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ADMP > SEC Filings for ADMP > Form 8-K on 23-Dec-2016All Recent SEC Filings




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 Company's New Drug Application ("NDA") pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for the Company's 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 agency's June 2016 Complete Response Letter ("CRL").

A copy of the Company's 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 Company's beliefs concerning the timing and outcome of the FDA's review of the Company's NDA relating to its Epinephrine PFS product candidate and the Company's ability to satisfactorily respond to the matters raised in the FDA's 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 Company's 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 Company's 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 Company's 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 at Except to the extent required by law, the Company expressly disclaims any obligation to update any forward-looking statements.

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