Friday, September 04, 2020 11:50:12 AM
The base case for FDA guidance (99% probability, in my opinion) is that they will require a study. If they don’t, consider it an unexpected gift. You’re setting yourself and others up for unnecessary disappointment when you imply that anything other than no trial is bad. The good news is that according to prior statements, a study should be relatively fast and we do not need to raise money to conduct it.
Good luck!
Recent CTSO News
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/26/2024 09:14:03 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/26/2024 09:11:21 PM
- CytoSorbents to Present at the Inaugural American Association of Physicians of Indian Origin (AAPI) World Health Congress • GlobeNewswire Inc. • 07/17/2024 11:00:00 AM
- CytoSorbents Secures $20 Million Credit Facility • GlobeNewswire Inc. • 07/02/2024 11:00:00 AM
- CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan • GlobeNewswire Inc. • 06/24/2024 11:00:00 AM
- CytoSorbents Announces the Launch and Immediate Availability of the PuriFi™ Blood Pump in the European Union • GlobeNewswire Inc. • 06/13/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2024 08:31:20 PM
- CytoSorbents to Host its 2024 Virtual Annual Stockholders Meeting • GlobeNewswire Inc. • 06/05/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2024 08:35:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 09:23:00 PM
- CytoSorbents Reports First Quarter 2024 Results • GlobeNewswire Inc. • 05/09/2024 08:17:23 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:14:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:00:30 PM
- CytoSorbents May 6, 2024 Virtual KOL and Analyst-Investor Day: STAR-T Pivotal Trial Topline Results & Real World Experience with Antithrombotic Drug Removal in Europe • GlobeNewswire Inc. • 05/02/2024 11:00:00 AM
- CytoSorbents to Report First Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 04/26/2024 11:00:00 AM
- STAR-T Pivotal Trial Results to Be Featured as a Late-Breaking Presentation at the 2024 American Association for Thoracic Surgery Annual Meeting • GlobeNewswire Inc. • 04/17/2024 11:00:00 AM
- CytoSorbents to Report Fiscal 2023 Operating and Financial Results • GlobeNewswire Inc. • 03/06/2024 12:00:00 PM
- CytoSorbents to Present at the TD Cowen 44th Annual Health Care Conference • GlobeNewswire Inc. • 02/08/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/17/2024 10:20:45 PM
- Groundbreaking Randomized Controlled Trial Reports Excellent Clinical Outcomes Using CytoSorb® Intraoperatively in Heart Transplant Patients • GlobeNewswire Inc. • 01/17/2024 12:15:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 01/08/2024 08:00:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:49:02 PM
- CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation • GlobeNewswire Inc. • 12/28/2023 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/15/2023 09:35:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/15/2023 09:34:16 PM
Glidelogic Corp. Announces Revolutionary AI-Generated Content Copyright Protection Solution • GDLG • Jul 26, 2024 12:30 PM
Southern Silver Files NI43-101 Technical Report for its Updated Preliminary Economic Assessment for the Cerro Las Minitas Project • SSV • Jul 25, 2024 8:00 AM
Greenlite Ventures Completes Agreement with No Limit Technology • GRNL • Jul 19, 2024 10:00 AM
VAYK Expects Revenue from First Airbnb Property Starting from August • VAYK • Jul 18, 2024 9:00 AM
North Bay Resources Acquires Mt. Vernon Gold Mine, Sierra County, California, with Assays up to 4.8 oz. Au per Ton • NBRI • Jul 18, 2024 9:00 AM
Nightfood Holdings Signs Letter of Intent for All-Stock Acquisition of CarryOutSupplies.com • NGTF • Jul 17, 2024 1:00 PM