layman's explanation, page-4

With improper data entry (due to daylight savings adjustment being neglected) the recorded information was not 100% accurate. These errors, ever so small, are not acceptable because the subject being recorded (oxygen saturation % levels) is vital for a patients current health indication.

It would be wrong for the FDA to allow the company to shift a part of the data set to correct the time error. The SAFEST way to correct the dilemma would be to repeat the process entirely.

CON: Mistakes take time and money to fix
PRO: A second attempt showing consistent information gives merit to the companies agenda

disclaimer: this is only my interpretation of unfolding events for QRX. I am not a medical professional nor a scholar in FDA processes. Would love to have a fellow investor confirm my interpretation.