Re: Farmas USA
ATHX
MultiStem® cell therapy product (the “MASTERS-2” study) has received a Final Scientific Advice positive opinion from the European Medicines Agency (“EMA”). This represents EMA’s opinion that, upon success, the study should be sufficient to warrant approval for commercialization, which is in line with the U.S. Special Protocol Assessment and Fast Track Designation. In Japan, Athersys’ partner, HEALIOS K.K. (“Healios”) is conducting the TREASURE study, evaluating MultiStem therapy for ischemic stroke, and has received a priority review designation under Sakigake from Japan’s Pharmaceutical and Medical Devices Agency. The results from the TREASURE study, if needed, are acceptable for supporting the applications for registration, along with the results from the MASTERS-2 study, in both the U.S. and Europe
https://finance.yahoo.com/news/athersys-reports-alignment-key-regulators-100000822.html
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