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I was just telling a few investors the same. Lundbeck!!! Maybe a premature prediction as it was based on the Memantine and sigma 1 agonist drugs proving synergistic in this new paper. Been months since I came to ihub, not sure if this was previously posted:
Fluoroethylnormemantine (FENM) shows synergistic protection in combination with a sigma-1 receptor agonist in a mouse model of Alzheimer's disease
https://www.sciencedirect.com/science/article/abs/pii/S0028390823003234
How does the trials success, depend fully on the subgroup analysis, when we have the TLR, and this data met all endpoints with combined doses?
Assuming we get AA, Will our partner want to control and run our phase 4? Or will Anavex continue to be the lead sponsor and trial designer for AD?
Thoughts?
Or because of the Acadia approval. The call today noted a near $600k/yr price tag for Daybue. I think it’s safe to say investors are immediately seeing an undervalued opportunity in AVXL - for the Rett indication alone.
If Daybue is worth $600k/yr, Blarcamesine is worth minimum $600k. I was never projecting Blarcamesine to sell for 600 on the low end. While it would have been better to get to market first, can’t complain about the numbers if approved.
You aren’t really asking these questions. And even if you were, there is zero point in answering them. Nothing anyone says here will even slightly change your mind.
Where does it say that amyloid and tau reduction was used as a SURROGATE ENDPOINT?
Did Lilly use pet scans/plaque removal as a surrogate?
If you think missling will F this up then it doesn’t matter how much you “believe” in the science. Get out before this goes under a buck. Right?
Very much agree with this
Who is expecting the full TLR by Thursday?? Not seeing any posters making this prediction.
Highly doubt they present full TLR at the JPM.
Missling will announce the data when it is ready. Unless he puts it out tomorrow, JPM will be a rehash. All good.
No where in the Lecanemab AA is anything correlated or linked to lower amyloid plaque levels. The Aduhelm approval, this correlation was made, including by the FDA when they explained/defended the AA.
How are you so sure that amyloid levels were used as the AA surrogate endpoint for the lecanemab approval??
Question, would there be any reason for a trading halt in the morning? Thanks
A precision medicine n=300 trial would be redundant. What would that prove? We just ran a 509 patient trial, and have significant and meaningful data with both doses combined. Another trial makes no sense!
Ok. But an additional trial is needed right?
Zig is saying an additional 1500-2000 patient ph3 trial is up next.
I just want clarity around the different speculation.
Be less concerned with my mid year prediction and more concerned with whether or not this AD trial will be pivotal or not. I know where you stand - 2000 patient precision medicine trial accounting for genetic biomarkers, correct?
The timing isn’t as important as wether or not they can submit an nda based on these AD results. If these results allow for an nda, getting one to the fda in 2023 will happen.
And you and others are already talking about 2000 patient phase 3 trial. If you’re going to reference the PR to make a point, then show me Where in the PR did it state anything about a large n trial? It didn’t say anything of the sort.
What we do know is missling has repeatedly said this trial is potentially pivotal. If the data is great it’s likely pivotal, if the data is mixed, it would likely need another phase 3. Being our data slowed cognitive decline more then anything seen before, it’s reasonable to predict this trial is pivotal.
You’re assuming an unlikely scenario. The probable result here is anavex will get an NDA submitted by mid 2023
Yep. And then there are some with their life savings here and yet on a daily basis publicly trash everything about the company, especially management, right after historical AD trial results. It’s an interesting angle to say the least lol
AF was correct? Woah lol
Your making a lot of sense Frrol. I find myself agreeing with you a lot these days. A nice change!
Yo, Bio, where you at?!
I see they patted themselves on the back a few times in the summary. This is more about the Association then it is about informing the public on the CTAD AD developments.
Mycroft, great post. I love your straight shot logic. Nice to have you back, sir.
you have no idea if another phase 3 trial is needed.
Exactly right Frrol
Don’t discuss the data with fellow colleagues who share similar expertise in medicine and clinical trials. Makes much more sense to be on message boards with small time retail shareholders, and trying to influence the stock. Like why weren’t you at CTAD, Doc? Sincere question. Another phase 3, another phase 3, another phase 3. Thank you for going right back to the same narrative.
Now I know why every time I go to the doctor I wait 20-30 mins to be seen.
no chance. trading halted and news pending as we speak
AF is definitely coming out with a hit piece
Just following the ceo’s public comments that anavex is looking at doing a fragile X basket trial. Can you not acknowledge this? This isn’t something people just started saying. This is coming right from missling
For fragile X, yes. Unless things have changed? Missling is quoted in describing the basket trial for fragile X due to the many variations in this disease.
Imo they wouldn’t want to merge AD top line with an earnings call. They will want to do the earnings call prior to the readout. My guess is readout comes Monday afternoon after close, with a cc after ctad, maybe Monday dec 5.
We shall see
This is nonsense
I believe missling misspoke about the quasi basket trial regarding 3-71, which I believe he clarified in subsequent call. His clarification referenced the quasi trial for fragile X, and the many forms of this disease. The 3-71 trial will not be a basket trial, but rather 3 separate trials for FTD, AD and Schizophrenia.
Not only that, but the company has diluted to fund operations, so the OS has increased over the last 7 years. If for example institutional ownership has remained at 30%, they are in fact buying. I know you know this, just pointing it out
Probably quarter 2, being the rett org updated Excellence enrollment timelines (last week?) to go through the end of the year.
These other smaller PRs, after Hitting all endpoints in AD, would not cause the share price to tank. That’s ludicrous