Thursday, November 16, 2017 10:32:42 AM
I have been surprised to see some posters think that they have already applied for FDA 510k approval.
They may have started the paperwork but quite obviously cannot submit until trial data is available.
Then you have the FDA approval waiting time, and only God would know how long that would take.
Now I'm not sure if they can get fast track for something like this or not ? The trial data would have to be pretty convincing.
As far as domains PPS Analysis goes, I could easily see some of those numbers given the right marketing/didtrbution network, let's just say someone like Johnson & Johnson ?????
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