GREY:ATBPF - Post by User
Comment by
IrishCanuckon Aug 12, 2021 9:48am
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Post# 33691018
RE:RE:Phase 2 trial more than likely
RE:RE:Phase 2 trial more than likelyThey definitely hinted a Phase 2 is likely to be repeated with lower doses... WHY that's required I don't understand besides formality. If 250mg passed at 2 weeks 75mg should definitely pass at two weeks, if the duration is the concern then repeating a study at two weeks makes zero sense. Just continue the AME study for four weeks with 75mg and 50mg (not an expert, but that would be my strategic pitch to Health Canada).
"Idiosyncrasy" is the term we're looking for for the 3 patients
nozzpack 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..