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As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 12/26/19 Adamis Pharmaceuticals Corp 8-K:8,9 12/19/19 2:44K Quality EDGAR So… LLC/FA |
Document/Exhibit Description Pages Size 1: 8-K Current Report HTML 18K 2: EX-99.1 Press Release Dated December 19, 2019 HTML 13K
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 | 0-26372 | 82-0429727 | ||||
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) | ||||
11682 El Camino Real, Suite 300 |
92130 | |||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||
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):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 | Trading Symbol(s) | Name
of each exchange on which registered | ||
| Common Stock | ADMP | NASDAQ Capital Market |
C:
| Item 8.01 | Other Events |
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.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| 99.1 | Press release dated December 19, 2019. |
C:
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.
| ADAMIS PHARMACEUTICALS CORPORATION | ||
| Dated: December 26, 2019 | By: | /s/ Robert O. Hopkins |
| Name: | Robert O. Hopkins | |
| Title: | Chief Financial Officer | |
| This ‘8-K’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 12/26/19 | None on these Dates | ||
| For Period end: | 12/19/19 | |||
| 11/22/19 | ||||
| List all Filings | ||||