Hello again, Scott, I see what you mean. Based on the information on Pluristem’s website and articles in the press I had the impression that enrolement for Phase III (CLI) started a while ago and that it is expected that all the patients being part of this trial will be enrolled by the end of 2017.
I have a question for you and the rest of the board. Let’s just say for argument’s sake that enrolement started in July 2017 and by September half of the patient group had been enrolled, would treatment have started as soon as patients had been enrolled? Would this group then form the 50% of the study needed to apply for fast track approval or would it be necessary to wait until every patient has been enrolled for things to proceed? I may be talking complete nonsense here, but I am not clear about that.
This is information directly quoted from Pluristem’s website:
‘Pluristem Advances its Multinational Phase III Critical Limb Ischemia Study, Targeting Initiation at 40 Active Sites by the End of 2017
• Austria’s regulatory health agency clears CLI study and joins the U.S., U.K., and Germany in conducting the 250-patient Phase III trial
HAIFA, ISRAEL, July 10, 2017— Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Austria’s regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), has cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI). The trial is currently enrolling patients in the U.S., U.K., and Germany. ‘
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