Tuesday, September 27, 2016 7:33:39 AM
My guess - CVM didn't follow correct procedures to make the FDA happy - and the FDA has 'dinged' them to get a chance to review what data there is and to get a specific set of explanations as to what CVM is attempting to do here.
It is worth it to note that the FDA didn't stop the trial outright, and is allowing enrolled patients to continue treatments and follow-up assessment.
Also is interesting IMO to note that the announcement indicates ~926 patients currently in the study population,.... so enrollment isn't slowing down post hitting '880'.
The share prices are undoubtedly going to take a hit today though,... it looks worse than it is but it does look bad.
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
Recent CVM News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 01:04:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 05:07:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 01:19:04 PM
- CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer • Business Wire • 05/08/2024 01:00:00 PM
- CEL-SCI Appoints Mario Gobbo to Its Board of Directors • Business Wire • 04/23/2024 01:00:00 PM
- CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology • Business Wire • 03/19/2024 01:00:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 03/07/2024 04:33:42 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 04:33:13 PM
- CEL-SCI Corporation Issues Letter to Shareholders • Business Wire • 03/06/2024 01:45:00 PM
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:31:12 PM
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- CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/09/2024 01:30:00 PM
- CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head & Neck Cancer Drug • Business Wire • 02/06/2024 02:00:00 PM
- European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine® • Business Wire • 01/31/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:06:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:03:28 PM
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- CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments • Business Wire • 12/22/2023 01:00:00 PM
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- UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer • Business Wire • 12/04/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2023 10:25:18 PM
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