NeuroPace says FDA deems epilepsy label expansion filing not approvable in current form
NPCE•Company plans amendment discussion
NeuroPace said it plans to file a Submission Issue Request to align on an amendment strategy, signaling a likely delay to any label expansion decision.
FDA flags NeuroPace epilepsy label expansion filing
NeuroPace said the FDA told it its PMA panel-track supplement to expand RNS into drug-resistant idiopathic generalized epilepsy is not approvable as filed.
The agency requested additional clinical evidence from the NAUTILUS trial, including more data and context on patient populations, plus supporting literature.
