Stem Cell Trial Update: January 31, 2014

Friday, January 31, 2014

Tisch MS Research Center of New York submitted our FDA-approved protocol for review by an Institutional Review Board (IRB), an organization designated by the Department of Health and Human Services (HHS) to monitor and supervise research involving human subjects, whose approval is a regulatory requirement for moving forward with any clinical research trial. IRB review was completed during the week of January 26, 2014. The IRB deferred approval of our protocol pending several revisions to submitted documents. This decision does not in any way affect our previously-obtained FDA approval. Tisch MS has been and will continue to work with the IRB to resolve all outstanding discrepancies in our submission. We expect to reach a favorable conclusion in the near future, only after which will study activities commence. We appreciate the continued patience and support of our patients as we settle the final regulatory barriers to beginning this long-awaited clinical trial.

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