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Re: Genetic Screening for new trials.
Thanks Investor
I’m guessing all this data needs to go through the Ariana sausage machine to find out what exactly those most favorable genetic factors are.
Why hasn’t the PDD or Rett data gone through that process? Or it has and we’re just not privy.
I’m assuming the genetic profile it comes up with would be across any/all indications and not just for Alz.
Shouldn’t we have gotten a picture of the genetically perfect patient already? And shouldn’t it be incorporated into our Fragile X trial?
Thanks
Missling was telling us like we were babies.
Look little Johnny at what we did. You see how good that turned out.
Guess what? Now we did the same exact thing again. But this time in healthier people. What do you think is gonna happen this time Johnny?
Johnny: That we’re gonna win?
You damn right Johnny. We gonna win so much, you might actually get sick of winning.
And we’re just “scratching the surface”
Can I get a new shiny bike then?
You can have a Lambo Johnny
https://www.reuters.com/business/healthcare-pharmaceuticals/roche-says-phase-iii-trial-alzheimers-trial-drug-fails-2022-11-14/
Roche's trial failure "takes out the biggest competitive risk to lecanemab," Baird analyst Brian Skorney said in a note.
Ha!
I guess we’ll have to count how many times Missling says “reverse, halt, etc” on Monday.
Also need to count how many times he busts out in giddy laughter.
His body language and words will be telling for all the tea leaf readers.
Does this conference signal that our data is better than mixed since a mediocre TLR can be received negatively causing a significant drop?
A new corporate slide deck with old data could be misleading especially if the phrases “changing the trajectory of Alzheimer’s” is still in there.
Even the old slides, although true about the data seen during that time can lead to WGT conclusion by new investors.
Can Missling present at Guggenheim and use words like reverse and changing the trajectory of Alzheimer’s if he knows the results are just ok or if it’s a failure?
Can he talk up our previous results and then release something that contradicts our findings, our MOA, years of research?
Can he continue to tout dose dependent improvements and then not deliver the same two weeks later? With a straight face?
His reputation would be crushed. And it would be downright cruel to get new investors to put their hard earned money to work during a recession just to make them lose it.
Ok Misslng, what’s the move here. Tomorrow seems like a good day for TLR.
He has never dropped news on the day of a conference that I can recall. No reason to think he’d do it this time.
A lot of new eyes on the company. Be nice to have something exciting to talk about instead of telling them news is coming in two weeks.
So why don’t you invest and roll the dice on the biggest binary event in our history. Cuz I’m gonna tell you all these great things that’s going to make you think it’s gonna be a huge success. Then I’m gonna drop mediocre news that makes you lose a big chunk of it. Thanks for inviting us. See you next year? Ha
Or. Here is our corporate presentation. Then drop news a few days later. Bam. Smack in the face. What the? Why didn’t you ugh? What?
Thanksgiving week is the week after, so that week is prob out. Unless Missling wants no one to pay attention. Or he can pull another CC on the Wednesday before to make us all panic. Please God no.
Make your move buddy.
Is this our first time presenting at Guggenheim?
Watch out for our results. They’re coming. And they suck. Ha!
That makes no sense to advertise the biggest event in our company’s history if that we’re the case.
They could release the TLR and discuss our MOA, etc.
People are not dumb. If Missling says he cannot expand on our results due to the embargo, no one will be pestering him with questions.
This is not an FDA trial. Just like with the Rett debacle. I believe it was the EU who labeled that trial as a P3 not the FDA.
From what I understand, the Alz trial is a TGA trial done with their regulatory oversight.
We have zero sites in the US.
Anyone?
Wouldn’t the TGA have precedence here?
The gene pathway poster stated, “These findings will facilitate contextualization of upcoming readout of ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical trial”
“Expression levels of dysregulated neurodegenerative genes were restored by the therapeutic effect of ANAVEX®2-73”
That poster was published July 31st.
I’m guessing at that time they likely had an idea if the Alz trial was successful. Or by looking at the mounds of OLE Alz data from our 2B/3.
