Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Missling is the head porcine makeup artist. His data hijinx have been going on since he's been with AVXL. For those waiting for subgroups..."fool me once shame on you, fool me 57 times...".
Also, he waited until the New Year precisely because he didn't want tax loss selling
"Missling and team chose Odds Ratio as a relevant facet of the endpoints, however dubious when not seen in perspective of the classic expected EOT vs Basline scores and p-values"
Thanks, since he was under this crunch time, he was unprepared to do it in the classic way, so he should have stepped away logically....he had to know the stock would be pounded down...it's a serious problem and I have to assume that this CRO was not a good one..
Affect is routinely used as a noun in medicine...it is the outward manifestation of an emotional state. The better dictionaries include this definition in addition to the verb uses. Medical dictionaries should all have it...would think it would be the first definition given in most cases.
Sure, but keep in mind that patients were on 4 different dose levels throughout the P2a trial and its extensions per figure 1a from same paper: 10mg, 20mg, 30mg and 50mg.
You lost your credibility when you posted an image by Jesse Brodkin
Yes an excellent short paper giving an insight to why some of us are more sceptical than most about Anavex data conclusions to date and avoid silly fantastical extrapolations.
OFP, be careful as there is a lot of foolishness and uninformed posters out there ... maybe, even some bots!.
See Tred's post.
Because of the placebo effect, some in Group B imagined that they improved. "I THINK I'm better." When told that they had been taking the placebo and were offered the real drug, quite reasonably they would think some form of "Yes. I've got nothing to lose."
That's one way to look at it. But I see something different.
I see a CEO who has navigated a difficult path. Over the past 7 years there have been countless hit pieces and short attacks, numerous baseless allegations and frivolous lawsuits, a pandemic, a recession and several competitors' drugs biting the dust to get the company to where it is today: front and center at CTAD 2022 presenting data about a novel MOA for treating Alzheimer's disease.
Good call Doc, but why would a company wait till the conferences to release bad results? In another word, if a company has results but waits till conference to release, isn’t it an indication of good results?
Think partial reaction to axosime news..
“Met primary endpoints”.
This run up has been great. Sold Oct puts, bought Jan...Oct puts just expired worthless.
Playbook strategy comes due...Back into the AVXL game with a hedged option strategy. Betting the emphasis on subgroups, cherry-picked data, and convenient exclusion of drop outs has generated optimism out of proportion to prospects.
With decent data wouldn’t Missling be able to...
Well that would require a Spanish and English speaking dyslexic employee I suspect. Or that EMA copied the Spanish site, which seems likely as the Spanish text is included and translated to English.
Thought I am not qualified to diagnose dyslexia in Spanish.
A DOCTOR REQUEST DOES NOT MEAN THE TGA WILL GRANT APPROVAL TO PRESCRIBE OR AVXL WILL SUPPLY A2-73 TO ANY AD PATIENT!!!!!!!!!!!!!!!!
Agreed, the TGA probably sees a high probability for success due to sleep quality and the glutimate response in the first Rett trial.
The entire purpose is to get "unproven" but safe medications with a high probability for success on the market years earlier.
Motivation:
The granting of provisional approval is dependent on
Promptly, a nice new word to debate - love it!
On a timeline order where does promptly sit compared to soon, imminent, mid-year and this quarter, next quarter or even end of September as applied by Anavex?
I don't even know where and when to start placing it, ideas anyone?
Last night I was cooking a recipe that called for thyme, that had me slow down and think for a while. This whole debate I think has long term nasty side effects on my neurons.
Quite possibly the reason has to do with needing to do an EEG setup to make the ERP measurements. That would require a trip to a clinic with the required equipment.
As I understand it the other end points can be done via a computer which allows them to be done from home. So dropping the ERP may be a function of making the participation easier for the subjects. Not to mention the difficulties that Covid imposes.
The ERP data in the 2a was inconsistent
You may be interested in this entirely ERP based observational study: https://clinicaltrials.gov/ct2/show/NCT04025502?term=Anavex&draw=2&rank=10
But you are right a bit odd why an improved version of ERP, as above, is not part of the current interventional studies.
4x is correct. It is the main conclusion of the P2a AD REPORT of March 2019 after 5 years of OLE extension data. Your comments are hot air.
Results still busy being cherry picked?
The video I posted helps one to understand how blarcamesine can affect multiple CNS indicatons. Understanding the microbiome helps to prove our thesis.
ANAVEX has a drug that actually activates the sigma 1 receptor with a magnitude 4x of anything else in the system!
Or, it's just a small biotech exploring potential biomarkers for a licensed drug it's trying to develop.
Ariana and the microbiome study were added.
As people who (still) reads my posts will know, I have often said that the gene variant findings although highly stat sig are not representing any meaningful clinical impact.
These are not "Shots in the dark". There is very good murine data and data from the other trials to suggest efficacy beyond the other Sigma 1 agonists. The 6 person Rett trial was with quite low doses and all 6 subjects showed a clear response for example.
What's left? There are different effects on agonism from different drugs. 2-73 is an allosteric modulator of Sigma 1. that can make a big difference.
Then there are the Muscaric receptors that get involved.
So, in answer to your question, a lot is left.
but have a shot at this article:
https://finanz.dk/anavex-is-likely-to-report-positive-parkinsons-disease-trial-results-for-a2-73-increasing-share-value-nasdaqavxl/
This is a post that should come after failed trials results, not before positive ones.
Provide the link that shows the TGA is not willing to grant Cat B approval to others who take the oppurtunity to apply for it.
Seems the perfect background on which to make a qualified statement on the likely outcome of a clinical trial.
You're confusing endpoints (eg, motility) with subgroups (eg, SIGMAR1 variant).
pre-specified subgroup analysis and the prospects of a well designed P3 precision medicine trial selecting on the best responders
In that case I think I can safely say I am way more optimistic about the prospects for A2-73.