Monday, July 20, 2020 10:36:28 AM
A pre-planned ad hoc analysis of the most severely impacted patients in the trial, as defined by patients having at least 90% methylation (“full methylation”) of the impacted FMR1 gene, demonstrated that patients receiving Zygel achieved statistical significance in the primary endpoint of improvement at 12 weeks of treatment in the Social Avoidance subscale of the ABC-CFXS compared to placebo (p=0.020). This group comprised 80% of the patients enrolled in the CONNECT-FX study
If FDA comes back with an all clear for this group (FULL METHYLATION) for NDA.....................Lots of things change...........
Recent ZYNE News
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- Form SC 14D9/A - Solicitation, recommendation statements: [Amend] • Edgar (US Regulatory) • 10/04/2023 09:29:21 PM
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