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Maybe we can get our FOMO run when our MAA is accepted. We never got ours and my mom says it's not fair!
I wonder if Missling will PR the MAA filing or just the acceptance of it.
I’m hoping he does both of course.
It’s strange that Missling had overwhelming support indicated by the votes during the last ASM.
30 million For
3.6 million Withheld
I thought shareholders would have sent a message expressing their dissatisfaction. I know I did.
We are valued at Missling not being able to accomplish a darn thing. So I guess it can only get better. And with the fed cutting rates. Hopefully the tide will lift this boat a little with it
Missling can be a hero. Jury is out. We'll know soon. He made a lot of big promises this year.
Did he learn his lesson?
It seems like pretty clear choice for the EMA.
Would you rather have nothing?
What we have is just as good as those just approved. Better in many regards.
I can't picture them saying.
-Ughh. We'll wait for something more promising to come along cuz we can't subject these dying Alz patients to some dizziness.
-Well, that reduction is brain atrophy is good. But we think it’s not good enough. Ha
-You know. I think we’d rather spend more money and drain our healthcare system rather than give your safe drug a chance. Cuz you know. Something better could be right around the corner that doesn’t cause dizziness and we really need to see a trial where less people dropped out. And Covid and the whole world shutting down with the most fragile dying left and right is a shitty excuse for drop outs. The risk of falling is just too much for our citizens right now.
-Why don’t you do another trial and come back to us in a few years. And make it bigger and longer and maybe have some more try to get better ADL numbers even though these patients are mild.
-In the meantime we’ll work on building our infrastructure to accommodate the mabs.
Don’t you think Missling and team would have discussed these short comings before dedicating more than a year on this filing?
It seems with Kun with his experience would have/should have pointed these out, especially if it didn’t pass muster.
When meeting with the EMA, I’d imagine they brought up these possible obstacles to them and were fully transparent with the data. I find it hard to believe that Missling and the team would proceed in hopes that they would maybe accept it/overlook it by accident, etc.
Thoughts?
How do we know we are utilizing the Prime Scheme?
Fitting vs actually participating. Transparency anyone?
I’m starting to get dejavu here with all these promises happening in such a short period of time.
I remember one analyst questioning Misslings ambitious timeline years ago and of course much of it didn’t happen.
Hope it’s not a repeat. I thought he was done over promising.
Looking forward to Tueday’s CC. Maybe our new/old analyst will show up along with Berenberg who I believe did make an appearance once.
Let’s see if they have any pointed questions about the data like we have here. Should get some nuggets on other fronts as well.
With so much in the pipeline. Just freakin partner and get some damn muscle behind our drugs and get them trials done right and in a timely fashion.
Selfish denying people treatment when they could get it so much sooner.
Did Biogen, etc. include non-completers in their analysis?
TIA
How much meat is left on the bone for the peer review?
So if it’s new data on Sunday the 28th, should we expect a PR on that day?
Not sure if I’ve ever seen a PR on a Sunday. Anyone?
Wondering if Missling will put Rett aside for a while and run with Fragile x with lessons learned.
Much bigger population that can open up to many more indications.
Faster recruiting, larger network of nonprofits, same trial length.
So when do you think we would hear news on the EMA front/process?
It seems filing an MAA would meet the standards for being material.
Right I guess there’s no other choice.
The science will come to light sooner or later and if the EMA decides not to approve, it will just delay it. By a very long time I’m afraid.
Every time we think it’s a slam dunk, it turns out not to be. If the EMA say no, then I guess we are back to square 1 with Alz starting a new longer trial with more patients. No doubt, Europe has a lot to gain and our safety record helps but anything can happen.
I’m sure Missling and the team have weighed the “what if” outcome and felt that it was better to give it a shot even though it could waste years. Oh yeah and tons of money. I’m sure thoughts from KOLs and the “pulling” from the EMA swayed their decision.
