Reuters logo
BRIEF-CEL-SCI receives letter from U.S. FDA
June 29, 2017 / 9:15 PM / 5 months ago

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

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: ( Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below