Item 8.01 Other Events. Tecfidera CHMP Update
On
The CHMP Opinion states:
The CHMP, having considered the matter as set out in the appended ad hoc assessment report, is of the opinion that taking into account the described results, including the severe methodological limitations of the clinical studies, it cannot be concluded based on these data that a clinically relevant therapeutic effect of MEF in Fumaderm has been demonstrated.
Therefore, the CHMP concludes that the totality of the available data cannot establish that MEF exerts a clinically relevant therapeutic contribution within Fumaderm.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits The exhibits listed below are furnished as part of this Current Report on Form 8-K Exhibit Number Description 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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