We have not seen dose dependency data beyond 5 weeks, no PK/PD data yet, no clarity on interaction between A2-73 and Donepezil, no longitudinal data beyond 57 weeks in the ongoing open label adaptive trial design now with some 2 years of data.
Meanwhile, Ariana has been employed and DNA/RNA profiling has been added to the inputs along with: Baseline scores, score evolution, Population PK, clinical assessment, vital signs, co-medication and more..
Anavex switched to calling themselves a Precision Medicine company somewhere along the trajectory.
I say all of this is precisely to avoid the surprises that can stem from an old fashioned linearly designed P3 study. Anavex is working not to end like Neurotrope and countless other failed P3 trials.
Instead the AD P2/3 trial is being designed to take into account non-obvious uni-directional or multiple variable correlations that can not be identified with traditional statistical stratification methods. Data mining – why KEM?
This way inclusion/exclusion criteria and endpoints can be selected with higher level of outcome certainty and reduced risk of surprises.
That's why it serves no purpose for Anavex to publish piecemeal data, but rather ultimately a coherent trial design and probably pre-agreed approval path e.g. SPA or similar under new rules/guidance that we may be awaiting.
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