Monday, December 05, 2016 1:16:02 PM
RE: ...most companies spend well over $100m....
Costs related to winning 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
--> https://lmgtfy.com/?q=cost+for+fda+device+clearance
Compare the documents, Biel legal submission reads at an unprofessional level, while SEC "Division" reads at professional level.
Biel --> https://www.sec.gov/litigation/apdocuments/3-17104-event-115.pdf
SEC --> https://www.sec.gov/litigation/apdocuments/3-17104-event-116.pdf
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