RE:RE:Phase 2 trial more than likelynozzpack wrote: That is not my reading.
Everything went fine at 75 mg.
These 3 patients may have had several diagnostic outcomes that could be unrelated to dosage in which case their results can be omitted from the trial results .
So, that is a necessary process which might turn out to be of no concern for the 100 mg dose.
That there were no safety concerns in previous trials suggest that these three are outliers whose response was not dose related..
Stauffer himself said AME results were drug related, more specifically dosage related. Yes, 75 mg was no issue for AME but they need to prove full safety and efficacy with a Phase 2. They'll do 50mg for sure and maybe even 25mg if they're smart. They stated a number of times how surprised they are with the potency of the drug.