RE: Undervalued, +57% and Still Rising3 Feb 2022 15:33
@dominic2002, The Half Year Report stated they were making good progress on the self-test ce-marking [1] and today ODX delivered. They also mentioned very clearly the two applications to the FDA, self-test and professional use [2]. As explained before they are in progress with the professional use.
GL
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1. "Self-test CE-Marking making good progress, with other regulatory approval processes ongoing"
"We are making good progress in the process of seeking CE marking for self-test use for our COVID-19 Antigen test. We have now responded to all questions and requests for further information from our European Notified Body, who will now continue to advance their review of our submission. However, the timeline for this approval remains uncertain."
2. "Our technology partner, Mologic Ltd, continue to progress their submission to the US Food and Drug Administration for Emergency Use Authorisation, for use of the professional-use test under both the VISITECT® and Global Access Diagnostics brands. We understand additional US trial data is required in support of this submission and that this is in process.
A feasibility study as to the process, timelines and likely high-level costs associated with the submission of the VISITECT® COVID self-test for FDA approval is currently underway, although the cost of gaining approval may be prohibitive."