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Re: biosectinvestor post# 427341

Friday, 12/17/2021 12:51:33 PM

Friday, December 17, 2021 12:51:33 PM

Post# of 701436
Thank you for elaborating Biosect. When people ask why is this taking so long, you have to think theough the complexities here and how different they are from a standard FDA process. I really don’t see any reason to complain about the regulator status, as we don’t know and can’t assume trouble. What I see is regulators collaborating with the company on elements of trial design, trial conduct, data analysis, manufacturing review, and distribution system management.

FUDsters will FUD anywhere there is doubt or lack of clarity. They cannot speak publicly for the US regulator. This is well known. So they haven’t and that includes clinicaltrials.gov
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