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Dr Frederic Sedel, co-founder and CEO of Medday said: “The decision to withdraw the application was based on the understanding that the EMA was not ready to approve high dose biotin for the treatment of progressive MS based on a single –relatively small- phase III study. This decision means that we will present a much stronger case in the future, based on the results of the ongoing SPI2 study, which is a much larger trial. The SPI2 trial is still looking at patients’ improvement together with decreased progression which is a very ambitious goal. It will also give more information about the subgroups of patients who will benefit the most from the drug, about brain imaging and other measures of efficacy.”