Friday, March 17, 2017 10:42:43 AM
Also, they reduced the number of patients from 200 to 120. Their PR said the FDA has agreed that Overall Response Rate (ORR) data from the revised GENUINE study can be used to request a pre-BLA (Biologics License Application) meeting. Using this data to request a pre-BLA meeting is a far cry from the FDA approving a modified SPA. This meeting has not even taken place yet, and there is no guarantee the ORR data with fewer patients will be accepted as adequate for a possible approval.
If you can show me where the FDA agreed to amend the SPA to accept ORR and fewer patients after TGTX made these modifications, I'd like to see that.
Recent TGTX News
- New BRIUMVI® (ublituximab-xiiy) Data from the ENHANCE Phase 3b Study Show Rapid 30-Minute Infusions are Well Tolerated in Patients with Relapsing Forms of Multiple Sclerosis • GlobeNewswire Inc. • 09/18/2024 11:15:00 AM
- New Data for BRIUMVI® (ublituximab-xiiy) Demonstrate that 92% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 5 Years of Treatment • GlobeNewswire Inc. • 09/18/2024 11:00:00 AM
- Palantir Technologies, Dell Technologies, and Erie Indemnity Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600 • PR Newswire (US) • 09/06/2024 10:43:00 PM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI at the 2024 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting • GlobeNewswire Inc. • 09/05/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 08:03:55 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 08/09/2024 08:01:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:08:39 AM
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance • GlobeNewswire Inc. • 08/06/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on Second Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 08/05/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 08:48:08 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 07:08:53 PM
- Form PX14A6G - Notice of exempt solicitation submitted by non-management • Edgar (US Regulatory) • 06/10/2024 03:23:35 PM
- TG Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference • GlobeNewswire Inc. • 06/07/2024 11:50:00 AM
- TG Therapeutics to Participate in the Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 06/03/2024 11:30:00 AM
- TG Therapeutics Announces Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/31/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Upcoming Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/28/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/06/2024 08:59:11 PM
- TG Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on First Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 04/30/2024 08:55:29 PM
- TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/18/2024 11:30:00 AM
- TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis • GlobeNewswire Inc. • 04/18/2024 11:00:00 AM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/15/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 03/08/2024 12:30:00 PM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum • GlobeNewswire Inc. • 03/01/2024 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 10:23:27 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM