Tuesday, August 20, 2019 7:59:03 AM
well CONSIDER THIS for starters...
Costs related to 510(k) clearance for a medical device that were directly related to satisfying Food & Drug Administration rules average $24 million, according to a Stanford University report.
More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.
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AND THAT'S FOR ONE DEVICE
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I look at it this way... you're a small company,
limited cash, limited staff and resources...
you have FDA on knee and foot...do you direct resources
on developing knee and foot or on going for full body FDA,
giving you access to back and neck relief in the USA (the
big market) ...while you focus on FDA, also develop Europe,
which isn't restricted by FDA.----oops CA requirements (a
casualty of spreading resources too thin) ...
I believe CA in place explodes sales in Europe, and
full body in USA will free all resources to focus on sales
alone and blow this stock price through the roof.
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