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Wednesday, December 27, 2017 6:29:01 PM
I can no longer find my post comparing our 57 week ADCS-ADL average to a recently failed BP trial in mild-to-moderate AD.
That trial had charts, included in my post, of their mean ADCS-ADL scores and corresponding historical controls. Our 57 week mean looked very similar to their historical controls for same period. Their historical control arm went further than 57 weeks, but I don't know of any data from which to extract the A2-73 ADCS-ADL mean score beyond 57 weeks.
Note that the historical control data mean is likely from hundreds if not thousands of patients in previous placebo/SOC trial arms. We should be able to compare any n size trial with similar patient profiles to that control database mean.
It was not a comparison that would stand up to scientific scrutiny, but not completely off the mark either. It indicated, with all the caveats you mention, that the A2-73 mean performance did not seem clearly superior to historical controls on SOC.
I don't think we can take anything for granted yet. including your assertions of beating SOC. We can hope that the final KEM analysis will indeed clearly identify meaningful objective inclusion/exclusion criteria, in which case our chances of success should markedly improve.
IMHO finishing that analysis with some confidence in the results, is what we are most likely waiting for rather than a myriad of fanciful theories.
That trial had charts, included in my post, of their mean ADCS-ADL scores and corresponding historical controls. Our 57 week mean looked very similar to their historical controls for same period. Their historical control arm went further than 57 weeks, but I don't know of any data from which to extract the A2-73 ADCS-ADL mean score beyond 57 weeks.
Note that the historical control data mean is likely from hundreds if not thousands of patients in previous placebo/SOC trial arms. We should be able to compare any n size trial with similar patient profiles to that control database mean.
It was not a comparison that would stand up to scientific scrutiny, but not completely off the mark either. It indicated, with all the caveats you mention, that the A2-73 mean performance did not seem clearly superior to historical controls on SOC.
I don't think we can take anything for granted yet. including your assertions of beating SOC. We can hope that the final KEM analysis will indeed clearly identify meaningful objective inclusion/exclusion criteria, in which case our chances of success should markedly improve.
IMHO finishing that analysis with some confidence in the results, is what we are most likely waiting for rather than a myriad of fanciful theories.
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