@LineMarker just to correct you. FDA De Nova application was...

@LineMarker just to correct you. FDA De Nova application was submitted in July 18 and company updated in November that FDA have responded with 11 points which MediBio needs to respond in 180 days. It’s Nowhere announced that another clinical trial is required. Can you please point me to the announcement which states that another clinical trial is required.

Also November ASX announcement clearly states that company will be submitting one or more applications for FDA 510K clearances in additional to response to original FDA De Nova application and company expects FDA 510K clearence within the first 4 months of 2019.


DYOR!