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.
Be nice to get two catalysts PRd before the R and D day to get some analyst attention.
Missling didn’t pick that date out of the blue. Alz is a definite, a fragile x start would be a really nice cherry.
Looking forward to a sustained increase in SP.
Just Missling
The ASM was so disappointing. No encouraging words. No, we’re excited. Just a crappy as video with disorganized q and a.
No, new bikes coming soon.
I didn’t get it at all. Unprepared.
Here’s a video. Ok I guess that’s all the questions. Bye. Funny but not funny
Yes, we need the baloney and more of it.
I’m sure they all have an Alz model to follow when giving targets for a “potentially” pivotal P3. The targets should be high given our small float.
Kind of odd that they upgraded before the conference.
At least we know there is news coming in the near future.
We also now know the worth of the word "potentially" in potentially pivotal. It means he has no clue.
I guess we'll see what the R and D day brings. I kind of wish I could see that video again that he played today.
It think it was a failed attempt to drum up some excitement.
Terrible. He didn’t sound excited at all. Played a crappy video that couldn’t be digested.
I guess same ole for Wainwright
How bout a little morning PR. Otherwise what’s new to talk about during the ASM and wainwright.
Same slide deck with a different date?
That may actually give us the fomo we need. Coverage initiation after initiation after initiation.
They all have their models and their targets will def be higher than what’s out there now.
You cannot not cover a potentially pivotal Alz p3.
True, hopefully we get the PR.
I'd say after we complete the Alz trial, firms will have no choice but to cover us.
Imagine our Alz trial being a huge success and reputable firms had no coverage. They would have egg on their faces. What kind of firm are you? No coverage for a groundbreaking company? Your R and D team must suck.
Great post. Wondering how you get approved for something like that.
It’s a great endgame. I’d imagine we would have to get approved for several neurodevelopmental diseases before that’s considered.
Any chance we get some news before then?
There’s no reason why this couldn’t be in person. He knows he would have had to answer some tough questions.
Good points!
Do you just use a country’s resources and government then leave to go somewhere else?
That wouldn’t be right. Thanks guys. I’m gonna let someone else benefit from the work you did and helped us out with. Oh yeah. Thanks for letting your people be Guinea pigs.
See ya!!
Our PDD trial was mostly in Spain. Why is the AEMPS never mentioned?
You’d think they would be our first attempt, application, meeting, etc.
Hopefully by then he will have had the FDA meetings already.
That will provide much needed clarity.
June 21st is perfect timing for an R&D day. The completion of our Alz trial along with PDD OLE data release should attract some reputable analysts.
Hopefully we get some new coverage out of it. I believe many firms are ready to cover, but not exactly sure what the hold up is. After these two items, the y may have no choice. And when it rains, it pours.
Leerink, Needham, Morgan Stanley could be the first to start they wave. The day needs to be more than an overview of our pipeline. The Sigmaceptor MOA needs to be front and center displaying the power in our platform.
Could be the kick we need to get some fomo going after all.
Is the general process patented or just the process as it relates to 2-73?
Not sure if the general process can be patented. Thanks
I hate the fact that our first huge chance to really prove ourselves and our science is the biggest, most challenging cns disease in history.
Should have had the “low hanging fruit” in the bag already.
Pretty much says, we think we can treat any genetic neurodevelopmental disorder. We are not disease specific and can work for all of these and for any of these symptoms.
Pretty bold! Just prescribe it and watch them improve! Ha
That is a great wide ranging patent. Gives us hints to what they are seeing and shows us how fast 2-73 works.
If you have one of these symptoms, give them some 2-73 for a week, see what happens and increase dosage as needed. Nice!!
A method for treating a genetic neurodevelopmental disorder in a subject in need thereof, the method comprising: (a) evaluating the subject for the occurrence and/or severity of one or more genetic neurodevelopmental disorder symptoms selected from the group consisting of: cognitive impairment, motor learning impairment, balance impairment, muscular strength impairment, seizures, sleep dysfunction, breathing impairment, and anxiety; (b) daily administering to the subject a dosage formulation comprising a therapeutically effective amount of ANAVEX2-73 for a period of at least about 1 week, wherein the dosage formulation is selected from a liquid oral dosage formulation, a topical formulation, a transmucosal formulation, a transdermal formulation, a buccal formulation, a sublingual formulation, and a parental formulation; (c) re-evaluating the subject for the occurrence and/or severity of the symptoms evaluated in (a), and evaluating the subject for the occurrence of adverse events; and (d) optionally modifying the dosage of ANAVEX2-73 administered to the subject based on the evaluations in (c), wherein absence of improvement in at least one symptom indicates optionally increasing the dosage of ANAVEX2-73, and occurrence of an adverse event indicates decreasing the dosage of ANAVEX2-73.
Even the analyst questioned their ability to meet all those goals.
He was kind of like whoa. That’s a lot. Which ones are your priority?
Good that Alz as Missling said is on cruise control. He better make sure the CRO knows to make it timely.
Does anyone have any thoughts as to why it’s taking so long to get the fragile x started? Are they waiting for the Excellence data first? If so then, the fragile x will sadly be a 2023 event.
Seems to be a multifaceted meeting - Rett and PDD - Perhaps more
Not sure how that works or is even allowed.
Sure wish we had a buffer before the Alz.
What does it say about our drug when Missling tells us we have choices for our undisclosed indication? Good problem to have.
No wonder why he doesn’t want to partner, license, etc. Good to be greedy but also good to have a smaller piece of a much bigger pie, especially when it gives much needed help to the suffering.
Does Missling have too much on his plate? I’d say yes. He needed help a long time ago and his need to micromanage caused our delays.
Was hoping to unload some into the Alz results. There’s still a possibility. I sure as heck didn’t think our rise was dependent on the xbi.
