Current Report Filing (8-k)
November 02 2022 - 4:32PM
Edgar (US Regulatory)
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2022-11-02
2022-11-02
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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
November
2, 2022
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)
(201)
750-2646
(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)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in 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. ☐
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
ELTP |
|
OTCQB |
Item
7.01 Regulation FD Disclosure.
On
November 2, 2022, in a press release, Elite Pharmaceuticals, Inc., or Elite, reported positive results from pivotal fed and fasted bioequivalence
studies for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. The results indicate
that the generic product is bioequivalent to the branded product
The
studies were single-dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasting
states. The results indicate that the generic product is bioequivalent to the branded product. Elite
is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.
A
copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01
and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings
under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof,
except as shall be expressly set forth by specific reference in any such filing.
Caution
Concerning Forward-Looking Statements
This
Current Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of
1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation
to the subject matter of this current report, readers are cautioned that such forward-looking statements involve risks and uncertainties
including, without limitation, Elite’s ability to obtain FDA approval of the ANDA or the timing of such approval process, delays,
uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results,
performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied
by these forward-looking statements. These forward-looking statements are not guarantees of future action or performance, the timing
or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory
authorities, intellectual property protections and defenses, are discussed in Elite’s filings with the Securities and Exchange
Commission, including its reports on Forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements,
whether as a result of new information, future events or otherwise.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
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.
Dated:
November 2, 2022 |
ELITE PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/
Nasrat Hakim |
|
|
Nasrat
Hakim, President and CEO |
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