Current Report Filing (8-k)
December 26 2019 - 5:00PM
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): December 19, 2019
ADAMIS
PHARMACEUTICALS CORPORATION
(Exact
Name of Registrant as Specified in Charter)
Delaware
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0-26372
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82-0429727
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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11682
El Camino Real, Suite 300
San
Diego, CA
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92130
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (858) 997-2400
(Former
name or Former Address, if Changed Since Last Report.)
Check
the 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):
☐
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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 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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Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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. ☐
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on
which registered
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Common
Stock
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ADMP
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NASDAQ
Capital Market
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On
December 19, 2019, Adamis Pharmaceuticals Corporation (the “Company”) issued a press release providing
an update on the ZIMHI™ New Drug Application (“NDA”) resubmission process.
On November
22, 2019, the Company received a Complete Response Letter (“CRL”) from the U.S.
Food and Drug Administration (“FDA”)
regarding its NDA for its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The Company
has provided responses to the comments included in the CRL and submitted these answers to the FDA.
With the responses, the Company requested a Type A meeting with the FDA and is currently waiting for the FDA to
respond to this request. The next update from the Company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting
occurs. At that time, the Company would expect to have more information regarding the timeline for the full resubmission of the
NDA back to the FDA.
A
copy of the Company’s press release is attached hereto as exhibit 99.1 and incorporated herein by reference.
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Item
9.01
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Financial Statements and Exhibits
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(d)
Exhibits.
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99.1
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Press
release dated December 19, 2019.
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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.
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ADAMIS PHARMACEUTICALS CORPORATION
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Dated: December
26, 2019
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By:
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/s/
Robert O. Hopkins
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Name:
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Robert O. Hopkins
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Title:
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Chief Financial
Officer
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