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Are we going head to head with this?
Two more weeks left for Missling to PR/Submit for CTAD.
If he doesn’t, it will send a BIG message and it’s NOT a good one.
These next few months can pretty much take us from promising biotech to dominating BP.
If the Alz results are blockbuster, I may have to show up to the next ASM with 100 new shiny bikes parked outside to give away as gifts for the attendees.
What is Missling doing right now? Rejoicing over the unbelievable data or sitting in unbelief that the results are not as good as hoped for?
Either way he has no choice but to present at CTAD. No more hiding. Our platform is on the line for the world to see. If something good can be taken from it, it needs to be presented.
If the results are irrefutable, I wonder if releasing TLD first and then presenting further data at CTAD would be the right move. If it’s that good, I would think he and the team would want to get it out asap.
Could also follow with the PDD OLE at the CTAD as well and call it the Anavex show. Either way, Missling knows he needs to get an opportune time to raise money. Even more so if the trial doesn’t meet his expectations. He is in the perfect position to create some buzz if he wanted to.
Exciting times coming up. The moment moments we’ve been waiting for. 3 big trial results. All of which have shown prior success, now given an even better chance to show greater success with longer duration, stronger patients, higher dosage, etc. All the cards being laid down in a matter of months.
Big things happening! I’m ready to win so much that I’ll actually be sick of winning!
While all the little boys and girls were playing outside, lil ole Chris Missling was inside playing with his delux chemistry set.
Always dreaming of changing the world. In class, he would often doodle these random letters. Other children thought it was weird but he knew exactly what those letters meant.
It meant his dream. It meant his destiny. It was
C T A D
This is the moment. His moment. And at this pivotal moment in history he will reveal the other word he’s been doodling at his desk.
K R A K E N
Nice. Missling said he was working to get a global reach.
Lonza - We provide a wide range of services and products from early phase discovery to custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. Our scale and resources mean we can provide a one-stop solution for our customers to help people get well, feel well, and stay well. In 2020, we supported more than 820 preclinical and clinical small and large molecules, more than 245 commercial small and large molecules and produced 230 billion capsules.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately more than 17,000 employees,
My apologies if this was asked before.
Does the PDD OLE go through the same data lock process as the Alz?
Thought they had quicker access to the data since it is an OLE. Why the wait to release topline?
Thanks for the detailed post!
Thanks. Will it be posted in their site?
I’m hoping for a meme type speculation playing run before results.
If the good doctor gives a hint as to when data will be released we just might see it.
A oral presentation announcement at ctad would do it.
A planned CC on World Alz day would be an unlikely dream.
Just need a little telegraph.
Thanks. Any idea if the 30mg dose can achieve a high mean concentration?
Groups 1-3 all performed better than the SOC but did much better especially during the first year. I guess it’s good that our trial is only 48 weeks.
Do we know which dose group 1 had? I know we can assume that higher dose means higher mean, but I’m also assuming that’s not always the case.
Can we get at least one catalyst checked off while waiting for TLD?
How bout a trial start? Any trial. Let’s FN go!
He may want to see the Excellence results before starting Fragile X. That seems to be his MO. So mid 2023 for that?
I guess you keep on changing the dates for the catalysts they are bound to be true one year. Ughh!!!
Unfortunately the ambiguity of our trial status is a reason that’s preventing us from an SP run.
Is it pivotal or not, need another, 2B/3 confusion - what does that even mean, etc.
The street so far doesn’t think the read out is a big deal.
Only a big step of many. I guess we’ll see if Missling can work some magic.
Any thoughts on why we’re not running now?
Summer doldrums
Still risk off
No rush since he said fall
No confidence in Missling after Rett debacle
I still think we’ll run as we get closer. You?
Big implications if successful. Speculators alone for an Alz event should make it go.
Should
Doesn’t that bode well for our Alz trial since one of our endpoints is a reduction in cognitive decline compared to placebo?
