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Friday, August 08, 2014 2:13:20 PM
An excerpt for the thread:
CEL-SCI's change in contract research organizations ((CRO)) is resulting in faster enrollment: the company announced last month total patient enrollment of 232 people, more than one-quarter towards their goal of 880 by the end of next year. Critics complain that CEL-SCI cannot meet its target, but do not take into consideration acceleration of enrollment made possible by the number of countries and organizations for which trials have been and continue to be approved, with multiple sites available in each. In the past three months alone, Turkey, Austria, Sri Lanka, France and the UK have come on board, totaling 17 countries in all. This is truly a global trial - sites also include those in Canada, India, Israel, Poland, Hungary, Russia, Taiwan, Ukraine, Serbia, Croatia, and Bosnia and Herzegovina.
In the US, CEL-SCI gained approval from Detroit's Henry Ford Health System, one of the nation's largest group practices with over 1,200 doctors in 40 specialties. This followed 21st Century Oncology of Greenville, North Carolina, with 166 treatment centers in 16 states and six Latin American countries. My question is why would management, by keeping a running count of enrollees, hold itself up to public embarrassment and investor scorn if it did not fully expect to reach its desired enrollee numbers?
No doubt, CEL-SCI has a long road ahead, and a pivotal trial of this magnitude may quickly burn through its remaining cash, forcing it to seek dilutive financing. Its own clinical and regulatory risks notwithstanding, CEL-SCI faces upcoming competition from AstraZeneca, Merck and Bristol-Myers who plan studies in head and neck cancer, big firms with deep pockets. The I-O arena is also drawing critics: oncologists have gone on record urging caution concerning the results being churned out by Big Pharma, siting small sample sizes, lack of control groups, efficacy in only a minority of cancer patients, and bad side effects. Particularly when using two I-Os in combination for best results, a trend seen recently.
Regardless of risks, CEL-SCI is well-positioned to enter the I-O race. Head and neck cancer, including disease of the larynx, thyroid, salivary glands and nasal passages account for up to 5% of all cancers in the US,and cause 12,000 deaths per year, for a total market of slightly over $3 billion. Because of its prominent, visible position on the body, better agents are needed to reduce the size of tumors and limit the amount of disfiguring surgery. CEL-SCI is ahead of Big Pharma in filling this medical need, and given its undervalued status compared to competitors large and small presents a golden opportunity to take advantage of the budding I-O industry.
Recent CVM News
- CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population • Business Wire • 06/18/2024 12:00:00 PM
- Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor • Business Wire • 06/06/2024 11:00:00 AM
- CEL-SCI Corporation Reports Second Quarter Fiscal 2024 Financial Results • Business Wire • 05/16/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:17:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 01:04:18 PM
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- 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
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- 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
- CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results • Business Wire • 02/15/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:31:12 PM
- CEL-SCI Announces Closing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/13/2024 05:00:00 PM
- 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
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:00:11 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 12/22/2023 09:01:06 PM
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