Replies to post #510037 on Anavex Life Sciences Corp (AVXL)

[boi568]

The point is larger: The conventional endpoints (MRI excluded) are bullshit, and particularly for this new class of drug. They are largely measuring irrelevancies and have never signaled a disease modifying treatment, just relatively temporary symptomatic relief.

[ohsaycanyousee82]

“To think that a relatively small trial, which missed its ITT endpoints, is going to educate regulators into accepting in-trial generated hypotheses centred on biomarkers that are, so far, neither established nor widely accepted, is unrealistic.”

Then why were you at a 75% approval chance prior to the “Trending” announcement?

[Jimbo50]

Hard to believe we’re in the 3’s . But better than 2 ‘s

[dennisdave]

Anavax post hoc trial EMA chair dance:

1. “Ok, the primary endpoints didn’t hit… but maybe if we slice SIGMAR1?”
CHMP: No, post-hoc genetics don’t replace endpoints.

2. “What if we show COL24A1? Look, an even smaller subgroup!”
CHMP: Still post-hoc. Still unacceptable.

3. “What if we combine two subgroups into ABCLEAR3?”
CHMP: That’s even worse you’re optimizing noise.

4. “What if we show ADNI comparisons?”
CHMP: External historical controls are not valid confirmatory evidence.

5. “What if we add MRI correlations?”
CHMP: Exploratory imaging ? clinical efficacy.

6. “What if we show 144-week OLE durability?”
CHMP: Open-label = meaningless for causality.

7. “What if we present it all together at CTAD?”
CHMP: We already reviewed the dataset. It didn’t meet regulatory standards.

😲 no? ok how about🥸 no? then 😎still no?