Replies to post #481222 on Anavex Life Sciences Corp (AVXL)

[sab63090]

Investor
Hard to argue with those highlighted facts!

Seems as though Missling stepped into some mud along this journey as you have suggested. Maybe Dr. Jin and Dr. Sabbagh have improved his position?

You might have noticed that Dr. Talavera is a SVP which seems to be the highest title within Avanex under the CEO...I think Dr. Jin is titled a VP even with his expertise and experience at the FDA....

With larger firms the Executive VP is the level above SVP...and I have not seen anyone with that designation.

I did notice that Missling seemed to elevate and allude to Dr. Talavera in his presentation, so I guess he likes him A LOT. I do not remember him mentioning anyone else by name. That seemed odd to me.

[WolfofMia]

Speaking of which, why do you refuse to answer these two very very simple questions:

Which drug is safer to you, mabs or our small molecule?

If both were approved, which one would you treat YOUR FAMILY member with at early stages of AD?

[williamssc]

When EMA approval comes this year you will be able to relax, maybe.

[imho]

Investor,

I used ChatGPT on your post.

1) I asked if the poster is right? ChatGPT said:

The message board poster questions the accuracy of Anavex's statement that their Phase 2b/3 Alzheimer's disease trial met both co-primary endpoints. The trial's co-primary endpoints were cognitive function (measured by ADAS-Cog13) and functional abilities (measured by ADCS-ADL). According to the trial's pre-specified statistical analysis plan, success required both endpoints to achieve a p-value of less than 0.05, or at least one to achieve a p-value of less than 0.025. The reported p-value for ADAS-Cog13 was 0.0226, meeting the criterion. However, the p-value for ADCS-ADL was not reported, and subsequent disclosures indicated that ADCS-ADL did not reach statistical significance. Therefore, the trial did not meet both co-primary endpoints as initially claimed. The poster's conclusion aligns with the available data, suggesting that Anavex's initial statement was inaccurate.

2) I then asked:

"Yea but the company later clarifies:

The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.

ChatGPT said:

In Anavex's Phase 2b/3 Alzheimer's disease trial, the statistical analysis plan outlined specific criteria for determining the success of the co-primary endpoints:

Success Criteria: The trial would be considered successful in meeting the co-primary endpoints if:

Both endpoints achieved a significance level of P < 0.05, or
One endpoint achieved a significance level of P < 0.025.
Secondary Endpoint Evaluation: If only one co-primary endpoint met the P < 0.025 threshold, the secondary endpoint would then be evaluated at the same significance level of P < 0.025.

In the trial results:

The ADAS-Cog13 (a co-primary endpoint) achieved a P-value of 0.0226, which is less than 0.025.

The CDR-SB (secondary endpoint) achieved a P-value of 0.0175, which is also less than 0.025.

Given these outcomes, the trial met its predefined success criteria by demonstrating statistical significance in one co-primary endpoint (ADAS-Cog13) and the secondary endpoint (CDR-SB) at the P < 0.025 level.

Therefore, when the company stated that the trial met "both" its co-primary and key secondary endpoints, it was consistent with the statistical analysis plan's criteria.

IMHO (I am just the messenger - any and all wrath should be targeted at the failings of ChatGPT)

[pcguy]

When quoting something it is generally best practice to provide reference for context and to accurately represent what was actually stated.

In your post you provided a quote from Anavex which you highlited in red that stated:

The trial met both its co-primary and key secondary endpoints,

Then you later quoted the company as stating:

The bit in red clearly shows that this "The trial met both its co-primary endpoints" was untrue!

When did the company state these exact words?

These are two different statements. Your second quote left out "...and key secondary..." from "The bit in red..." i think this was just oversight, but it is information like this that can make people perceive the company as being misleading. It is inaccurate by slight omission and then "quoting" the company as a matter of fact. It is the very thing that some people accuse Anavex of doing, like you did in your post.