Everything the the company has ever said and presented has pointed to the same conclusion. Every piece of 3rd party data has confirmed it as well. Hundreds of patients in the OLEs are also likely adding to their confidence.
Hence no change in language. With the exception of a decrease in qualifiers.
Has Missling learned from his mistakes?
Does he care about timing? He never has although we always seem to think he has a master plan on how to burn the shorts. He didn’t care when he decided to have our CC before the long Thanksgiving weekend. Which made everyone think bad news was on the horizon.
Does he use opportunity to boost SP or provide transparency to avoid confusion?
Big time screw up with the Rett AUC debacle. He could have PRd the change to a P3 and he could have said he is changing the endpoint to a more rigorous standard. Both of which would have provided an SP boost.
And what about the share offering that capped our SP. Where the company immediately turned around and sold for a profit.
Did he learn? Is he planning the release more carefully?
Is he Missing opportunity? Exposure? By not releasing TLR sooner? What’s the benefit of holding?
He could be filling the coffers, generating buzz about our science, creating excitement and pressure at the same time. Maybe tomorrow?
I don’t think he cares about losers like AF. He never has and would be dumb to strategize around what he may or may not do.
How about some transparency. To avoid speculation about massaging data or a bias outcome. How about telling your shareholder what the F is going on since it’s been 4 damn months.
You have all these catalysts lined up for quite some time and we have seen very little progress on them. Do we really think he’s gonna check some of those off? The clock is ticking.
You’ve got a conference and a quarterly CC coming up shortly. Please don’t hide behind the embargo policy! Let us know what the freakin plan is.
Did you learn anything about communicating with shareholders??
Let’s get going here!!!
If WGT. Then lay down those cards. Why wait? There’s no benefit.
Unless he has the super duper master plan to burn the shorts and get us new shiny bikes. NOT!!
Thursday Newsday!
Someone had to say it.
Interesting. Any idea how long that was after the trial ended?
I agree with all this but why the guessing/waiting game?
Just tell us we’ve met and the best part is coming at CTAD.
It must be enlightening having the PDD OLE and the Alz 2B/3 data in hand at the same time.
What a treasure trove of information.
Just hope it’s more confirmation instead of questions.
Getting a little frustrated here to say the least.
All a guessing game as to what the hold up is. Right now it seems like we did not fail and we’re just waiting to see our degree of success.
I can’t think of a good reason to hold back TLR. The positives far outweigh.
I think we all know they have the numbers.
Next week will be dominated by the midterms. Our headline won’t get the attention it deserves.
The week after might be too close to our quarterly CC.
Tomorrow is good a day as any!
Let’s FN go!
In all these years, after seeing all of this OLE data in multiple trials with hundreds of patients, Missling has never changed or wavered in emphasizing several phrases including: less dementia, ability to halt and reverse, homeostasis, etc.
You would think these phrases would change if that’s not what he’s seeing. Even in the last PR about CTAD, he left those phrases in there. Boiler plate? Maybe, but I think he’s more particular than that. Even leaving in the economic burden piece to that short PR is purposeful.
I’m feeling a PR this week. A week before that EU conference and a month before CTAD. Would he go to this conference as the “expert” in these types of biomarker driven trials knowing he has failed. Someone posted the topic prior. Probably not.
Would he release TLR after presenting at this trial? That would be messed.
Getting exciting here!
Just throwing it out to fantasy land.
Not sure when the last time there was a breakthrough that was this potentially disruptive to so many.
What if our results really are that great? So great it warrants a super expedited review and approval.
How does Missling navigate? Does he just go through the same ole process? Or does he go to the FDA to give them a heads up.
Look what we have. This may cause some issues with your “friends”. You may want to prepare for some pressure.
Or ask. How do you want us to handle this? Can you give our trial pivotal status before we release?
Not saying it will happen. But these results, if extraordinary can have ripple effects.
Sometimes things require a different course of action. Hope and pray this is the case. Not just for my portfolio but for mankind. We are in desperate need for CNS hope.
So is Missling just holding on to the data for shts and giggles?
So he’s just gonna say Embargo. Embargo all the way to CTAD.
Come on man!!
Agreed. Staying radio silent would send the wrong message.
