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Re: longtermgems post# 2207

Monday, 09/12/2016 1:04:49 PM

Monday, September 12, 2016 1:04:49 PM

Post# of 7900
Thanks. Courtesy of Dr. KSS

"Thus far in 2016, 89 percent of FDA-submitted medical device applications have been pushed back by the FDA with a citation of at least one major deficiency. This datum does place the plight of TransEnterix in interesting relief….almost as if it was gratuitously doomed.

That’s the highest in history.

The lowest was 40 percent in 2000. I don’t have data for n in either case."

So you have been in since 2013 and I saw you reference that we are in the top of the first inning?

I just wonder if they will not resubmit to FDA again?
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