Monday, July 05, 2021 9:45:52 AM
I crawled out of my dark, social media hole because I think Multikine should get a fair shake. If a drug and a company fail because it is a bad drug I am pleased the process works to protect the patient. In Cel-Sci’s case I am most worried that a (likely) good drug could fail because the complexity and uniqueness of Multikine makes it easy for profiteering to damage the company and prevent it from crossing the finish line. These small drug companies are where our society has chosen to push the medical envelope, unfortunately our current SEC rules do not protect them.
An activated immune system by definition means that cells which have been selected as carrying antibodies or T-cells targeting the desired antigen (in this case cancer cells) can rapidly reproduce to generate an immune response. Chemo is designed to target rapidly reproducing cells and kill them. Any Immunology 410 student would expect chemo to destroy an immune response. If this were phrased as a question on a multiple choice Immunology 410 test the students would almost all answer C: The chemotherapy would adversely affect an immunological, anti-cancer response.
Unfortunately for Cel-Sci their hands were tied at the beginning because they could not ethically design a study without chemo. The decision for +/- chemo can be made at any point, pre-surgery, pre-radiation, post surgery, post radiation. The factors weighing in to this decision are many but include staging and tumor genetic risk factors and tumor morphology. Cel-Sci had zero control over this aspect of the decision-making process.
The FDA knows and understands the whole story. Fortunately for Cel-Sci as part of SOC there is a low risk subgroup which does not receive chemo because the risk of chemo toxicity outweighs its benefit in this subgroup. This subgroup then sent out a strong signal of efficacy that was statistical significant using the primary outcome measure the study was designed to capture.
Anyone who tells you with confidence that the FDA is going to spike this is lying to you or clueless.
People should definitely make their own decisions and know the facts because this remains a risky investment, but I do not believe it is a dumb investment like many want you to believe.
I will probably stop posting soon but thought I could leave you with the below interesting info:
https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.4550
Cliff notes: Cisplatin prematurely ages a testicular cancer patient 7.5 years.
Cheers
Recent CVM News
- CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation • Business Wire • 09/16/2024 11:30:00 AM
- CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress • Business Wire • 09/10/2024 01:32:00 PM
- The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance • Business Wire • 09/04/2024 01:00:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/30/2024 08:32:13 PM
- CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial Results • Business Wire • 08/15/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:27:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:16:11 PM
- CEL-SCI Announces Closing of $10.8 Million Offering • Business Wire • 07/29/2024 08:05:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/29/2024 11:00:58 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/26/2024 09:27:40 PM
- CEL-SCI Announces Pricing of $10.8 Million Offering • Business Wire • 07/26/2024 03:52:00 PM
- CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results • Business Wire • 07/26/2024 12:23:00 PM
- CEL-SCI Appoints Robert Watson as Chairperson of the Board • Business Wire • 07/08/2024 01:15:00 PM
- 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
- 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 ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 04:33:13 PM
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Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
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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