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2 个月内
BRIEF-CEL-SCI receives letter from U.S. FDA
2017年6月29日 / 晚上9点18分 / 2 个月内

BRIEF-CEL-SCI receives letter from U.S. FDA

2 分钟阅读

June 29 (Reuters) - CEL-SCI Corp:

* Says on June 28, received a letter from U.S. FDA in response to most recent June 2 submission - SEC filing

* CEL-SCI Corp - in letter, FDA requested that three additional changes be made to multikine investigator brochure that co submitted to FDA on June 2

* Says FDA provided instructions directing CEL-SCI on what specific changes should be

* CEL-SCI Corp says intends to swiftly make requested changes to ib and submit its response to FDA as soon as possible after July 4 holiday

* Letter is regarding clinical hold imposed on co's phase 3 head and neck cancer study with multikine investigational new drug

* Says FDA did not raise any other hold issues in the recent letter

* Says was also told by FDA that effect of hold is not a termination of study

* CEL-SCI Corp - CEL-SCI may not enroll new patients and may not resume multikine dosing in any previously enrolled patient in the phase 3 study

* CEL-SCI may not initiate any new studies under the multikine investigational new drug Source text: (bit.ly/2sm4Ajl) Further company coverage:

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