The FDA stated that the data were not presented in usable form because Amarex failed in some of the most basic tasks of data collection. For instance, they did not state the date(s) of administration of Leronlimab for some patients. Also, they filled the forms out incorrectly, despite the clear guidance of the FDA after the first failed submission. The 2nd submission left many of those initial errors uncorrected, and added new errors such as moving data from the previous filing which had been in the correct section of the form into an incorrect area.

The independent auditors said that the data could not be used.

I find it difficult to believe that this was mere incompetence.