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12/05/16 1:16 PM

#89418 RE: uksausage #89415

Not-according-to-Stanford-study

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