Slightly off-topic, but would the AVR animal study have been designed in a way so as to satisfy FDA equivalent in EU, S/E Asia etc or is it a FDA or bust type of report?
Im sure the FDA requirements would be up there with regards to stringency and results would be valid for most endpoints, but i know with other Bio-techs i'm in, sometimes different regulators seek slightly different end points to measure a products effectiveness.
Cheers
Ann: Key Animal Study for EFS Submission Completed, page-26
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