Scilex Holding Company Announces Positive Type C Meeting With The FDA And Reaches Agreement On Path Forward To File An NDA For SP-102 In Lumbosacral Radicular Pain
Portfolio Pulse from Benzinga Newsdesk
Scilex Holding Company (NASDAQ:SCLX) has announced a positive Type C meeting with the U.S. Food and Drug Administration (FDA), reaching an agreement on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (NDA). Scilex plans to commence an open-label multi-center safety and efficacy trial in the first half of 2024, with completion of enrollment projected to occur in 2025. If approved, SP-102 would be the first corticosteroid with an indication for epidural administration in the U.S.
November 02, 2023 | 1:10 pm
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Scilex Holding Company's positive meeting with the FDA and the agreement on the path forward for SP-102 could potentially boost the company's stock in the short term. The approval of SP-102 would be a significant milestone for the company as it would be the first corticosteroid with an indication for epidural administration in the U.S.
The positive meeting with the FDA and the agreement on the path forward for SP-102 is a significant development for Scilex. This news could potentially attract investors and boost the company's stock in the short term. The approval of SP-102 would be a major milestone for the company, potentially leading to increased revenues and further boosting the stock.
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IMPORTANCE 80
RELEVANCE 100