It's never been clear whether the CSF studies are being performed in all 450 patients or a subset of them. Requirement of 2 LP's will certainly hamper recruitment. If all patients have pre and post 48 week CSF analysis then this could serve as a biomarker to allow approval with AA. If only a small subset of patients were evaluated this way, the pathway seems less likely.
AB40/AB42 ratios or Tau/AB42 comparisons are well established as diagnostic biomarkers with > 95% concordance to PET scans. NFL is more a general marker of CNS damage (serum NFL may have value as a response biomarker in MS so it's less specific for AD -- NFL players also may have increased NFL) and I'm less familiar with the other markers but a couple of them have been included in other AD agents's small 2a studies (i.e. SAVA, ANVS)
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