Explore small cap ideas before they hit the headlines.
Explore small cap ideas before they hit the headlines.
Partner yes but theres no way we can sell the company or drug at these levels. That would be the ultimate screw for shareholders.
Yes, this is a great point made in any correspondence with IR. When will we follow up with another trial, PERIOD.
Ive followed and maintained composure during many, many up and down cycles, too many to count, but Im growing a bit impatient. With this paper and the myriad of other 3rd party peer reviewed papers this product needs to be put on the right trial “track” for approval for patients and shareholders. There is no other option imo.
Big investors coming in, great presentation yesterday and the stock tanks on what, sector weakness? Im not sure whats going on but the fundamentals are good here.
Skip the conferences outside of the ones needed to advertise the trials. We know the science, pack the trials and maintain creative moves that keep the coffers full. Expeditiously realistically, what 2+ years?
After all the recent management developments the only important reveal to me by the new CEO is our path forward with regards to trial rollout for our pipeline. VP’s will come and go for various reasons, minor lawsuits will come and go as well so to pull out all your hair at either announcement is investing with too much emotion.
If our new CEO can effectively communicate timelines, keep who is needed filling the gaps, and stick to them then thats a first good step. Upon a firm footing being established, ie no major lawsuits or scandal, just get the large ph 3 Alz started for heavens sake, the world needs it now more then ever.
Now and for the next few quarters is a good time to underpromise and over report.
FTR I trimmed a few to get ahead of the next gold run. Still long and strong with 85% of my shares.
Buckleup buttercups.
https://anavex.com/team/axel-paeger/
I wonder if there is a connection between this Dr. whose company cares for 10’s of thousands elderly patients and a possible benefit for enrolling a 1600 patient phase 3 AD trial. Obviously you would like to see a multi continent and ethnically diverse population.
On another note any change in capital raises from the historical trickle feed will be closely watched. If we change to the traditional bloated dilutive secondary funding mechanism to satisfy the BR, SS, benefitting an eventual buyout partner I think this will signal a buyout plan.
“ will run out of posts soon.Missling is as Alwats one step ahead.Europe trapped him ina fools errand.I don’t blame him, but he FDA is corrupted beyond hope.”
There may be some truth behind this, we may never know but one thing that is for sure is BP’s tentacles run very deep and the almighty dollar has a certain allure to people of questionable character.
Dr Missling had his decade to get the drug to market in at least two different conditions. He failed in both but as a side note Anavex did survive the pandemic in financinv and maintaining recruitment.
All things aside the almighty one is always present and if it was His will we would/could be to market in a flash.
Ive been here since 2015, no sense in not seeing the science out.
Tred
EMA didnt see all the data. If they can package ALL the data in an NDA including the brain preservation data together and run a safety trial I say go for it. Waiting 2-3 more years is too long of a wait to ask for patients and shareholders.
Dr. Missling will be very careful on his next trial move. At least he has the biomarkers and dose data which together can be used to design a bullet proof trial.
As shareholders, we are entitled to hear the outcome on the type C meeting with the FDA.
Is it any surprise that this “kick in the nuts” comes with a 73-80% institutional ownership? Also, take a wild guess at the top two holders?
We will be approved when BR and Vanguard are at the top of an 80% insty ownership imo.
Thank you hnbadger1. These slide decks are unimaginable in an Alzheimer trial and yet here we sit with another 3 yrs of trials needed.
This is one time where I pray Dr. Missling under reports and over delivers.
Vitamin D is so important in all of our body’s daily functions. Vitamin D comes naturally from our bodies being exposed to the sun during important times of the day, ie ideally 1 1/2 hrs at sunrise and 1 1/2 hrs at sunset. Every cell in our body is “programmed” by the sun keeping our circadium rhythm in check. Quit taking vitamin D pills when your Dr. tells you your deficient and expose yourself more to the natural form.
Below Dr. Alexis Cowen goes into detail about it even though the topic is on mold. Its a truly transformational rabbit hole of health. You will never look at “tanning” in the same light, no pun intended.
