RE: So Cheap10 Feb 2021 11:24
I think TEK's statement witht the placing on 17th November suggested that guidance for 510k Clearance in H2 2021 remained on track. Guidance would have come from Belluscura, not TEK. The comment on that RNS suggested to me that they had not heard any different so that's what they penned as an update.
The RNS on 3rd December however quoted the Belluscura CEO :
Robert Rauker, CEO of Belluscura commented:
"Whilst we do not have a specific timetable, we have been told by the FDA that, as a COVID-19 treatment, the device will be given priority review and we are hopeful that FDA clearance will be granted this year."
His comments suggest it was unlikely to go through by the end of the year. Words like hopeful doesn't imply confidence that it will clear so quickly. We know that even emergency clearance takes 3 months on average.
Not the wordplay on the original RNS regarding guidance I agree but the CEO of Belluscura certainly wasn't hanging his hat on it