Current Report Filing (8-k)
July 21 2020 - 09:07AM
Edgar (US Regulatory)
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): July 17, 2020
Adial
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in charter)
Delaware
(State
or other jurisdiction of incorporation)
001-38323
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82-3074668
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(Commission
File Number)
|
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(IRS
Employer Identification No.)
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1180
Seminole Trail, Suite 495
Charlottesville,
Virginia 22901
(Address
of principal executive offices and zip code)
(434)
422-9800
(Registrant’s
telephone number including area code)
(Former
Name and Former Address)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under
any of the following provisions:
☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material
pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Trading
Symbols
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Name
of each exchange on which registered
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Common
Stock
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ADIL
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NASDAQ
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Warrants
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ADILW
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NASDAQ
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Indicate
by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17
CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
8.01. Other Events.
On
July 17, 2020, Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”), received notice that the European
Medicines Agency (EMA) has accepted the Pediatric Investigation Plan (PIP) submitted by the Company for development of the Company’s
lead drug candidate, AD04, for the treatment of alcohol use disorder in the pediatric population, ages 12 to 17. As part of the
regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining
their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for
filing a Marketing Authorization Application (MAA) for a new medicinal product in the European Union.
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.
Dated: July
21, 2020
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ADIAL
PHARMACEUTICALS, INC.
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By:
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/s/
William B. Stilley, III
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Name:
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William B. Stilley
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Title:
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President and Chief
Executive Officer
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2
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