TG Therapeutics (TGTX) Files Amended Protocol for GENUINE Phase 3 Trial; Revises Primary Endpoint
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TG Therapeutics, Inc. Amends the GENUINE Phase 3 Clinical Trial to Accelerate Study Completion by Revising Primary Endpoint to Overall Response Rate
October 13, 2016 7:00 AM EDTFDA agrees that Overall Response Rate (ORR) data from revised GENUINE study can be used to request pre-BLA (Biologics License Application) meeting
If results of the revised GENUINE study are positive, the Company plans to file a BLA for accelerated approval based on the outcome of the pre-BLA meeting
Enrollment expected to be completed before year end 2016 with top-line data available in first half of 2017
Amendments expected to save the Company more than $10 million over the next 2 years, and allow the Company to focus its resources on the UNITY-CLL program
... MoreTG Therapeutics, Inc. to Host Conference Call to Provide an Update on the GENUINE Phase 3 Trial
October 12, 2016 4:30 PM EDTNEW YORK, Oct. 12, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held tomorrow, Thursday, October 13, 2016 at 8:30am ETÂ to provide an update on the GENUINE Phase 3 Trial. Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer, will host the call.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),... More
