So, reading this article on NNOX about the big drop yesterday and saw some CYDY type things. Not saying they are lying about this but a few things I didn’t realize or seem suspect:
1. The FDA clearance given wasn’t even for the model/system that they want to commercialize.
2. They won’t ship the Q1 2022 1,000 devices but plan to do that by the end of 2022.
3. They blamed a supplier in the article but then mention that they are making progress (not done) transferring chip tech to a Korean supplier. Well, how can they be having supply issues when a crucial piece of the process isn’t even ready for manufacturing. Same with the FDA clearance on the system they actually want to sell.
4. The best nugget is that they haven’t even filed the 510(k) premarket notification to get FDA clearance. I’ll be honest that I don’t know the difference between this and the existing clearance they have on the single source system (not the one they want to commercialize). I read up on this clearance and the average timeframe is 6 months. The article mentions that they plan to file it in 2021. So, basically while they are blaming a specific supplier, they won’t have the clearance they need until the end of 2021 at the earliest and mid to late 2022 at the latest.
Just feels a little fishy to me in that they seemed to be all set ready to roll and now it seems like there’s still a bunch of hurdles before they can even start building what they promised 1,000 of in Q1 2022.
Anyway, was just reading it through and it just seemed off.