The aduhelm disaster works in our favor. It shows how desperate the FDA is for something/anything that shows a glimmer of hope.
Add on the amyloid fiasco, and we have an agency that is wants a narrative change. Perfect pivot opportunity.
Embrace change, hope, new MOA, precision medicine, safety, economic benefit etc. lots of good buzz words to make them look good. A shame that politics and perception works that way but this time it’s in our favor.
If a good amount of patients improve, stabilize, etc. How bad would they look to say we need more data? I guess loads of crappy intravenous exploding head data is better than a smaller amount of positive safe data? Not sure it makes sense but then again so many things that happen in government don’t.
Desperate times calls for change.
FDA, Biden, CNS sufferers need hope and change and more importantly a win. It’s innovation. It looks good. It’s safe. Seems like precedent got thrown out with aduhelm, vaccine, etc.
Oh wait only some people improved and stabilized and it’s completely safe. Hold on we need to wait. Keep them on that other crap that barely works at all. Funny world we live in.
Let’s see what happens
I agree. They have done their homework. Also if we end up better than the SOC and the fact that some countries have stopped covering it, I would think maybe in this case there’s a possibility of them acting first.
I would think just being better than the SOC would get us a decent SP bump.
I’d gladly take that. What odds are you giving that it will be better than the soc?
Please enlighten us on what “be an investor” means.
According to you it means.
-Don’t ask questions, speculate or discuss to learn more
-Don’t use charts that have been relied on for decades for good reason
-Don’t trade opportunistically while waiting for catalysts
-Don’t read to discover, interpret or challenge status quo
-Do tell people to be an investor when you’ve never defined what it means to you
-Do belittle people whenever you get the chance because it makes you look smart or feel good
Sorry. Couldn’t help myself. We’re all investors.
You must a be filthy rich Investor.
Great post.
I for one don’t care if we need a second trial as long as we’re waiting at $50+
After all we’ve seen, I give it an almost zero chance of absolute failure, meaning hardly a signal at all. That would pretty much kibosh our science and contradict all the 3rd party evidence thus far. And it’s a lot of evidence. That would send us to low single digits.
A strong signal even if endpoints are not met still wouldn’t be a failure. It just means we have to be more precise in our patient selection and it seems we have done the leg work to do just that. In this case, I still see our SP reacting somewhat positively.
World Alz day would be a great time to announce TLD and maybe a deeper dive at the ctad. PDD OLE could also be here as well since he intimated that it would be after the Alz.
Missling said he didn’t want to give off the perception that we’re not focused by announcing new trials/new indication. If he waited until the CTAD beginning of Dec to give TLD, that would leave very little time to meet other promised catalysts. So my hunch is sooner rather than later for Alz
I’m wondering if the companion diagnostic Missling spoke about on the CC is an added layer of sway that could entice regulators to view our data more favorably if need be.
If the wild type happens to perform better, could our diagnostic help pave the way for a P4?
The move towards a more precision medicine approach with this tool.
Thanks. I was hoping to get a further breakdown of how many in each cohort responded. For that mid dose group to remain stable as the chart depicts, you have some that declined, some that improved and some that remained stable. Likewise for the high dose group. A small amount of very strong responders can cause a big change to that group.
Hopefully the peer review of the trial gives us those details if there is one in the works.
Did Anavex ever provide a breakdown of how the high dose patients did vs the mid dose patients in the PDD trial?
I don’t believe they ever broke down the percentage of responders in each group either.
Wonder why that hasn’t been revealed.
Hello peer review??
Missling said fall. There’s no rush to get in now. People a lot smarter than I know how long it takes to get TLD for a trial this size.
It only takes a few days of running to double or triple or SP. We will see the volume increase as we get closer. Then we will know the time is near.
Hard for speculators to stay away from an event like this.
Fall is Coming!
“People came into the trial with dementia and left with less dementia.”
