Yes - maybe the term "observational study" could have been...

Yes - maybe the term "observational study" could have been better as it doesn't sound formal - but read the MDC ASX announcement June 18 and it explains how it is part of the formal regulatory process - it is innovative and I guess could be argued a concession to help progress toward addressing the opioid crisis in US

also ---> see government TGA website:

https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000513112

it is also driving sales under SAS see ASX notice from company Nov11

hope this helps