Tred
Black rock
Black rock
Thank you K9uwa. They will continue to be a barometer, when BR sells you know the gig is up, all else is window dressing until we hear from the FDA.
Anyone know what BR did this latest quarter with its holdings?
Happy Palm Sunday to everyone.
I have been seeing a lot of talk about “add on” therapy and wondered about this myself.
Perhaps the term “add on” is referring to the fact that regardless of the drug you are currently taking, blarcasamine can be “added on” without terminating your current medication regiment? This would be well aligned with our entire trial criteria for all the trials we have ran across multiile diseases. Just a thought as we lick our wounds and await news of a Fda feedback.
Also, again, while this is a major stumbling block I intend to wait it out through the Fda interactions to see which direction we take. I saw a few references where drugs, upon their submitted date for CNPV were approved within 55 days.
Im not telling anyone what yo do but with the current management, all is not lost. The whole EMA, chmp (they dont deserve uppercase letters anymore) is starting to be reminiscent of the Biogen distraction. Looking back in the future may prove it was just a speed bump to slow us down to market.
One last point, anyone else get a nasty taste about Access Ad? What is this for now with a non approval? Who will have “Access”, wealthy and well connected Europeans while the average Joe just got a death sentence? I dont really know but with our company being the only drug company in the program it appears to me that it also gives everyone a peek at our MOA while we spend 2-3 years on a new trial. Pathetic.
I often remind myself, this time included, that Gods timing is always perfect, even down to the millisecond!
Tred
Dr. Missling definitely built “too small of a boat” to get us across the ocean of approval. I am waiting to sell until I see how the FDA responds to our type “C” meeting.
On that note, with the EMA failure does our NDA package (EMA 90% the same?)have to be redone or can the OLE data and brain preservation data simply be added? If the OLE was not allowed to be submitted or the brain atrophy then it makes sense to add it into the NDA, no?
This is severe disappointment so whatever the board chooses is fine with me. Can or would Dr. Wolfgang Liedke run Anavex?
I have a few years to go until retirement so this will be a small setback but to think of the death sentence that was just signed n sealed for 10’s of millions of people suffering from AD, and all the other CNS disorders that would have been prescribed off label, over a few trial technicalities is morally reprehensible.
OAN I wonder how many funds will be forced into selling and what BR and SS will do?
Tred
Sounds about right hnbdger, thats why Im trying to stay close to neutral with a slight bias towards approval. It doesnt do the board any good to get the pie in the sky pps “cart” out in front of the horse again….for the 100th time.
Let it play out folks otherwise your setting yourselves up for failure, imo.
Great for Blarcasamine but bad for mabs. I wonder if the bad sideaffects of the mabs will be shared alongside of the minimal, if any, positive results?
We know who wins in the end. Let us carry our cross given to us with grace whether its our personal health or that of a loved one until a new SOC is approved. The bar for approval is super low.
Holy Crap, I got through 78% and couldnt take anymore, its been a long day and had to pull down an ice cold ballast point grapefruit sculpin moving now into my second. Its in my top 5 all time favorite beers.
As an investor Im going to have to pull back from daily absorption of message board posts after this latest development. The majority of time I have spent processing this stock has me borderline turning it(and others) into a false idol. Nothing I, or any other here can do is going to be a “sway” in this outcome so I think praying for Gods will (which I need to highly increase) will be my new increased fight. Maybe theres a reason why its not His will for our drug to be available to the masses right now. We always think we know best or our timing is “king” but ultimately, for those that believe, our lifetime is but a blip in the radar screen in the big picture.
Carefully climbing down from my soapbox (again 1.5 grapefruit sculpins in) I expect at the very least to re access any new PRs as they come out and at the very most wish for a very happy birthday gift at the end of April…..all God willing.
Cheers and happy Advent to all!
Tred
How can insiders buy stock ahead of news being released unless this was a planned buy some months ago? Just curious.
“ If we get approved in April and make my birthday the best ever,”
My birthday is also at the end of April, so right there with you.
After re listening to the CC I do not care if we run another trial or not, we have THE best drug in the world that for some reason (greed) cant get approved.
