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ARTICLE | Clinical News

Cel-Sci submits response regarding FDA's hold on Phase III trial of Multikine

June 23, 2017 7:38 PM UTC

Cel-Sci Corp. (NYSE-M:CVM) said it responded to a May communication from FDA regarding a partial clinical hold the agency placed in September 2016 on a Phase III trial of Multikine leukocyte interleukin injection to treat squamous cell carcinoma of the head and neck (SCCHN). FDA placed the hold after it identified issues in trial documents related to investigator conduct and reporting.

In a May letter to shareholders, the company said FDA rejected proposed revisions of the texts the company had proposed in April, and that the agency also identified new deficiencies. The partial hold was switched to a full clinical hold at the time. Cel-Sci also told shareholders it was working to win an arbitration case against its former CRO originally running the trial...

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