Even still I sit here with some doubts. I’m tempted to take some profits after the filing acceptance knowing there will be a pop and a long wait for the decision. Not sure what to do yet. I’m sure others like me that didn’t sell the irrational spike years ago have an itchy sell finger. Tough one. Don’t want to miss the forest though.
For sure we have kicked the sigma 1 door open wider. I just hope we’re the ones to benefit from the scientific progress.
Looking forward to some PRs this week to sustain the momentum, even if it’s just the small cap tide lifting the boats.
Seems like a missed opportunity even just to PR our attendance. Hopefully that’s coming.
-Presentations with some new info on several fronts
-MAA filing and peer review
-OLE data
-While waiting for EMA decision. Start with FDA meetings about NDA
-Schizophrenia results coming after
Seems like we could have a good run coming.
Just don’t Fuk it up!
Almost seems like a pitch for M and A
Does Anavex know if and when the peer review is coming out?
If not - Rehash what is already known and sprinkling some extra details that don’t violate peer review data embargo.
If it comes out before. Great - Lots to present
Without knowing, it seems Marwan would need to have two different presentations ready.
Hope we can generate some excitement.
A PR or 3 would be nice next week.
The site is poorly done and rarely updated. Strange they were snubbed on the slide deck.
Are Kaufman and Hammond no longer on the team?
Is this new structure more typical for biotechs?
VPs and SVPs now. No more CSO, CMO
Chats Answer
Open Label Extension (OLE) trials involve continued treatment with an investigational drug after the conclusion of the initial clinical trial, allowing all participants to receive the active treatment without a placebo group. Data collection in OLE trials can be managed by both CROs and individual care providers:
1. **CROs**: They often manage OLE trials, particularly for larger-scale studies or those sponsored by pharmaceutical companies. CROs handle the logistical aspects of the trial, including data collection, monitoring, and analysis, ensuring consistency and regulatory compliance.
2. **Individual Care Providers**: In smaller or more localized OLE trials, individual care providers may collect data directly. This approach allows for detailed, real-world data collection and may be more feasible for smaller studies or those conducted in specific clinical settings.
The choice of who gathers the data in an OLE trial depends on factors such as the trial's scale, the sponsor's resources, and the study's design and objectives.
Missling said they haven’t seen any of the OLE data yet. Probably a white lie.
Hopefully Missling keeps better tabs on the CROs this time around. Although we don’t know for sure that was the issue last time, it seemed like it was in part.
For those with more knowledge. Is it still in the hands of CROs or is it in the hands of individual care providers in the OLE?
Going by ASM comments, Missling doesn’t really know when the peer review is coming out. With that said, if no review, do we just hear a rehash with some other tidbits?
Missling did say he would present the data, at least some, if peer review was really being delayed. Not sure who posted it or where I saw it. I’m not sure Missling wouldn’t jeopardize the article with it being so close. They would likely be able to creatively get around whatever embargo there is if needed.
Anyway, Marwan giving a rehash isn’t too exciting. I pray it’s more than that.
Maybe we’re seeing some learned lessons here. Under promising and over delivering on the MAA timeline. Relinquishing some duties to those that are more capable/reputable. We’ll see.
September isn’t too far away. The MAA and peer review seem like an inevitability at this point so at least we get to look forward to some SP movement. Shorts know the timeline as well so a little covering will be expected.
Maybe we can finally stop being a 4 dollar stock. Double digits seems like ages ago.
https://link.springer.com/content/pdf/10.14283/jpad.2024.112.pdf
Just tweeted out by Hampel
Hopefully we can set a new sp floor with the maa filing. Then the wait will be pretty long but at least it will be at a higher price. Afterwards there will be plenty of opportunity to take profit or sell calls to get some extra gravy.
If the peer review is good followed by the filing, I’d expect some good price appreciation. And as anticipation builds for the binary moment, some fomo should set in. Not expecting a rocket but it will be there along with some short covering.
Add in some progress on other fronts and we should be sitting at a respectable price. Of course it’s different for each. I’d be happy waiting in the mid 20s. Seems doable.
