Questions about timing

Nanox filed a 6-K today, claiming:

On August 12, 2021, NANO-X IMAGING LTD (the “Company”) received a request for additional information from the U.S. Food and Drug Administration (the “FDA”) concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC. The submission file is placed on hold pending a complete response to the FDA’s list of deficiencies. The Company’s response is due within 180 days from the date of the request for additional information.

The Company plans to respond by the due date which is 180 days from the date of the request for additional information. The Company expects to continue to optimize and develop further features of Nanox.ARC and is considering submitting an additional 510(k) application for the next version of multi-source Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA’s feedback on the first version of the multi-source Nanox.ARC.

This confirms that the Arc submitted for pre-market notification is not the one that Nanox plans to market, just like the Nanox.Cart.

But what is more important is the timing.  Nanox did not mention any of this on its Business Update webcast on August 16, which showed improved images, some new tube prototypes, and some fancy user interface, but no technical data and no evidence that the Arc prototype is actually working.