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Monday, July 17, 2017 2:22:14 PM
Phase 3 - They said they're just about done with the last remaining site that'll be a part of the study. I forget exactly what was said but once the site is ready, they'll initiate enrollment for all hospitals and begin phase 3 trial. CEO said "very soon" when asked about a start date. No specific start date was given. (I suspect in the next few weeks). Also, they discussed the Phase 3 timeline and design. Total patients will be 200, 1:1 randomized placebo controlled, multi-dose treatment every 8 weeks. Patients will be treated 3 times during the phase 3 trial. Also, there's 6 sites that'll be participating in the trial. It's the same 3 hospitals as Phase 2 which are University of Massachusetts, Massachusetts General Hospital, and Mayo Clinic. Of the 3 new hospitals, two of them are in California (San Fran and Irvin I think) and the last hospital name was not given. They're still working out details with the hospital so no name was provided.
Hospital Exemption - Not approved yet in Israel. CEO said they're very close and still negotiating. He suspects by the end of the summer they'll have an answer and potentially start treatment by the end of the year (if approved).
Recent BCLI News
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