Children and adult as the decline wasn't due to insufficient data to demonstrate safety and efficacy but benefit outweigh risk....
"ResAppDx US FDA update
After meeting with the US Food and Drug Administration (FDA) in January, ResApp expects to continue to engage with the FDA through additional pre-submission meetings in the second half of calendar year 2022 to progress clearance of a prescription-only software as medical device application to detect lower respiratory tract illness in children and adults. During the quarter, the company continued to work with its advisors to prepare pre-submission meeting request documents."
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Response No-vote letter update, page-57
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #