Pluristem Therapeutics Inc (PSTI)

[zzaatt]

Nah, 4.5 years to get to Phase III is far too long.

Very disingenuous !!!!!!!! P3's are ongoing!


Two pivotal, Phase III multinational clinical trials are currently being conducted with our PLX-PAD product candidate: one in CLI, and the other in recovery following surgery for hip fracture.

Pluristem Initiates Two Pivotal Phase III Studies in Israel
HAIFA, Israel, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that Israel’s Ministry of Health has cleared the Company to commence patient recruitment in Israel for two ongoing pivotal Phase III trials of PLX-PAD cell therapy, one for the treatment of Critical Limb Ischemia (CLI) and another for the treatment of muscle injury following hip fracture surgery. Both trials have been accepted to accelerated approval pathways and have received a total of $16.7 million in grants from the European Union’s Horizon 2020 Program. “We are pleased to open clinical sites in Israel for both of our ongoing pivotal Phase III studies.

The Phase III CLI study was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).

Regulators are eager for an innovative new therapy to address this severe unmet need and have selected PLX-PAD for rapid regulatory pathways in the U.S., Europe and Japan. The U.S. FDA has also approved the use of PLX-PAD in CLI through its Expanded Access Program, for patients who do not qualify for Pluristem’s Phase III CLI study. When 12 months of data are available on the first 50% of patients in this trial, European regulators may allow for interim results to be evaluated in support of early conditional marketing approval under the EMA’s Conditional Marketing Authorization program.