Praxis Precision Medicines, Inc.
CRL AI-extracted
relutrigine
SCN2A and SCN8A developmental and epileptic encephalopathies
Date
TBD
FDA decision · Date TBD estimated
What's at stake An FDA complete response letter on relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies is in focus around Date TBD.
“Assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.”

Provenance

1 source on file.

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