I may be missing the point of your post @Surandy70, but it's well communicated that we're targeting commercial orders before end CY2023. Ie. Next 3-4 months. Before orders are secured in US, we will announce our distribution partner. Each of the 3 steps of announcing our partner(s), securing commercial orders and revenue generation should see material SP rises IMO as they remove risks.
As for the steps to secure orders, there is no further FDA approval for packaging or labels AFAIK. Once 510k is approved (which we've already received), "the submitter may market the device immediately". The CDRH subsequently regulates manufacturers, importers, etc, and not packaging or pre market related approvals.
Decision flow chart for 510k approval - refer to considerations on LHS:
AIMHO. DYOR.
The re-rate journey, page-50
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