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Alias Born | 08/07/2018 |
Sunday, February 17, 2019 9:03:42 AM
" They know exactly what the FDA expects, in the manner of document configuration and content. So, IMO, regarding the recent 510(k) submissions, that process should have been largely an exercise in cut-&-paste. The data is already there, but as I understand it, the trial metrics associated with men would be strip away, and the remaining trial data would be correlate to be women centric. Of course, it’s a given, that BIEL's folks are intimately familiar with that data, thus, in its relevancy and its idiosyncrasies. "
$BIEL$$$
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