US Stem Cell Inc (USRM)

[cvinvestor]

Another extract from USRM's appeal:

p 10 under section III

The district court’s order is based on FDA’s interpretation that the word “HCT/P’s” in section 1271.15(b) means “HCT/P’s in their original form,” where the “original form” factor is derived from FDA’s guidance but is nowhere in the regulation itself. FDA contradicts the lower court’s order by arguing on appeal that the SSP Exception in unambiguous, yet FDA nowhere provides an argument based solely on the words of the regulation itself.