Attached files
| file | filename |
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| EX-99.1 - EX-99.1 - IMMUNE PHARMACEUTICALS INC | exhibit1.htm |
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 20, 2011 |
EpiCept Corporation
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 000-51290 | 52-1841431 |
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_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 777 Old Saw Mill River Rd., Tarrytown, New York | 10591 | |
|
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
| Registrant’s telephone number, including area code: | 914-606-3500 |
Not Applicable
______________________________________________
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:
[ ] 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))
Item 8.01 Other Events.
On December 20, 2011 EpiCept Corporation (the "Company") was granted permission by the U.S. Food and Drug Administration (the "FDA") to initiate immediately the Phase III clinical development of AmiKet™. AmiKet™ (4% amitriptyline, 2% ketamine) is a prescription topical cream intended for the treatment of chemotherapy-induced peripheral neuropathy ("CIPN") following taxane-based therapy.
The FDA indicated that a CIPN treatment protocol submitted by the Company will be reviewed expeditiously for a Special Protocol Assessment ("SPA").
The Company has submitted its draft meeting minutes for FDA concurrence and upon receipt of the FDA official meeting minutes will provide more details regarding the clinical and non-clinical package required prior to an NDA filing.
Item 9.01 Financial Statements and Exhibits.
99.1 Press release of Epicept Corporation, dated December 23, 2011.
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.
| EpiCept Corporation | ||||
| December 23, 2011 | By: |
/s/ Robert W. Cook
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| Name: Robert W. Cook | ||||
| Title: Chief Financial Officer | ||||
Exhibit Index
| Exhibit No. | Description | |
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99.1
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Press release of EpiCept Corporation, dated December 23, 2011. |