Ann: Paradigm receives clarity on US regulatory pathway, page-2

...a clincher...."The FDA noted that the bene PPS was comprised of multiple moieties1 and those moieties and their levels were understood and acceptable to the US FDA. In contrast “PPS” from other manufacturers could have different levels of moieties and the safety and efficacy of those moieties were not well understood or controlled. A generic PPS could only be approved by the US FDA if the material was proven to be identical in molecular structure and purity to the bene PPS. Given PAR has an exclusive supply agreement in place with bene pharmaChem this puts PAR years ahead of any potential competition. This regulatory exclusivity is an additional level of its competitive advantage over and above Paradigm’s granted patents.".....one very upbeat holder here