Thanks for the discussion Sleven. I should probably preface that this whole Alzheimers angle is rather new for me so I'm basically learning as I go, and I appreciate the DD you've been posting.
Regarding pre-clinical long term outcomes trial and how it'd be design, looking at a failed one that finished this year (Eli Lilly's A4 trial): https://clinicaltrials.gov/study/NCT02008357
240 week followup (4.6 years) Outcomes include PACC scores, Tau and Amyloid biomarkers through PET scan.
Honestly I really don't see Amarin being incentivized enough to run a trial this long. However I do see a design like Clarity AD or Trailblazer-Alz 2 being far more attractive from a timetable point of view (18 month followup, Tau/Amyloid scans, and various cognitive tests). These trials were designed for early Alzheimer's however, not pre-clinical.
"Are you familiar with the most recent FDA guidelines for an Alzheimer's disease drug approval?"
I don't have great familiarity. You won't catch me complaining if the FDA approves an Alzheimer's indication off of Brave results. Generics will benefit, but so would we. Having said that, I would much rather we get that new indication in Europe though, for obvious reasons.
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