CEL-SCI issues letter to shareholders regarding Multikine cancer therapy

CEL-SCI ssued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting: “Last year we successfully moved our investigational Multikine cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times …We solved this issue with great success and presented the selection criteria at a major oncology conference: CEL-SCI plans to seek approval for immediate patient access to Multikine without waiting on the results of a new trial wherever possible. There are regulatory pathways specifically designed for such approvals that CEL-SCI is pursuing worldwide. These pathways are called “conditional approvals” which means you can be approved first while a confirmatory study is ongoing and before that study is completed. Our situation-where we have selected a portion of the Phase 3 study for our target population-is precisely why these regulatory pathways were adopted by regulatory bodies, so that patients do not need to wait many years before gaining access to promising drugs that have already been shown to provide clinical benefit.