OS Therapies Inc., a clinical-stage biopharmaceutical company, announced an important regulatory update regarding their immunotherapy candidate OST-HER2. The company has submitted preliminary external control data and comprehensive plans to the US Food & Drug Administration (FDA) as part of their efforts to secure marketing authorization under the FDA's Accelerated Approval Program. This submission is in line with the prevailing guidance to industry, including ICH E10 and other FDA guidelines. The regulatory update follows recent positive clinical trial data showing statistically significant 1-year event-free survival for their Phase 2b trial in lung metastatic osteosarcoma. OS Therapies has also responded to follow-up questions from the FDA Type D Meeting, positioning them for an End of Phase 2 meeting, further advancing their regulatory review process.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。