Thanks. I'm surprised he said they haven't seen any of the OLE data. Seems there is a lot hanging on the outcome.
Since when does fairness have anything to do with approvals.
Seems like pd/pdd trial is not starting any time soon since advances are still being developed.
I’m guessing they have seen a good amount of data already and it is confirmatory. Otherwise a pivot would be made like trying to file without it.
I pray we get some progress on other fronts while waiting. All this talk and little action is no fun. Especially when everything else is raging.
Seems that answer was for the FDA. Hope someone here can get some more color during the ASM.
Bring tomatoes just in case!
Missling did say he would file as soon as possible and since we are closing in on the 7 month time frame, waiting for the full OLE would greatly delay our submission. Submitting 6 month OLE data with the MAA seems more likely. Unless he's pulling a Missling which means take as long as humanly possible.
Are there any arguments against approving Blarcasamine besides for?
-trial may be too small and may be a little too short
-it was only a 2b/3 after a very tiny 2a
Seems that the arguments for approval vastly outweigh. The above can be answered with a confirmation trial after full approval. OLE can put some of that to bed as well.
Also for those that are more knowledgeable, it is my understanding that OLE data can be complied and gathered as patients finish making it a much faster process. Also, other measurements aside from the Adas and CDR can wait as they are less important at this time in terms of confirmation. If Adas and CDR are not what is expected, then the other OLE data will rise in importance and take much longer to flush out.
Either way, it is also my understanding that MAA is moving forward without waiting for any OLE data.
Thoughts?
For now, the MAA is like the peer review. It’s fake news until we see it.
Once we see it/them, sentiment will change rapidly.
I pray we are not reliving the past, where Missling was promising all of these catalysts by year end and achieved none. Déjà vu?
Even one of our analysts was like. Ugh. That’s a lot. Do you think all these are possible. Oh yeah. Missling said. And then flop. Missling learned his lesson and then stopped putting dates on our future catalysts.
No it seems he is back to his old ways. He didn’t say this year but is intimating a lot. Possibly too much. One of our posters listed 10. Can even half of these really be achieved?
Are getting stretching our resources again? Focus man!!
Our non published data might be our best hiring tool.
Missling: We can’t pay you much, but you will get some good options.
New Hire: uhm, I’m not sure. Wait you don’t even have an office?
Missling: No. but we’re doing some great things.
New Hire: uhm. Let me think about this for a bit.
Missling: Here is our unpublished Alz data. Take a look.
New Hire: Holy Fxxk! Where do I sign??
New hire skips down the hallway humming his favorite tune and dreaming of new mansions.
Varying degrees of being pulled in after being shown most of the data. Most means the most important parts without hiding anything.
-The data looks good. We think you should take a chance and file. And if the rest is good, you may have a shot.
-You should definitely file. Although not a slam dunk, we’ve never seen data like this especially in brain atrophy. We think you have a really good chance.
-This data is quite impressive. We are desperate for something safe and effective. The upstream MOA and peripheral benefits is what we need. Let’s get it going. We’ll support you along the way. What are you waiting for?
I’m guessing somewhere between 2 and 3. Being pulled is pretty strong language. Stronger than suggested. Pulling almost indicates a little convincing.
Maybe I’m reading too much into the word. Missling also seemed optimistic about the MAA profess. Almost as if they were ahead for once.
Insider purchases don’t bother me much as a 5-10k share purchase would be a token symbol. Living in NY is not cheap. Why toss 30k dollars down when you have options and time?
Peer review still annoying as hell. I’m not reading into the delayed ASM as anything unusual. He is definitely annoyed about how long it’s taking.
The company did a good job hiding the COO departure as the analysts would have surely asked about it if they knew. Would Toutain leave for a better package knowing what coming down the pike? There’s definitely more to his departure. High level people don’t leave at a time like this if they don’t have to. Forced to.
There’s writing on the wall. He saw it and left on his own terms. Career flop averted.