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Last week for shiny bicycles before Christmas!
It seems that Missling's plan for this year was to stay low key and under the radar with ONE corporate presentation and very few investor presentations. He gives investors just enough information to keep them from pulling out the pitch forks while internally there is so much happening.
In past years, I and many others have thought of fantastical reasons for many of Missling's actions or lack of. All of which don't come to pass and Occam's Razor ends up being the explanation. However, I feel this time is different.
Easy things like the ones mentioned above are purposefully left out. They take little effort to do, but they don't do them.
IMO big things are happening and a new and improved Anavex is about to be unleashed. I don't think it's fantasy land this time although I have frequented that place many times.
Exciting times!
Let's give the Rett community some hope for Christmas. Let's go Grinch Missling!
I take that to mean the 2/3 trial data was strong enough by itself without the need for the OLE data to strengthen their case.
Someday we’ll see the peer review just like someday we’ll see the Rett.
Ok, Just get the damn Rett data out. Then get a fresh corporate to start the new year.
Upcoming and On Track
He understands English enough to know what they mean and how to use them.
Let’s Go!!
Random thoughts.
Is Missling massaging Rett data. I personally don’t think so.
He gave the explanation of an additional safety check for the Rett delay. He didn't say we are analyzing data or trying to contextualize the results. If he did. It would indicate massaging.
Could he be using the real safety excuse in order to hide the fact that they are massaging? Yes and if it turns out that the results are ambiguous and they just happen to use the extra time to make the data look better, everyone would realize he wasn’t being forthright during the CC.
At this point, when possible partnerships are on the horizon, integrity matters.
Rett was supposed to be the low hanging fruit and the recent hiring tells me it was successful. It seems they're ready to move on to other trial initiations. He did say, “we will let you know when the first patient is dosed” when asked about the Parkinson’s trial. I take that to mean, they’re working on it and it’s just about ready to begin.
Also, when asked about the Alz data and what he gave to the EMA. He said, the data with the publish date of.. and then switched to another sentence. Did he just misspeak or was it a mistake that he almost made and caught?
I’m still optimistic about Rett data coming this year. Even with the additional safety step, it still leaves plenty of time. Missling knows shareholders have been asking about it. He has to have at least some pulse on investor sentiment.
When we can afford it, it would do us well to have a COO. This job is getting too big for Missling if the trajectory continues and it seems like it is. At least he gave up the Chairman position, I believe voluntarily. Messed up that the corporate isn’t updated with Ma’s new title.
I also believe as others have said, Missling has been in communication with the FDA. I can’t see him waiting for the 96 week OLE data, when the 48 is sufficiently telling.
Big things ahead. Glad the move down finally stopped. Was starting to shat a little.
Low share price working in our favor to attract talent with options. And incentive to be as successful as possible. Vested interest.
We can't pay you as much, but these options will be worth it. Check out our plan and our data!
Ok. We're in.
Agree. Or at the same time as the FDA. Someone mentioned BTD which seems like a worthwhile effort.
Someone also mentioned 48 weeks of OLE which also makes sense. Why the need for 96 week data at this point?
Mind boggling how Missling can run this company remotely.
Accountability, oversight, hiring, project delegation, etc. …
Difficult to be effective. IMO.
When you’re juggling too many things. Sht gets sloppy
Can we get a freakin updated corporate!!
One for the whole year! That’s crazy.
Anyone have an idea as to how many weeks post trial this additional safety check is scheduled?
Is this common? I've never heard of a follow up safety check.
Any idea how much longer in the OLE?
Could this mean he is not as confident in the trial data as it is? To go for possible AA.
Seems like a long time to wait if you have what is needed now.
TIA
Isn’t it always a webcast and conference call?
I don’t see anything about a video.
Prophetic examples, also called paper examples, are typically used in a patent application to describe reasonably expected future or anticipated results.
Does anyone know how these hypothetical examples are made up?
I'm sure they are evidence based to some extent. Just don't know how much. I don't think Missling is sitting around saying, ugghh this sounds good. Yeah, let's put that in.
TIA
and not only that.....
So many exciting events and possibilities on the horizon. These next few weeks can solidify our place as a “real” CNS/ rare disease player and innovator.
Rett - Gotta be strong as hell with no holes.
Let’s FN go! No massaging. No games. Just kill it.
Bring on the partnerships!!
Hope TGA is the next shoe to drop. Quickest path?
I don’t know why but not having a new corporate presentation bothers the crap out of me.
Why not have one of the 40 employees update it. So many things to put on there and showcase. New hires - 2 Chairmen, Rett initiative to revise and improve measures, new biomarker data, financials, etc.
That doesn’t take much effort and keeps investors informed. Do they not care enough? I pray that they are just preoccupied with more important things, which I believe they are. But still a new corporate is not much and would help shed some light. We are working. We are moving forward.
I know they are and I don’t need hand holding, but nothing is FN messed up. I believe when they do decide to have a new coming out party, it’s going to be a different company emerging. One with revenue in sight and a solid plan communicated clearly on how they are moving forward.
With all this time, hopefully it’s a detailed TLD with some other measures - seizures, quality of life, etc. It seems like they’re waiting for something, quiet period or not, something is about to happen.
Frustration and excitement! We are about to hit our stride. IMO
It's a good dream and one that I have too. I think it's more realistic than some think. It's eerily quiet and uncharacteristic of this company's behavior. No movement, presentations, corporate update and yet Sabbagh comes on board. Not a nobody. And probably not someone that wants to sit on the board of an idle company.
Things are happening and I think it's better than we think. That Alz article from Seeking Alpha really helped to lay out the case for approval. The FDA wants to move science forward. I don't think it will stand in the way of what seems like a no brainer AA.
