FDA extends relutrigine review by three months to December 27

Regulation
โดย Seeking Alpha·Read original
Summary · why it matters

The US FDA has extended the review period for Praxis Precision Medicines' application for relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies by three months to December 27. The extension follows the company's submission of additional sensitivity analyses of existing data, which the agency considers a major amendment. No new studies are requested, and no safety or manufacturing issues were mentioned.

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