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The reality is that's a spin hit piece...
Stay on topic; we were talking AD endpoints.
Say what?
Its all about present and future market cap and got zero to do with O/S.
You're spot on, Wolf. Especially this line...
They share the same Cabal!
Where do you come up with this nonsense? There has been no change in endpoints... just more detail in the evaluation, plus biomarkers. ORs are also still valid!
From clinicaltrials.gov, last updated 8/21/23... 450
STUDY START (ACTUAL)
2019-10-10
PRIMARY COMPLETION (ESTIMATED)
2024-07-31
STUDY COMPLETION (ESTIMATED)
2024-07-31
ENROLLMENT (ESTIMATED)
450
How would you know? LOL So lame!
I would be careful of those LLM answers, especially because there is no references to which trials and documents went into concocting the answer.
You're missing the forest for the trees...
ORs were prespecified, met endpoints, and highlighted IMPROVED responders. FDA will be impressed.
Cog and CDR also met stat. sig. mean score improvements. FDA will be impressed.
Cog and CDR found to be even more significant with p-values < .025. FDA will be even more impressed.
Key biomarkers found to provide objective and measurable effectiveness. FDA will be most intrigued.
Oh... and the safety profile is second to none, easily administered and inexpensive!
Add it all up and it spells... APPROVAL!
OLE becomes the confirmatory trial.
It's working out perfectly for doubling one's position. Tell your handlers THANKS!
You need to look at the most recent FDA guidance. Dr. Jin is correct in the recently PR'd data.
So you can stop trying to spin it negatively.
Your idiocy is beyond belief.
Likewise... ready and waiting.
More FUD spin is all that we expect from you... You have a job to do and I'm sure you're paid very well... in Judas coins.
Appreciate you admitting it's your handlers who control the price...
The people in charge of the price
Ignore you!
I believe Missling stated it based on discussions with, either, the FDA or Dr. Jin... who certainly would know if it's acceptable. It would certainly provide the longitudinal confirmatory data as any other trial would... and will complete next July.
We'll soon receive all the data, including subgroup analysis, and all of this combined will likely be quite compelling to the FDA:
• Odds Ratio of ADAS-Cog meaningful improvement in cognition at threshold of -0.5 points or less (90% CI) 1.839 (1.17, 2.94) P = 0.015
• Odds Ratio of ADCS-ADL meaningful improvement in function at threshold of +3.5 points or higher (90% CI) 2.67 (1.17, 6.13) P = 0.0255
• ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks
• Mean difference in ADAS-Cog score change of -1.85 points
• Compared to placebo, ANAVEX®2-73 (blarcamesine) reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by CDR-SB
• ADCS-Cog and CDR-SB (p < .025) proving further significance of stat. sig. improvements and trial success.
• Identification of two key biomarkers (Aß42/40 ratio and brain volume stabilization) for AA pathway option.
The confirmatory trial (OLE) is already underway... this situation is very likely, as mentioned by Missling.
One has to recognize the attempted spin from these fraudsters.
They DID NOT pivot!
Cog and ADL ORs were significant (per the SAP) to highlight patients who IMPROVED and remain so... no change.
Cog and CDR scores were stat. sig. and remain so...
Further investigation on Cog and CDR identify better results than initially found, with P < .025
The biomarkers discovered were identified back in Dec... and brought to light in the 9/14 PR.
There was no pivot... just additional detailed data... and ALL of this data will be presented to the FDA.
It's not that hard.
Never... never give a FUDster a break.
You're such a blathering idiot. Please stop with your pompous posts.
Jin informed you that your statement is absolutely false...
we clearly have co-primary endpoints and both need to be hit.
Ridiculous blather! There was no pivot, just additional detail of the successful results, plus identification of key biomarkers for AA pathway.
Psychotic idiot.
Idiot.
You've done revealed yourself as a FUDster. Keep that in mind when you post next.
Good riddance, FUDster! Don't bother coming back.
You're so full of schitt it's not funny.
We know a FUDster when we see him... and you are him.
Me too... it's rather obvious.
Congrats... you got 100% FUD "Likes". You're on a roll, Dr FUD.
If you're siding with kund, then you're either a kook or a FUDster.
He's never had a rational valid post ever... only pure FUD nonsense.
It's what he's paid to do.
Not afraid... active living and healthy eating are lifestyle choices. To do otherwise and ignore the potential harm is quite risky.
Gotcha. If the collusive shorts are buying instead of covering now, then is there another takedown planned?
Sounds rather risky when the outcome of approval is rather imminent.
Yes... good quality organic olive oil, avocado oil, coconut oil, pastured (Irish) butter, ghee and macadamia oil.
Good fats, even saturated, are very healthy for you. The past myth of "low fat is good" has been debunked.
The purpose of borrowing shares is to short.
stay away from sugar
I think it's a good situation that most all shares have been lent out/shorted long ago... not much left to borrow and short. This should set up well for continued covering...
Yes, that's what Anavex (Jin) had stated, in the PR... thus, making ADCS-ADL immaterial, even if good.
• Odds Ratio of ADAS-Cog meaningful improvement in cognition at threshold of -0.5 points or less (90% CI) 1.839 (1.17, 2.94) P = 0.015
• Odds Ratio of ADCS-ADL meaningful improvement in function at threshold of +3.5 points or higher (90% CI) 2.67 (1.17, 6.13) P = 0.0255
• ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks
• Mean difference in ADAS-Cog score change of -1.85 points
• Compared to placebo, ANAVEX®2-73 (blarcamesine) reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by CDR-SB
• ADCS-Cog and CDR-SB (p < .025) proving further evidence of stat. sig. improvements.
• Identification of two key biomarkers for AA pathway option.
I couldn't get past the first nonsensical sentence of your FUDiatribe.
Missling knowing that the company did not meet all endpoints and have a likely fail in sight?
Not true...
we're going the AA route because a full approval is pretty much impossible without hitting it.