I actually believe they have been in negotiations for quite some time. Just a feeling for whatever that's worth. What BP doesn't want to deal. This is too big for us and it's the right move at this time.
Let's see. Anavex is just starting to enter its growth phase. Those getting is now are darn lucky. We've lived through watching them learn to walk. They are about to run.
Exactly why they need a partner. They are ambitious in their speech and presentations but just don’t have the resources or man power to move those agenda items forward.
Good intentions but that’s all they are at this point. Hoping it will change soon.
Maybe tomorrow.
If not partner, go on a hiring spree with the expected revenue and hit the gas.
In all seriousness, I do believe something is in the works.
However, I also believe we go down pretty hard if Missling doesn't deliver before the cc. His credibility is shot already and no one takes his word seriously, especially in regard timelines.
He has been bolder in his speech, talking about AA and partnerships but the delays just make him look more foolish and less credible.
Hopefully he restores confidence.
I personally am hoping for a BP partner. It will help with oversight and accountability in addition to support in trials, funding, infrastructure, etc.
Lay those cards down and show us your hand!
All 40 employees sitting around all day playing online poker.
Missling - Ughh what should new do now? Wonder when the paper is gonna come and when the fda is gonna give us that meeting?
Should we call Kun to see if he finished crunching the Rett numbers?
Nah. Don’t bother him. He was in the middle of a hold ‘em tournament.
You think the shareholders will be mad when we say the same thing at our next CC?
How much madder could the get?
Uncontrollable laughter. Hey Clint. Don’t tell them we’re tapping the Lincoln Atm to fund our addiction.
Missling. You think we should invest in some casino stocks??
U controllable laughter resumes.
I don’t see the full Alz data or peer review as being a catalyst since it will reveal the information Missling purposely held back.
And logic dictates that he held those numbers because they were not that great despite the other data we did get.
The chorus of I told you so’s, will overwhelm the positive data that is there. If there is any press at all, it will balance the negatives with the positives and we all will have a lengthy debate about whether or not approval is possible.
The only way I see it as being a catalyst is if Missling tells us what the next steps are according to the FDA prior to its release. Otherwise it’s a neutral event.
Coming out party! Let’s go
Data releases
New corporate presentation showing off the goods and potential.
Please God before Turkey day. I don’t want spam and yodels.
I hope they smartened up and decided to apply everywhere instead of pigeonholing themselves to the FDA.
We don’t need AD to happen. We just need the FDA to say it Can happen.
File for some type of approval
Good post. Trial results on their own is not enough. They need to educate the FDA on our MoA and clearly explain and demonstrate how and why it works.
So, 2 full weeks before Thanksgiving week. Last year our CC was the day before Thanksgiving I believe, which threw me for a loop.
I know the data is ready when it’s ready, but it’d be pretty embarrassing to go into the cc with the same exact statements as last time. Data is coming and we will meet with regulators.
I’m guessing we get TLD for Rett, God willing before that. Or we’re eating Spam for Turkey day. Ha
I just hope they can provide next steps. It's seems like groundhog day around here every time we hear, "We will meet with the FDA....
How about, "We met with the FDA and they said this..." Please no more, we are still analyzing the data! They have all they need. They have said so. The street needs some concrete action.
We will see with the Rett PR if the Anavex culture has changed. As of now, no one believes Missling's words and in turn the science loses credibility in investors' eyes. I know that matters little in the end, but showing that your words matter and that you can deliver means a lot. To us, to future partners, to regulators.
Let’s get that data out. Less than 100 patients. Questionnaires not rocket science.
My 10th grade daughter can crunch those numbers in a few hours.
We have a game changing breakthrough science with a first timer CEO. That is the crux of the problem.
-First time leading a company
-First time doing trials
-First time trying to commercialize
-First time dealing with regulators
-First time dealing directly with shareholders
-etc. etc. etc.
Our science is too big for him. Experience in these areas matter.
Small mistakes because on inexperience matter at this level.
Who has Misslings ear in these matters? Yes, he has a board and a team with some expertise but not the seasoned battle tested expertise at a level we need to move forward.
Sometimes the job is just too big.
Thanks.
I’m having a hard time understanding why our Alz data doesn’t virtually guarantee us getting AA.
We met the definition of a successful trial with the one primary and our secondary. We have the gold standard biomarker that the Mabs were approved with.
We have the reduction in brain atrophy and safety to boot. On what grounds could the FDA deny us?
Small trial? I thought these results were harder to get with a small trial thus our signal is stronger.
All said before but the decision seems straightforward. Even without the ADL data since elements of ADL are seen within the CDR. Not sure what there is not to like.
All I see is winning!
I hope so. The bottom line is either we’re better than Trofinetide or we’re not.
TLD will hopefully put that question to rest. We’ve been calling their drug inferior all this time and need to show that definitively.
It’d be a bonus if we could see some symptomatic benefits that could translate easily to Fragile X and others showing the breadth of treatment.
That’s if it happens and if it’s timely. Missling has good intentions and likes to take his time to get things right. The problem is he takes his time and gets things wrong.
He can restore his credibility with these major accomplishments. I pray Missling learned some hard lessons about being a leader and we don’t end up in the same cycle of never ending questions.
What do 40 employees do all day for 40 hours a week?
Dream fantasy scenario - Missling decided to apply to the TGA and EMA for Alz cuz he realized it is dumb not to. He did this months ago and a decision will come out shortly.
Surprise!
Any predictions on when the upcoming publication could be? I hope all that is required is to slip in a section or two about the new MRI and Amyloid data.
Of course, the longer it takes the worse it starts to look.
Right. What was the point of even doing the trial? To get the genome data or the tiny OLE leftovers?
Missling is not a finisher. He’s the guy who has a whole bunch of good incomplete projects lying around the house.
Hope Kun can bring Rett to the goal.