It says in the investor presentation catalysts slide that:
'Commence FDA de Novo clinical trial for Adult Product - Q1 2020'
'FDA de Novo Clearance for US market - expected 2H 2020'
From what it reads, we now need to do a clinical trial for the Adult app, where the data will be used for the de Novo submission. Hence movement out slightly of the de Novo clearance.
It says in the investor presentation catalysts slide that:...
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