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TG Therapeutics Provides Update on FDA Meeting for GENUINE Phase 3 Trial

TG THERAPEUTICS (TGTX)  More Company Research Source: GlobeNewswire
Last tg therapeutics earnings: 8/7 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.tgtherapeutics.com
PDF NEW YORK, Oct. 16, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics (NASDAQ:TGTX) announced today that it has met with the U.S. Food and Drug Administration (FDA) regarding the use of the results from the GENUINE Phase 3 trial to support a Biologics License Application (BLA) filing for approval of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib.  During the meeting, the FDA confirmed that accelerated approval based on Overall Response Rate (ORR) would be a review issue.  As part of the discussion, the FDA encouraged the Company to consider future available therapy in its risk/benefit analysis as part of any potential future BLA filing that may impact accelerated approval. The Company and the FDA also discussed the potential use of Progression Free Survival (PFS) results from the GENUINE trial to support the full approval of TG-1101.  The Company plans to have a follow-up meeting with the FDA to discuss the use of the P [Read more]

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