A Missling Fav
My dog had diarrhea for the past 3 days. Been shatting all over the house. No one likes diarrhea.
Trofinetide go bye bye
Not really concerned about a leak. Older folks tend to be rule followers and are aware of the consequences. Plus they are not usually tech savvy.
Family and friends would not want to jeopardize their progress by blabbing since it’s relatively easy to find out the culprit.
It’s always been missing. It’s called Missling’s personality flaw as the number one face and promoter of our science/company.
Zero excitement and energy. Couple of crappy tweets is just not gonna cut it. Years of waiting for trial starts and slow recruitment.
Shareholders don’t have much confidence in him. It could all change in a moment and all would be forgiven. But it’s hard to watch. Especially when amyloid just died and we have the first pivotal promising non amyloid focused trial reading out and no one give a sht.
Get the pump machine going. Put us on the map. You want the science out there. Put it out there and make people pay attention.
Misslings integrity only goes so far.
I wonder why Missling hasn’t hedged his position or cashed out enough to help him live in the event of a massive failure.
His salary isn’t that high yet he has sold very little. Just that one time to prob buy a home.
He has the most to lose here and is not prepping for a worst case scenario.
Either dumb or overly confident. Maybe both.
Like many here.
100% loss?
Yeah. If Alz completely bombs, along with PDD and Rett and no trials start and we find out sigma 1 is a fantasy and all our IP is written on toilet paper.
If Alz fails miserably with zero promise, then I could see valuation cut in half. We have never had any Alz potential in our valuation anyway.
100% loss is 100% out of the question.
Trying to figure out a game plan here. Was hoping to derisk a little before TLD. We’ll see if the opportunity arises.
Let’s say we run to $20 before results. (Being conservative) How much could we fall if:
Complete failure: $8
Promising but missing slightly: $11
Thoughts?
Like many here I’m overweight. Just trying to figure worse case scenario if we get surprise timing of results.
That headline alone could garner us some much needed attention.
We just need someone to write it. Ha!
Are we the First non-amyloid targeting pivotal Alz trial to read out?
Thank you. Seems like we are on the right path.
Thanks.
Can you share your thoughts on how they would do this?
Do they need to first develop a diagnostic that tells whether and how much a patient’s gene pathway is activated by 2-73?
Would this be practical in terms of feasibility and time? Seems like it would take forever to recruit.
Itd be great to do it. Just trying to understand how it could work.
https://www.investors.com/ibd-data-stories/anavex-life-sciences-crp-shows-market-leadership-with-jump-to-85-rs-rating/
Not a big deal. Just interesting they even showed up here.
“Decades of market research shows that the best-performing stocks typically have an RS Rating of at least 80 in the early stages of their moves.”
Let’s see.
From what I’ve read, I don’t see any restrictions as to the amount of data that can be collected regarding time intervals.
I’m sure Anavex has their own protocols whether it be every 3 months, 6 months, etc. I’m assuming it would be at greater intervals considering the length of the actual trial.
I know this has been discussed many times here but I don’t recall ever hearing a clear answer.
Do you have an opinion as to how much of the Rett OLE data Anavex privy to?
I’m asking because of Missling’s statements about having enough manufactured drug for the Rett roll out and the activity in partnership discussions.
Seems like a lot of premature prep unless he has seen Rett OLE data from the Excellence trial which patients have been on for quite some time.
TIA
Why does Missling not care about raising the SP short term?
The Alz and PDD OLE completion could have been two PRs with a chance to reiterate timelines and confidence.
Is he just that confident? Oversight? Doesn’t think it matters?
Why the heck not? Does shareholder perception of a CEO that cares about the SP not matter?
Yet he’ll PR the BTIG conference that no one can access.
I pray we can present something at the CTAD. That may give us the pre run up we all hope for.
Gotta make people pay attention!
I wonder why they didn’t include the new gene cluster data in the slide deck.