I still believe that the FDA PCH is just a delay tactic (or CYA/"don't make waves" indecision) with safety in dogs as an excuse. The phase 1 data for PBT2 showed a good safety profile up to a dosage of 800mg. Below is the statement and link from 2006.
"
May 15, 2006
mce-anchorPrana Biotechnology announced pooled results from their phase I development program for PBT2 for the treatment of Alzheimer's disease (AD). These trials enrolled 55 young male volunteers and 32 older male and female volunteers; they were designed to investigate the safety, tolerability and pharmacokinetics of single and multiple oral doses of the drug. Preliminary data yielded a positive tolerability profile for doses up to 800 mg, with no significant differences in rates of adverse events (most common events included headache, gastrointestinal disturbance and somnolence). Maximum tolerated dose was not reached. Pharmacokinetic data indicated a rapid absorption profile, with peak plasma concentrations achieved within 3 hours of administration, a linear absorption profile following single doses of the drug, and little drug accumulation in multiple-dose regimens."
Link: https://www.centerwatch.com/clinical-trials/results/new-therapies/nmt-details.aspx?CatID=11
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