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Re: joshalex5 post# 62561

Thursday, 05/12/2016 7:46:49 PM

Thursday, May 12, 2016 7:46:49 PM

Post# of 463682
There should be no unease about data. We already know that 11 of the first 14 patients to reach twelve weeks improved their ADCS-ADL scores, with an overall mean or median (presentation does not specify as far as I can tell) improvement of over three points on the scoring scale. Nothing like that has ever been seen before in an Alzheimer's trial. ADCS-ADL scores correlate directly to caregiver observations, and as we have heard repeatedly in general reports, the caregivers in this trial have been very positive, even effusive, regarding the effect of 2-73.

Even if the other measures turn out lackluster at 12 weeks (though that would be extremely surprising, particularly with the Cogstate data), ADCS-ADL scores are going to be good, period, because the caregivers have essentially already told us so (and the interim 12-wk data confirms).

Anavex 2-73 will be approved by the FDA for its ADCS-ADL improvement in P3 regardless of the other cognitive measures. We have every reason to believe the other cognitive data will also be good, but with ADCS-ADL, we know it already, and that is enough. There should be no unease about the quality of the data, just impatience to get it (which I most definitely feel along with everyone else).
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