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Re: Gsdubb post# 6365

Monday, 03/24/2014 7:46:06 PM

Monday, March 24, 2014 7:46:06 PM

Post# of 106837
Just saw on BHRT "trials" tab on their web site that Mirror does indeed have a label, "Up to 35 sites OUS". So, guess that "OUS" is an official position then- N. America but no U.S.. So that answers part of the question(s).

Still, not sure if it relates to not registering the trial though if the "end game" is indeed, full FDA approval of the trial results and ultimately FDA stamp of approval to market/sell the product/process inside the USA? And again, if registering on clinical trials.gov relates to ability to get published in major journals, still seems pretty dang important? Again, real question seems to be, WHY NOT register it - there seems to be no downside, other than you must pass "approval/review".