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04/29/24 7:53 PM

#457916 RE: peeved #457858

Results are not good. I never understood why they did a 12 week trial with clinical endpoints rather than a smaller one-year or longer true P2 trial (I get that they did not have resources for a reasonably sized 18 month trial). Calling it a 2/3 for a 12 week trial was sketchy. As with many other small companies they went for cheap over quality -- they allowed a clinical diagnosis of probable AD (rather than PET or CSF proven), guaranteeing many misdiagnoses. This was further compounded by going with numerous non-neurology research sites (wonder if any were also BIVI sites; misdiagnosis rate by non-neuro is about 30% - though still 20% by neurologists compared to the gold standard tests). Perhaps the drug has some efficacy as mild AD patients with less misdiagnosis (ptau217/tTau ratio is almost as good as PET) showed ok 12 week data for ADAS-Cog 11 but with post-hoc analysis and multiplicity this could be a fluke. They did show that they can carry the higher dose forward. They need to raise a lot of funds so punishing dilution will come soon in order to finance a proper 18 month P3 that won't read out until 2027 at the earliest