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CytoDyn Inc CYDY
(Total Views: 634)
Posted On: 06/07/2020 4:21:44 PM
Post# of 154186
Posted By: havasu78
Re: lorbas #36896
While it might be true that Patterson "should be" blinded, what is also true is that blinding the blood vials as to the patient indentifiers creates a much higer likelihood that patient A results will be lost or attributed to a different patient. This event is such a serious data corruption that the FDA may regard it as a far worse problem than unblinding a highly sophisticated lab technician. As long as patient identifiers are maintained on each vial, you have a much better chance of sorting out any question that might arise as to which data goes with which patient.

In any event, whether Patterson is blinded as to patient identifiers on incoming vials is not a hypothetical question. Either The FDA requires such blinding and it is employed or the FDA does not require and it is not employed. Its one or the other, no hypotheticals involved. I don't know which it is.













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