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.
Ann: Sale of Shares by Directors to Institutional Investors, page-255
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