how could one forget?
if this is one of the highest selling drugs of all time, we have a responsibility to examine the possibility that a vacuole in a rodent that was part of one of our pre clinical trial work was in-fact a common physiological phenomenon well documented in rodents in trials and not due to an adverse effect to ipps.
my personal view is this meeting will be like a set of dominoes that fall in our direction. Clearing us for 2mg/kg and THEN DMOAD label clarity!
PAR. SP, page-886
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