CVM - CEL-SCI to soon address FDA concerns on cancer therapy

• Clinical-stage biotech CEL-SCI Corporation ( NYSE: CVM ) announced Wednesday that the company would respond to the FDA with a “major follow-up package” after the regulator raised questions and comments on its cancer immunotherapy Multikine.
• CVM has conducted a Phase 3 study for Multikine in the advanced primary head and neck cancer, a disease area that the company said, had no FDA-approved therapies in decades.
• Issuing a letter to investors on Wednesday, the company said that the FDA issued questions and comments about the therapy at a recent meeting.
• “This is normal,” CVM said, adding: “We believe FDA and other regulatory agencies will recognize these patients’ dire need for a treatment better than what is available today.”
• After releasing Phase 3 results for Multikine in primary squamous cell carcinoma of the head and neck in June, CVM said that it plans to submit a Biologic License Application with the FDA for the injection.

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