the completed trial (results due shortly) is specifically for their TGA and FDA submission. So unless the regulator specifically requests further trials then they wont do another trial is my understanding. Page 41 of the prospectus has the detail. This trial is very similar to the study they did in the Californian university approx 3 years ago. So the chances of it being a dud is low in my opinion
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Ann: Final Patients dosed in SPONTAN pivotal study, page-22
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