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Wednesday, August 23, 2017 8:08:05 AM
Prepare and submit 510(k) application to
FDA and prepare technical file for CE Mark
and submit to European Notified Body
Q4 2018
Anticipated receipt of FDA 510(k) clearance
and CE Mark
H1 2019
Low volume production of pre-release systems will need to be happening (like... now!) to support training and pre-clinical studies - reasonable assumption would be at least two or three systems per location; this helps validate the production processes to be ready for formal production and sales to follow as soon as possible after FDA clearance. We could be on the market and selling units in less than 30 months from now. Just writing that last sentence makes me think great patience will still be required by all! 30 months... Will feel like forever as it ticks by, but once we get there, it will have all been worth the wait. Vegas, baby!
Message in reply to:
This company is 3 to 4 years away from sales and production. wouldn't FDA approval give this stock an immediate boost? Of course that is probably 2 years off
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