Hiding behind the embargo policy on the Nov 8th presentation and our Quarterly CC will not be received well. It will look suspect.
I'm sure with that team over there, he can think of something positive to say. Not rocket science.
How about we met our endpoints and are excited? That would be a good start.
If Missling has groundbreaking data that blows away the SOC and Biogen, he should release it. No brainer.
-Ugh. This is the best data the world has ever seen. Maybe we shouldn’t release it. it’s a violation of ctad.
-HAhahahaha. Yea right. You see what we have!!
-But they might not want us there then.
-yea. Ok. Sure. Hhahahahaha
-Maybe we should keep people guessing as to how good it is and surprise everyone in a month and a half.
-yea. Sure. Ok. You’re fired.
-but but but. The embargo… the emb….
When you have never before seen results. You do whatever the F you want.
Hopefully that’s what we’ve got.
He did already throw out the ORAL jab at Biogen in the CTAD PR.
Bullet proof PR could be on the way.
I think before any of the catalysts are met, Missling will give us a PR about our Alz data, especially if its groundbreaking.
He can say a lot without specifics. Just mentioning Reversal is enough, if it did happen.
There's no reason to believe it didn't given all we've seen.
They could have just presented a poster for the sake of science, especially if it was bad.
No need to do an oral presentation about how much you suck.
It’s either going to be a blessing or a curse that our first biggest true test is the most difficult.
It is the test that all our other indications will be judged and assigned promise, probability, value, etc.
We’ve been throwing powerful words around for years: homeostasis, prophylactic, reverse, less dementia, upstream, gene pathways, etc…
Will all these words will be just words or will they carry weight? If our trial isn’t that great, we go back to trying to prove these words have meaning for our “platform”.
All those potential indications floating around the brain will be that much further out of reach in the minds of investors.
Moment of truth is here. Exciting and scary. For me at least.
We need a good PR to get a run. No ambiguity. If it doesn’t clearly say we met endpoints people will think otherwise.
Who will attend the TLD presentation of little unknown Anavex with a novel MOA if no excitement is drummed up?
If our data is great, if you want people to know and get excited, if you want the movers and shakers to pay attention, you let them know something big is gonna happen. What’s the point of keeping it quiet and surprising everyone in a month and a half? No data now will be suspect.
No one here knows exactly what can or cannot be released now or what exceptions can be made to the CTAD embargo policy. All I know is it would be the wrong move not to release a well crafted holy shat PR if you have the goods.
Anything else will be seen as nothing special to see here. Followed by no anticipation, no run up, no excitement for our science, etc. just another ho hum.
What’s it gonna be? Go big or go home.
Good post!
It’d be crazy for Missling to wait until CTAD to give us TLD.
If you have world changing news, you announce it. Still plenty to share at ctad.
Missling needs to do exactly what Biogen did.
PR - Endpoints met and percent decline improved.
Would have rather had a 2fer. TLD now, generate buzz, and additional big splash at CTAD.
Maybe we still can. Just don’t want radio silence and no run up to the event.
Thanks for laying this out so clearly.
It explains a lot especially as to why the PDD P3 trial has taken so long to start, why no peer review or full data presented.
Missling probably had potential partners picked out years ago.
Make a clean deal. No need for chaos or bad actors.
This is in his wheelhouse.
True. So disruptive to so many.
Missling needs muscle. Pfizer??
Yep!
Then our Platform!
Yuuge!
If the words improve or reverse are highlighted in our results, we pop big.
At least 5B increase in MC. Possibly 10
Maybe not immediately but it will get there very shortly afterwards
Forgive me if this was asked before.
On slide 40 of the corporate presentation, why does is say, “Demonstrated improved MMSE and ADCS-ADL through 148 weeks for ALL patients”?
In reference to those 2 graphs that have been discussed multiple times.
Thanks
Nothing wrong with tomorrow Missling.
One week after Biogen.
"What they have in hand is the best currency a biotech on the verge of exploding"
In reference to options, hiring and deal making.
Having cheap shares ready to explode can also make a deal with a potential partner that much sweeter.
And as many have stated, locking up a partner now has numerous benefits.