Great question @dougfr would love @Red bar to share his thoughts as well...
From Ann..
Principal investigators at the hospital sites and the managing CRO, INC Research now require two weeks (until the week ending 16 June) to close out recruitment before final data verification begins.
“Recruiting 1,157 paediatric patients in less than five months is a significant achievement and we are pleased to have reached the target enrolment numbers for all of our planned endpoints, which span a broad spectrum of childhood respiratory disease,” said Tony Keating, CEO and Managing Director of ResApp Health.
Following this initial phase, clinical and radiologic adjudication will be conducted for the remaining patients and final source data verification site visits will be performed by INC Research. The analysis team will then prepare the top-line results, which are expected in July, while in parallel ResApp and its FDA consultants will finalise the de novo submission for ResAppDx. .............
My interpretation...
Could be early july, my gut says mid July for results release & submission ..tick tock rappers.
- Week ending 16 June until complete recruitment close out ( clinical & radiological)
- Top line results expected in July
- Parallel resapp & FDA consultants to finalise de novo submission
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