Brief: Scilex Holding Company Announces Positive Type C Meeting With The FDA And Reaches Agreement

Scilex Holding

02/11/2023 13:05

Nov 2 (Reuters) - Scilex Holding Co  SCLX.O :
    * SCILEX HOLDING COMPANY ANNOUNCES POSITIVE TYPE C MEETING
WITH
THE FDA AND REACHES AGREEMENT ON PATH FORWARD TO FILE AN NDA FOR
SP-102 (SEMDEXATM) IN LUMBOSACRAL RADICULAR PAIN (SCIATICA)
    * SCILEX HOLDING CO: REACHED AGREEMENT WITH FDA ON PATH
FORWARD TO
ADVANCE CLINICAL DEVELOPMENT OF SP-10
    * SCILEX HOLDING CO: RECEIVED AN ADVISEMENT ON EXPECTATIONS
AND
REQUIREMENTS TO FILE NDA FOR SP-102
    * SCILEX HOLDING CO: INTENDS TO FILE SP-102 NDA UTILIZING
505(B)(2) REGULATORY PATHWAY
    * SCILEX HOLDING CO: PLANNING TO COMMENCE AN OPEN-LABEL
MULTI-CENTER SAFETY AND EFFICACY TRIAL IN FIRST HALF OF 2024

Source text for Eikon:  ID:nGNXtJ8rN 
Further company coverage:  SCLX.O 

 ((Reuters.Briefs@thomsonreuters.com;))