1/ $NNOX FDA update:

FDA asked for more info related to:

"certain deficiencies and questions, including requests that the company provides additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device."
2/ $NNOX "plans to respond to these requests promptly."

$NNOX also "plans to submit an additional 510(k) premarket notification to the FDA with respect to the multiple-source Nanox.ARC and the http://Nanox.CLOUD  during 2021."
3/ **IF** cleared, management now targeting "1,000 Nanox Systems by the end of the first quarter of 2022"

The original goal was 1,000 systems installed by the end of 2021, so the goalpost got moved back 90 days
4/ Down ~6% pre-market. I'd actually expect a much bigger decline.

Here's link to 6-K

5/ I'm NOT an FDA expert, but I do know requests for more info are not unheard of

A 90-day pushback in 1,000 system deployments suggest management thinks this is a ~3-month delay

But, their credibility will take a hit today, so hard to say for sure
6/ I've said it 100 times, and I'll say it 100 more



The risk will decrease significantly post-FDA approval.

But, as you can tell, that's NOT a sure thing.

Allocate accordingly.
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