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BRIEF-TG Therapeutics ‍says FDA confirms accelerated approval for TG-1101 based on overall response rate a review issue
October 16, 2017 / 2:51 PM / 2 months ago

BRIEF-TG Therapeutics ‍says FDA confirms accelerated approval for TG-1101 based on overall response rate a review issue

Oct 16 (Reuters) - TG Therapeutics Inc:

* TG Therapeutics provides update on fda meeting for genuine phase 3 trial

* TG Therapeutics - co ‍has met with U.S. FDA regarding use of results from genuine phase 3 trial to support bla filing for approval of TG-1101​

* TG Therapeutics Inc - ‍fda confirmed that accelerated approval for TG-1101 based on overall response rate would be a review issue ​

* TG Therapeutics - ‍FDA asked co to consider future available therapy in risk/benefit analysis in future BLA filing that may impact accelerated approval

* TG Therapeutics - co, FDA also discussed potential use of progression free survival results from genuine trial to support full approval of TG-1101​

* TG Therapeutics Inc - ‍plans to have a follow-up meeting with FDA to discuss use of PFs endpoint in more detail before end of year​ Source text for Eikon: Further company coverage:

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