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LBSR TO DA MOON

09/14/23 10:02 AM

#430393 RE: boi568 #430390

Is there any way to dispute AVXL's assertion that "the trial was successful" based upon the following information they provided within their PR this morning?

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.

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bas2020

09/14/23 10:05 AM

#430395 RE: boi568 #430390

Agree... scientific measurements of improvement are more valuable than subjective testing, especially in a short 48-wk trial.
There wasn't a pivot away from the OR calculations. They served their purpose in identifying the super responders. Nothing more to be added there.

For Anavex to PR the additional P2b/3 AD data ahead of Rett results, tells me we're going to see more AD results this year.
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boi568

09/14/23 10:47 AM

#430421 RE: boi568 #430390

Also, comparing today's PR to the December 1st PR, the revised stat for cognitive slowing moved from 45 percent to 43 percent improvement,* assuming the placebo decline figure remains the same. This is not a meaningful difference, but it does indicate the initial figure was not fully vetted.

* The company doesn't present it in those terms, instead referencing today a 1.783 point improvement versus an initially reported 1.85 point improvement (1.783/4.11 versus 1.85/4.11), or .43 versus .45).