Nanox explanation of the FDA timeline makes no sense

According to the latest prospectus and Q4 results call, the recent timeline of Nanox 510(k) submission goes like this:

• December 28, 2020:  The Review Organization recommended [Nanox single-source device] to the FDA for clearance
• January 1, 2021:  [Nanox] received an information request from the FDA through the Review Organization
• January 4, 2021:   [Nanox] responded
• January 30, 2021:  [Nanox] received additional information request(s) from the FDA
• March 2, 2021:  [Nanox] submitted a [complete and] comprehensive response.

If all of the above were true, Nanox should have received clearance no later than yesterday, March 8, 2021.  The explanation as to why is in two FDA guidance documents - 510(k) Third Party Review Program and FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals.  

Essentially, Section 523(a)(2) of the FD&C Act requires the FDA to make a final decision whether to clear the device or not within 30 calendar days after receiving a recommendation from the Review Organization.  Note that the final decision is confusingly termed "initial classification."  Any requests for additional information stop the clock until a complete answer is received.  So assuming the FDA got the recommendation on January 1, and then the clock stopped for 4 days or so and then for another 32 days or so, while FDA awaited for the complete responses, then the 30-day calendar deadline expired on March 8, 2021.

But Nanox press release says:  

The Company is in direct communication with the FDA and continues to expect that it can obtain U.S. regulatory clearance of the single source Nanox.ARC this year  (?!?!?)

And during the call, on March 2, the CEO rambled about "quite soon," "30 days" from the day of the call, and even "a couple of weeks" from the day of the call.  If Nanox disclosures were correct,  then it should have been within "a week."

So, in summary, Nanox is lying to investors about the status of its submission for clearance of the single-source device.  In fact, there are reasons to believe that Nanox may not have submitted anything to anyone for any clearance, or if it did, it was fraudulently.

And, of course, Nanox CEO did not miss the opportunity to confuse investors again by talking about approval (aka PMA) on the call vs clearance  (aka 510 (k) or pre-market notification).

We continue to believe that we will receive FDA approval of both our single source and multi-source device still within this year

According to Nanox own disclosures, the company has not submitted for approval but for clearance.  Or maybe this was a Freudian slip?  Any device that fails to get clearance is automatically classified as Class III, and would require a submission for approval, in which case Nanox has to supply sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.  That translates into years and millions of dollars in human trials.  Not happening this year.

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly single-source device), within 30 days of the call, just as the CEO said.  Outstanding FOIA requests may eventually shed light on the actual FDA timeline.