Medday withdraws licencing application for high dose Biotin

Biotin is an emerging therapy for the treatment of secondary progressive MS.
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MSUK
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Medday withdraws licencing application for high dose Biotin

Post by MSUK » Wed Dec 20, 2017 2:22 am

Medday withdraws licencing application for high dose Biotin for progressive MSers

Medday, the makers of Biotin have formally withdrawn their application for EMA (European Medicines Agency) marketing authorisation for progressive MS drug Qizenday...

Read more - http://www.ms-uk.org/medday-withdraws-l ... sive-msers

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NHE
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Re: Medday withdraws licencing application for high dose Bio

Post by NHE » Wed Dec 20, 2017 3:05 am

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.”

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jimmylegs
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Re: Medday withdraws licencing application for high dose Bio

Post by jimmylegs » Wed Dec 20, 2017 5:56 am

take control of your own health
pursue optimal self care at least as actively as a diagnosis
ask for referrals to preventive health care specialists eg dietitians
don't let suboptimal self care muddy any underlying diagnostic picture!

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