If the EMA snubs us, they all deserve to lose their population to AD and all I can say is FDA here we come! Last I remember submission packet is 80-90% the same, we have much more data to add and theres a new program called CNPV.
“ $20 million increase in cash, so some shares were sold.”
Smart move, cant let the cash get too low. It is 70% of baby Pharma’s demise. Moot point here imo.
Great CC. Helped me define an investment strategy moving forward as the phuckery will surely continue. Upon a formal negative opinion by the EMA I am positive the share price will reach all time lows where I will make a large purchase in preparation for an approval (even if limited) come April. We also should hear about more FDA interactions by then as well for a US NDA.
This is where the real money is made folks. If you believe the science and Warren Buffets strategy then you buy when fear is high (NOW) and sell when confidence is high. This is THE transferring of wealth from the poor to the rich.
Know what you own and appropriate your own risk/reward strategy but my money is under lock and key and Im staying put.
Cheers
Tred
One question, WHY? Why was this data not allowed in one or two of the clockstops to be introduced? “Pulling” us into submission has saved us nothing unless the goal is to allow this data in the next 15 days to be submitted.
This stinks to the high heavens.
So, just a bit of clarification. I am now under the impression that the peer reviewed paper that came out in January was not able to be considered, which validated our MOA, at any later communication with the CHMP with our MAA application, is this correct? If so why did we apply 2 months before? That paper took many many months to be presented.
Ive bought at .20 a share (.80 post split) all the way up to $12 and back down again. I dont swing trade or “wait” to buy because I believe in Dr. Missling, his team, and the science and if one does, you will not even see $12 on a chart once it is approved.
The price is right at my average, Im ok with where I sit ahead of approval. In the event it gets pushed to December, I can surely wait.
Cheers
Sorry, wrong board. I have been here accumulating since .25 a coin, wish I had bought more.
Regardless of the news tomorrow I am not selling any shares. I have not invested for a decade accumulating a position for some short n distort group to shake me out of my shares. The data is there, the unmet need is there, we will get approved and whether the market reacts right away or not is not of consequence. Remember SAVA with complete crap had to announce results a second time, one week apart before the market reacted. In other words they had to sign a secondary for the market “gatekeepers” to feed at the trough.
Gods will.
Regardless of the news tomorrow I am not selling any shares. I have not invested for a decade accumulating a position for some short n distort group to shake me out of my shares. The data is there, the unmet need is there, we will get approved and whether the market reacts right away or not is not of consequence. Remember SAVA with complete crap had to announce results a second time, one week apart before the market reacted. In other words they had to sign a secondary for the market “gatekeepers” to feed at the trough.
Gods will.
The CHMP's outcome is usually made known promptly after the discussion and final vote,
Well said Autophagy. The graph that has been posted here before (decade long) showing institutional increase in share ownership with the pps decline overlayed tells exactly the same story.
Greed gets what is due in the end.
Mathew 6: 24
* “No one can serve two masters.m He will either hate one and love the other, or be devoted to one and despise the other. You cannot serve God and mammon.”
So, the expected binary event for AVXL's share price may be sooner rather than later.
Professional phukery pulling out all the stops as usual. Happens right before and right after every good news clip for the last 10 years.
Revenue and partnership puts a stop to it and not until then imo. Its too easy for the crooks to paint the narrative to the general over all market from a downward price movement for those not familiar to the science.
Yes, ty, 3 digits short.
bust the shorts nuts" Perhaps announce the day after we get an approval!!
On top of waiting for approval any market downturn should not hurt us technically as Dr. Missling has kept a 3-4 yrs of cash runway in the bank. This has been one of the reasons imo that we are not trading in the $4-$5 range like others ahead of approval. We dont need their money to reach approval. If there were a sudden increase of cash reserves it wouldnt necessarily be a negative but rather imo this would be a sign by Dr Missling that we are going it “nearly” alone.
All good!
Is it possible that an MA (of any sort) triggers an agreement that has already been negotiated between Anavex and a BP (Roche, Sanofi, etc.) where they take a significant stake at a high share price valuation or buy out Anavex completely?
Is this why trials are paused - why PD has not started - because the BP wants to manage those trials?