this is where we disagree
” these trials arent designed to hit toxic levels,,, etc”
yes they are
this is a toxicity boundaries study - designed specifically to determine human medical responses to each new set of cohorts as dosage is progressively increased until toxicity is detected
thats the prime object of the study
secondly the level of expected efficacy dosage is then compared to the safe data range
these data are essential to be established before stage three parameters for trials can be submitted and authorised to proceed
i can assure you that private research information i have been advised of indicates that 150mgs - inside the lower dosage range - is most likely to be sufficient for effective iv sepsis administration
But- lets not speculate and argue from lack of information on efficacy dosage to be officially determined from on phase three trials until we determine all the televant data points from phsse two!
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Ann: Positive Safety Data from Phase 1 Clinical Trial, page-41
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