge of an important trial readout, at this point have nothing but to trust Missling. My question is why we haven't heard from our CMO at any conference or even at the shareholders meeting? Why couldn't Kaufmann have commented on the last pr regarding the completion of the Rett study. Isn't he the top expert in the field? Its always Missling. Anyhows, it will be very interesting to see just how many of the PDD trial population qualified for the extension study. 100% of those who qualified did opt in according to Missling. Hopefully well over 50%!! We will find our shortly.
on another note, for all of my fellow posters here at avxl over the years, I wanted to trust Missling explicitly but have taken half my avxl holdings and went into mrns Marinus Pharmaceuticals. I have been following them for a few years. Their top line readout this week met endpoints and they have a pipeline for a serious unmet medical need. This is where I always applied my focus in biotech investing. Some who know me may recall Amylin Pharma (what a ride that was). All brokerage firms covering mrns raised their price targets and they are over 70& institutionally owned. They plan to file an NDA in first half of 2021 for the indication they just pr'd on Monday. They received Rare Pediatric Disease Designation (which carries the voucher) from the FDA for this indication just this past July. They are growing, hiring (up to 42 employees now). They will probably sign a partner in my humble opinion and feel they are also a target for getting bought out. My take is they gain traction with the FDA, advance critical areas of the pipeline and the share price will continue to take care of itself. Most all of my shares were bought under 2 bucks. If they just validated their platform with the results posted this week, well then this is not a bad time (high 2 / low 3 dollar range) to get on board. Please do your own dd and good luck to us all... best, flsh56
Russell Rebalancce?
I believe he mentioned Anavex received the US equivalent of Orphan Drug Designation from Europe for Rett
yes, after double checking I believe you are right Indialong
I jumped the gun after reading this:
The following table shows the largest shareholders in ANAVEX LIFE SCIENCES CORP COM (AVXL) for the quarter ended June 30, 2019, listed by holding size. The list represents up to 50 of the largest holders in the company.
Looking at the entire list there are only a few companies reporting for 6/30 with most modestly increasing their position. Guess we have a few more days until nasdaq reports.... sorry
Dow Jones Newswire, on avxl news page on my Bank of America account...comes across every quarter:
Dow Jone newswires
Related Investments
Anavex Life Sciences Corp
Last 3 Months
chart image for Anavex Life Sciences Corp
The following table shows the largest shareholders in ANAVEX LIFE SCIENCES CORP COM (AVXL) for the quarter ended June 30, 2019, listed by holding size. The list represents up to 50 of the largest holders in the company.
Note: Unless otherwise mentioned the reporting date is 06/30/2019
Institution Shares Shares % Last
Held Changed Held Report
Park West Asset Management LLC 3,495,615 0 6.935 03/31
The Vanguard Group Inc. 802,210 171,389 1.591 03/31
Knoll Capital Management LP 724,205 0 1.437 03/31
Susquehanna Financial Group LL 337,525 212,588 0.670 03/31
Geode Capital Management LLC 328,848 36,900 0.652 03/31
BlackRock Fund Advisors 217,664 292 0.432 03/31
Shigeta Yasumitsu (Investment 174,080 26,000 0.345 03/31
Barclays Bank Plc (Private Ban 117,500 117,500 0.233 03/31
B. Riley Capital Management LL 115,000 115,000 0.228 03/31
Northern Trust Investments In 111,372 (122) 0.221 03/31
You can understand why I can't provide a link to my account
Its accurate!
Top 10 institutional holders as of 6/30/19... most added:
Park West Asset Management LLC 3,495,615 0 6.935 03/31
The Vanguard Group Inc. 802,210 171,389 1.591 03/31
Knoll Capital Management LP 724,205 0 1.437 03/31
Susquehanna Financial Group LL 337,525 212,588 0.670 03/31
Geode Capital Management LLC 328,848 36,900 0.652 03/31
BlackRock Fund Advisors 217,664 292 0.432 03/31
Shigeta Yasumitsu (Investment 174,080 26,000 0.345 03/31
Barclays Bank Plc (Private Ban 117,500 117,500 0.233 03/31
B. Riley Capital Management LL 115,000 115,000 0.228 03/31
Northern Trust Investments In 111,372 (122) 0.221 03/31
My guess would be Biogen but Pfizer (who's hq is only blocks away) has to be paying attention.
Someone here who attended this years shareholders meeting posted that Missling would be buying again from a conversation they had. I believe he posted that his comments were "wouldn't you at these prices"... That was back in May!!
Now considering that the same time period/window that Missling made his purchases last year has now passed, be interpreted as potential negotiations could be taking place. If this was the case, is it not true he would be restricted from buying?
My opinion is a licensing deal, quite possibly on the MS front could be close.
I will chime in on this topic...
my belief is on the contrary, If shares are desired, this is an opportunity to pick up big chunks as what is held by index related funds and released will be scooped up... look for a rise in the share price if and when this happens
This is really not imho a "hope some big news happens before" event as long as all of the pieces Missling has in place execute accordingly to the timeline guided...
awesome post Bio...
...best I have ever read!!
I am shocked, shocked that Avanex has run into a delay initiating the trials...
Who knew that pioneering a promising new scientific approach to diseases that big pharma has failed and failed again, even recently abandoning the space, alongside a paradigm shift in clinical trials targeting a precision design which will change the face of all future clinical trials, even strongly predicting the outcome of later stage trials, and advancing such through new (but previously 2017 expected) CNS guidelines from the FDA which now finally released would seem to fit exactly into the Anavex wheelhouse, would run into such challenges!
The market has justly as one would expect in old school thinking, with the whirlwind of uncertainty created which leads you to question everything, and in its most volatile way punished the share price for running into these challenges. Perhaps, and in my own humble opinion, the market has no clue how to value the Anavex platform. Perhaps the picture will become clearer on the initiation of the Rett trial which I believe, with the agency endorsement, will potentially reveal the challenges that were incurred.
I am sure Missling needs to tread these uncharted waters very carefully especially with the FDA...
Someone posted Maxim changed their price target to 5 dollars. I will welcome that in the 2nd quarter on the start of the Rett trial. They will have the opportunity to revise upwards in 2018.
Some posts here and on other message boards would have you think that Missling has duped the MJFF, The Australian Government and even the young children's money of the Rett org. How preposterous!
This long is just patiently waiting for multiple executions in the revised plan timelines (this change, in reality can be considered only a few months, a quarter or two, not very long in the evolution of medicine) and the reversal here can be quite dramatic...
investing 101?
waiting for a data readout on the horizon of (new world) precision medicine clinical trials in my opinion will cost you plenty...
I have speculated/invested in the baby bio space focusing on unmet medical needs alongside breakthrough science for over 25 years and do appreciate an (old world) conservative investment approach.
pioneering science / pioneering investing