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Wednesday, November 28, 2018 4:07:36 PM
When they received FDA clearance on knee and foot in FEB 2017, I remember they finally got wise and hired the dream team at GOODWIN PROCTER. I wonder if they were involved in this 510(k) submission. I also wonder if they were part of the submission of the innovative challenge.
I'm sure they are very expensive to hire, but because of the past history of FDA and BIEL, GOODWIN PROCTER was a great heavyweight to have in our corner.
Does anybody know if they went thru this process on the cheap - going it alone without the Dream Team? Because I dont believe FDA would dare compare the results being different from men than women.
Again, something that was learned, hiring GP, we got foot and in knee. I wish GP was at that May 9th meeting, because I think the FDA takes advantage of BIEL when GP isnt backing them.
I think we may have already started the party if we had them in our corner for both these recent submissions.
My comments above are simply my opinion and nothing more.
I'm enthusiastic at times however I am NOT a professional trader.
Please contact a financial consultant for investment advice.
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