Safety and efficacy isn't an issue as Painchek is the manual APS with only the facial assessment the point of difference as only this assessment is automated. So, the FDA will need to decide whether the risk outweigh the benefit of just using their current manual assessments as appose to Painchek but in a market which isn't familiar with APS so they will need to be trained in the other manual APS need for Painchek.......
Ann: Notice under s7(f)(ii) of ASIC Corporations Instrument, page-10
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