Currently Importing and Full Support from Beckman25 Mar 2021 09:25
"We are currently importing into the USA while our FDA EUA has been applied for, which is permitted under FDA regulations. Lack of EUA reduces the potential customer base but we have proceeded on this basis with the full support of Beckman."
Beckman know exactly what they are doing, they would not have bought the initial $400k worth if they were in any doubt about being able to sell. Also consider the contacts Beckman and Danaher will have with the FDA, they will be hugely infuencial. IMO Beckman are either; very confident that they can sell a significant number of kits even without the EUA (I read 260,000 CLIA labs can be sold to) or/and they are very confident that the EUA will be granted.