ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP) Files An 8-K Other Events
Item 8.01 Other Events
On December 16, 2016, Adamis Pharmaceuticals Corporation (Adamis
or the Company) issued a press release announcing that the
Company has resubmitted to the U.S. Food Drug Administration
(FDA) the Companys New Drug Application (NDA) to Section
505(b)(2) of the Food, Drug Cosmetic Act, as amended, for the
Companys Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single
Dose Syringe product candidate, for the emergency treatment of
anaphylaxis. The resubmission is intended to address the issues
raised by the FDA in the agencys June 2016 Complete Response
Letter (CRL).
A copy of the Companys press release relating to the resubmission
is filed as an exhibit to this Form 8-K.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements relate to future
events or our future results of operations, including, but not
limited to the following statements: the Companys beliefs
concerning the timing and outcome of the FDAs review of the
Companys NDA relating to its Epinephrine PFS product candidate
and the Companys ability to satisfactorily respond to the matters
raised in the FDAs Complete Response Letter relating to the
Epinephrine PFS product; the Company’s beliefs concerning the
ability of the Epinephrine PFS product or other product
candidates to compete successfully in the market; the Company’s
beliefs concerning the safety and effectiveness of its product
candidates; the results of any future clinical trials that the
Company may conduct relating to the Epinephrine PFS product or
the Companys other product candidates; the costs of any
additional studies or resubmissions to the FDA; the ability to
fund future product development; future revenues expected from
any of its product candidates, assuming that they are developed
and approved for marketing by the FDA and other regulatory
authorities; and the intellectual property protection that may be
afforded by any patents or patent applications relating to its
products and product candidates. Statements in this Report
concerning future events depend on several factors beyond the
company’s control, including receipt of adequate funding to
support these activities, the absence of unexpected developments
or delays, market conditions, and the regulatory approval
process. These statements are only predictions and involve known
and unknown risks, uncertainties and other factors, which may
cause the Companys actual results to be materially different from
these forward-looking statements. There can be no assurances that
the Company will successfully complete development of the
Epinephrine PFS product candidate, that the FDA will approve the
NDA following resubmission of the NDA by the Company, or that the
product will be commercially successful if introduced. The
Company will require additional funding to commercially launch
the product. Certain of these risks, uncertainties, and other
factors are described in greater detail in the Companys filings
from time to time with the SEC, which the Company strongly urges
you to read and consider, all of which are available free of
charge on the SEC’s web site athttp://www.sec.gov. Except to the
extent required by law, the Company expressly disclaims any
obligation to update any forward-looking statements.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1Press release dated December 16, 2016.
About ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP)