Pluristem Therapeutics Inc (PSTI)

[FDApproved]

For Those Who Never Do DD !

The Number Is Now 123 Not 125 ! Giddy-Up !


PLX-PAD cells have been selected by the European Medicines Agency (EMA) to be developed for CLI via the Adaptive Pathways pilot project. Under this regulatory pathway, the multinational
Phase III trial may potentially lead to early marketing approval of PLX-PAD for CLI in Europe, based on interim efficacy data from the first 125 patients that have completed a follow-up of 12
months. Data from the entire 250 patients will be submitted to the U.S. FDA for a Biologics License Application (BLA) targeting commercialization, and to the EMA to apply for full marketing approval.


http://www.pluristem.com/wp-content/uploads/2017/01/PEI_final_isa.pdf