Elite Pharmaceuticals Inc (ELTP)

[ARbigguy1]

FACT - Elites SequestOx has clear path forward!
Only believe the facts and not the speculation of others!

http://ir.elitepharma.com/profiles/investor/secDL.asp?c=1053369&ID=000114420416141038/0001144204-16-141038#LoadingArea

ELITE PHARMACEUTICALS INC /NV/ - 8-K (Filed: 22-12-2016)

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
 
December 22, 2016 (December 21, 2016)
Date of Report (Date of earliest event reported)
 
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Nevada
 001-15697
  22-3542636
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
 
165 Ludlow Avenue, Northvale, New Jersey 07647
(Address of principal executive offices)
 
[phone]
(Registrant’s telephone number, including area code)
 
(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.
Elite Pharmaceuticals, Inc. ("Elite" or the “Company") met with the U.S. Food and Drug Administration (the “FDA”) on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOxTM. Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter. The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.
 
For more information on the SequestOx end-of-review meeting, please see the December 22, 2016 press release, a copy of which is furnished herewith as Exhibit 99.1.