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BRIEF-CEL-SCI submits FDA response for its phase 3 head and neck cancer trial
June 5, 2017 / 12:26 PM / 6 months ago

BRIEF-CEL-SCI submits FDA response for its phase 3 head and neck cancer trial

June 5 (Reuters) - CEL-SCI Corp

* Cel-SCI submits FDA response for its phase 3 head and neck cancer trial

* CEL-SCI Corp - 928 patients have been enrolled, treated, and are now being followed for study’s primary endpoint

* CEL-SCI - hold issues addressed in FDA communication were that study’s investigator brochure (IB) and “dear investigator” letter need to be revised

* CEL-SCI Corp - specific deficiencies and their locations in each of documents were identified by FDA as hold issues

* CEL-SCI Corp - determination if study end point is met will occur when there are total of 298 deaths in two main comparator groups Source text for Eikon: Further company coverage:

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