Item 8.01 Other Events
On November 16, 2020, Adamis Pharmaceuticals Corporation ("Adamis" or the
"Company") issued a press release announcing that after the close of U.S.
markets on November 13, 2020, it received a Complete Response Letter ("CRL")
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 CRL is issued by the
FDA's Center for Drug Evaluation and Research when it has completed its review
of a file and questions remain that preclude the approval of the NDA in its
current form. The CRL stated that the FDA determined that it cannot approve the
Company's NDA in its present form and provided recommendations needed for
resubmission. The questions raised by the FDA related generally to new
Chemistry, Manufacturing and Controls (CMC) issues. The Company is reviewing the
CRL, plans to provide the FDA with additional analysis and information in order
to attempt to satisfy the CRL items, and intends to request a Type A meeting or
consider other options to resolve the issues.
A copy of the Company's press release is attached hereto as Exhibit 99.1 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
results of any future studies or clinical trials that the company may conduct
relating to ZIMHI or its other products or product candidates; 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; 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, and/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, 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 press release. 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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