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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): March 1, 2017
CEL-SCI CORPORATION
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(Exact name of Registrant as specified in its charter)
Colorado 01-11889 84-0916344
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(State or other jurisdiction (Commission File No.) (IRS Employer
of incorporation) Identification No.)
8229 Boone Boulevard, Suite 802
Vienna, Virginia 22182
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(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (703) 506-9460
N/A
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(Former name or former address if changed since last report)
Check appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below)
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-14(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events
CEL-SCI announced that it has received the official minutes from its
February 8, 2017 meeting with the U.S. Food and Drug Administration (FDA) in
regards to the partial clinical hold placed on CEL-SCI's Phase 3 head and neck
cancer study. Pursuant to the partial clinical hold, patients currently
receiving study treatments can continue to receive treatment at the discretion
of their physicians and with their consent, and patients already enrolled in the
study will continue to be followed. As of March 6, 2017, 928 patients were
enrolled in this study.
The purpose of the February 8, 2017 meeting with the FDA was to discuss the
issues raised by the FDA with respect to the partial clinical hold and to obtain
the FDA's input and clarification on how to address these issues.
The Action Items for CEL-SCI to pursue per the minutes from the FDA are the
following:
1) Provide an updated Investigator's Brochure and current procedures for
compliance with requirements under 21 CFR 312 Subpart D to address the
partial clinical hold.
2) Provide a list of major protocol deviations, which CEL-SCI believes
will affect study results, and provide a plan to identify major
protocol deviations across all patients enrolled in the Phase 3
protocol.
CEL-SCI is working diligently on responding to all Action Items.
It is CEL_SCI's belief that addressing the Action Items listed above will
support a favorable decision by the FDA to lift the partial clinical hold. While
CEL-SCI believes that it understands the Action Items, it is possible that
CEL-SCI has not understood all issues involved. All of CEL-SCI's work is subject
to the FDA's review of CEL-SCI's submission upon its completion and may or may
not result in the lifting of the partial clinical hold.
Item 9.01 Financial Statements and Exhibits
On March 6, 2017 CEL-SCI issued a press release, attached as Exhibit 99,
concerning the receipt of the FDA's minutes of the February 8, 2017 meeting.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: March 6, 2017
CEL-SCI CORPORATION
By: /s/ Patricia B. Prichep
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Patricia B. Prichep
Senior Vice President of Operations
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