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  • FDA Asked for Newest risdiplam Data to Support Broad Label – Roche Says

    Posted by michael-morale on April 16, 2020 at 12:20 pm

    https://www.youtube.com/watch?v=iccgTiB1LZI&feature=youtu.be

     

    Hey everyone! Hope you’re all staying safe and healthy out there.

    In this episode of the Morale Monologue, I discuss a recent decision by the FDA regarding Roche/Genentech’s experimental SMA therapy risdiplam. Recently, Roche/Genentech submitted additional data to the FDA to include older patients. This data also includes patients’ ability to receive this treatment, if and when the FDA approves it. I include information regarding why the FDA has decided to push the decision regarding risdiplam to August. I also talk about why I think this was a good decision by both Roche/Genentech, and the FDA.

     

    NOTE:  In my video, I state that I’m linking an article that was written by SMA News Today regarding this topic. However, there are two articles. Please read both articles and share them with your family and friends, and also your doctors.

     

     

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    First article

    Second article

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    michael-morale replied 4 years, 8 months ago 1 Member · 0 Replies
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