RE: Affidx Publication1 Nov 2021 08:22
As we know we cant pinpoint when the file was submitted but we know a large useabilty study was done by Medusa at the end of May so if it was submitted in June thats 5 months in.
From NCYT RNS:
Further to the announcement on 29 June 2021, the Company's confirms there is a delay in the launch of PathFlow® COVID-19 Rapid Antigen, a self-LFT to detect SARS-CoV-2 antigens, previously expected in Q3 2021. This delay is due to increased demand for self-test approvals causing a backlog of tests currently under review by the Company's Notified Body. The Notified Body has communicated a delay of up to six months, therefore, the Company is also evaluating other approved options for a COVID-19 self-LFT.
So cant be far off....