Ironic how Alz is next up when Rett was supposed to be the low hanging fruit.
Zero mention of PDD P3 trial and expected OLE data is still confusing to me when that’s our biggest completed trial with the best data.
Although the blank check preferreds offer protection, its implementation will be difficult to figure out. Could get messy.
Our company would immediately renew any suffering pipeline.
Will we get a PR on the OLE completion or a PR indicating another extension?
Hello peer review?? Bueller??
At least we finally heard about the undisclosed indication. Good to hear they have choices and are showing preclinical effect many rare diseases.
Hope R and D day brings some fire.
I hope they can attract some high level analysts, journalists, etc.
Seems like an event that could be well received if done right.
If they’re putting our science and MOA on display, people need to see it. Otherwise, there will be little effect.
Does anyone know of another biotech that has done an R & D investor day?
Just trying to get a feel for what it entails and if it bore any fruit.
Wonder what the R&D Day is about? Kind of like an investor day like Apple does?
Why no mention of PDD phase 3 just the Parkison's P3. They are 2 separate trials. Don't think they were both rolled into one statement otherwise he would have made it plural - P3s
Not much excitement in this PR. and No usual - I hope you are as excited as we are.
Hopefully more details in the CC.
Why not mention - we are looking forward to wrapping up our Alz trial and our PDD OLE - Seems like a good place to get the Alz buzz going - missed opportunity?
Maybe Duncan will ask - Why keep teasing us about the undisclosed trial - just say nothing - What a weird statement - We've got something planned, but will not tell you what it is, but will keep on telling you that we have something planned.
Doesn't every company have something planned?
Is is too much to ask for some upbeat, positive, forward looking statements with some detail?
Come on man!!! Let’s FN GO!!!!
Ya never know.
Just for fun, what are the odds that we beat the current SOC? Your thoughts in %.
Mine is at 90%
I can't wait until our Alz results.
I can just picture all these BPs and their CEOs stunned in silence with their mouths on the floor. Then they proceed with a gigantic bonfire outside burning all of their amyloid research along with whatever Alz treatment they were working on. Then all you hear is, "We're screwed!"
Then Adam F goes to finish his hit piece that has been waiting to be published. He goes to add his last words and then throws it in the trash. He pulls out his other article titled, "The Day Amyloid Died". But before doing that he tells everyone he knows to buy as many shares as possible.
Missling's phone is ringing off the hook, but he's just sitting is his chair smoking a cigar and written behind him on the wall is:
"When you look back to see what we did and why, you will understand."
Be nice to hear
The clinical trial report has been submitted and we are awaiting meetings with the FDA, TGA, etc.
The PDD OLE trial is wrapping up and we will move full steam ahead with our P3 trials
Fragile X is set to launch in several weeks and our undisclosed indication is .....
And of course the usual “We are very excited”.
Any chance? Not holding my breath.
Wondering what kind of reaction we get from the Alz completion PR. I’m guessing not much.
I can just imagine the scenario where we come out with stellar Alz results and Adam F rains on our parade with all the usual arguments.
That would be sad and very likely. Then we would repeat the waiting pattern again. I pray that doesn’t happen.
Sometimes letting the data speak doesn’t work so well in the short term.
What is your opinion?
Can the OLE pave the way for some type of accelerated approval?
Any thoughts besides incompetence as to what the hold up is? I know you mentioned the gut data before.
After these results, what is rationale for waiting?
The only think I can think of is he received guidance. Wait on the OLE results and this is results continue as expected then .......
Otherwise he has sat on extraordinary data twiddling his thumbs for absolutely no reason.
Trial infrastructure could have been completely set up by now ready to go on day 1. We don't see and didn't hear anything about that.
This is the most important question. What is happening? We are planning a phase 3 trial answer just doesn't seem like an answer given the amount of time that has passed with NO visible action.
Otherwise he would have nothing under highlights for the quarter.
Maybe he could just place a picture of an egg in that space.
True. What’s wrong with being realistic and honest.
He knows he’s lying when he says it.
This soon to be market bounce will help lift the Anavex boat going into news related momentum.
Need some good progress question at the earnings CC.
Really a shame that we are not having an in person ASM. Missling is extremely generous and forthright with answering questions.
I fired off about 50 questions at the ASM I attended years ago. That was when the “Tip of the Iceberg and You’ll know why” comments were made.
Nice that we’re seeing them get played out. Hopefully when we see the Alz results, we can say, “Oh, that’s why!”
The more I think about all of our discussions these past years the more I understand why Missling isn’t moving as fast as we all want, though it is still incredibly frustrating.
There really isn’t a playbook for what he is trying to do. When was the last time a drug has had the potential to be this disruptive to so many organizations, companies, etc.? Everything we have been discussing, I’m sure Missling has had these very same thoughts and discussions many times over.
When you see the magnitude of our science unfolding you need to move carefully. Answering to shareholders’ impatience is probably not a priority right now. So he’s trying to balance this potential major disruption while trying to keep ownership.
What we have seen so far is pretty hard to believe. Safety and efficacy in so many indications while have peripheral benefits. Unheard of. I’m still waiting for something to go wrong because it seems impossible for this to be so right.
The convergence of all these events of the horizon makes this an intense situation on many fronts and the roll out of the data is of the utmost importance.
Although Alz has been the unconquerable monster, I like our chances given the evidence this far. Glad to be in on the ground floor here and am trying to be patient although very difficult at times. Don’t get me wrong I will still have some ranting posts, but am very excited and positive on what’s coming in the next several months.
Be nice to get a shockingly good eye opening PDD OLE data read right before or after the Alz completion PR.
No deep dive needed. Just give us the topline which takes very little time to crunch.
No need to wait for a science conference. Let’s FN go!!