CEL-SCI Corporation recently had a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the approval of Multikine for head and neck cancer treatment. The FDA recognizes the urgent need for better therapies in this field and is willing to collaborate with CEL-SCI to demonstrate the effectiveness of Multikine as a potential treatment option. Additionally, CEL-SCI is actively seeking approval in other markets such as Europe, the United Kingdom, and Canada.
During the meeting, the FDA provided initial feedback suggesting that CEL-SCI's selection criteria could be utilized to determine which patients would benefit most from receiving Multikine. Taking this feedback into account, CEL-SCI is now preparing additional information for their upcoming meeting with the FDA.
Later this year, CEL-SCI expects to hold scientific advice meetings with regulatory agencies in Europe and the UK. These regions are particularly important to CEL-SCI due to their higher incidence rates of head and neck cancer compared to the United States.