Item 8.01 Other Events
On December 1, 2020, Adamis Pharmaceuticals Corporation ("Adamis" or the
"Company") issued a press release announcing the Company's planned response to
the Complete Response Letter ("CRL") that the Company received in November 13,
2020, from the U.S. Food & Drug Administration ("FDA") regarding the Company's
resubmitted New Drug Application ("NDA") for its ZIMHI™ high-dose naloxone
injection product for the treatment of opioid overdose.
A copy of the Company's press release is attached hereto as Exhibit 99.1 and is
incorporated into this item by reference.
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. Such
forward-looking statements include those that express plans, anticipation,
intent, contingencies, goals, targets or future development and/or otherwise are
not statements of historical fact. These statements relate to future events or
future results of operations, including, but not limited to the following
statements: the company's beliefs concerning its ability to satisfactorily
respond to the matters raised in the FDA's CRL; the company's beliefs concerning
the information, data and actions that the FDA may require in connection with
any resubmitted NDA relating to ZIMHI; the company's beliefs concerning the
timing and outcome of any appeal and FDA formal dispute resolution process that
the company may initiate; the company's beliefs concerning the results of any
future studies or clinical trials that the company may conduct relating to
ZIMHI; the company's beliefs concerning the timing and outcome of the FDA's
review of the company's NDA relating to the ZIMHI product or any resubmitted
NDA; the company's beliefs concerning its ability to commercialize ZIMHI and its
other products and product candidates; the company's beliefs concerning the
ability of its product candidates to compete successfully in the market; the
company's beliefs concerning the safety and effectiveness of ZIMHI or its other
products and product candidates; the company's beliefs concerning its
commercialization strategies; and the company's beliefs concerning the
anticipated timing of any commercial launch of its ZIMHI product. These
statements are only predictions and involve known and unknown risks,
uncertainties and other factors, which may cause Adamis' actual results to be
materially different from these forward-looking statements. The FDA may require
additional studies or other actions, data or information, prior to any
resubmission of the NDA. There can be no assurances that the company will be
able to satisfactorily respond to the matters raised in the FDA's CRL or
concerning the timing of any resubmission by us of the NDA responding to the
CRL, concerning the timing or costs of any additional actions that may be
required in connection with any resubmission of the NDA, that the FDA will
approve any resubmitted NDA relating to our ZIMHI product or concerning the
timing of any future action by the FDA on our NDA, that the company will be
successful in any formal dispute resolution appeal process with the FDA, or that
the product will be able to compete successfully in the market if approved and
launched. In addition, forward-looking statements concerning our anticipated
future activities assume that we are able to obtain sufficient funding to
support such activities and continue our operations and planned activities. As
discussed in our filings with the Securities and Exchange Commission, we will
require additional funding, and there are no assurances that such funding will
be available if required. You should not place undue reliance on any
forward-looking statements. Further, any forward-looking statement speaks only
as of the date on which it is made, and except as may be required by applicable
law, we undertake no obligation to update or release publicly the results of any
revisions to these forward-looking statements or to reflect events or
circumstances arising after the date of this Report. Certain of these risks,
uncertainties, and other factors are described in greater detail in Adamis'
filings from time to time with the SEC, which Adamis strongly urges you to read
and consider, all of which are available free of charge on the SEC's web site
at http://www.sec.gov. Except to the extent required by law, any forward-looking
statements in this Report speak only as the date of this Report, and Adamis
expressly disclaims any obligation to update any forward-looking statements.
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