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Re: FoolishMoney post# 47481

Tuesday, 10/25/2016 7:53:13 AM

Tuesday, October 25, 2016 7:53:13 AM

Post# of 140477
I think their currently planned timeline is achievable if the right things are in place. The hardware design appears to be fairly mature except for the few odd things for Human Factors; that should be all that is left to get final hardware the design freeze. They can collect data in the meantime on the rest of the hardware, and finish usability focusing on the new pieces, with only limited regression testing on the rest of the system.

My bigger concern is the software at this point. I have heard almost nothing about it and I don't think Plexus is active for us at the moment (please let me know if anyone has heard otherwise).

If they are working with the FDA in advance (maybe their Early Feasability program) then 6 months from design freeze is a reasonable estimate. I have no idea what the CE mark entails except the general feeling seems to be that it is quicker and easier than a 510K FDA clearance.

I just need to convince my wife to left me drop a little more money on this stock before it climbs much more. I don't know what will actually trigger the PPS but I wouldn't mind having a little more in my portfolio before it happens.