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Wednesday, September 26, 2018 5:18:09 PM
CRYPTIC MEANING EMBEDDED IN THAT NEWS RELEASE
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"We are confident with the quality of our application, our technology, and our safety/efficacy evidence for the program said one of the applicants submitors Dr Koneru.
Dr Koneru further states, as I underscored in red, that "the FDA will work with the participants in an accelerated fashion by using "Breakthrough Designation"".
Of course he is referring to the July 12th submittal of the 510 (K).
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