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Re: Stockfun1 post# 2535

Monday, 07/20/2020 10:36:28 AM

Monday, July 20, 2020 10:36:28 AM

Post# of 2676
Stockfun this is the point to focus on...

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...........
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